Health Canada F-23_Test Method for Utility Lighters
IEC60601-1_2005 Overview
IEC60601-1:2005 An OverviewMedical electrical equipmentPart 1:General requirements for basic safety and essential performanceWhy have Standards?Standards are considered to be a known method to determine minimum levels of safety Standards bring a consistency and repeatability to testing Standards are “consensus” documents2/ GE /Why have Standards (cont.)?Increases marketability of your product Increases market acceptance of your product via: • Wide acceptance of national test agencies (CB scheme) • Fewer “national” tests means your product gets to market quicker (competitive advantage) • May provide support with legal issues3/ GE /A Sample of “601” National StandardsAustralia / New Zealand: AS/NZS 3200-1-0 Canada: CAN/CSA C22.2 No. 601.1 EU Countries: EN 60601-1 Japan: JIS T-0601-1 Korea: Based on IEC 60601-1 Unites States: UL 60601-14/ GE /History of IEC60601-15/ GE /IEC60601-1 Series6/ GE /IEC 60601-12-21 2-20 2-19 2-18 2-17 2-16 2-15 2-14 2-13 2-12 2-11 2-102-26 2-25 2-24 2-23 2-222-272-282-33 2-34 2-35 2-3660601-1-4Software60601-1-6Usability2-37 2-38 2-39 2-40 2-41 2-42 2-43 2-44 2-45 2-4660601-1-3Radiation60601-1-8Alarms60601-1 MEE60601-1-2EMCEnvironment60601-1-960601-1-10Controllers2-47 2-48 2-49 2-50 2-51 2-5260601-1-1Systems60601-1-11Home Care2-09 2-08 2-07 2-06 2-05 2-04Collateral Standards2-53 2-54 2-55 2-03 2-02 2-57 2-01 2-59 2-58 2-567/ GE /Particular StandardsVarious Country Requirements - the EUMedical devices must comply with the European Medical Device Directive (93/42/EEC) The MDD outlines “essential requirements” Risk analysis is needed (ISO 14971)8/ GE /Various Country Requirements - the USMedical devices must be “safe and effective” (FDA) The FDA “accepts” compliance to various safety standards, such as IEC 60601. Risk analysis is needed as a part of design validation (QSR: 21CFR 820.30g))9/ GE /Various Country Requirements - CanadaMedical devices must be “safe and effective” (Health Canada) Health Canada “accepts” compliance to various safety standards, such as CAN/CSA C22.2 No. 601.1 (Basically the same as IEC 60601) Risk analysis is needed10 / GE /11/GE /Various Country Requirements –Asia, South America, Eastern Europe9Medical devices must be “safe”9Many countries “accept”compliance to IEC 60601-1 and many have written standards based on this document9Risk analysis is becoming required in more countries12/GE /Why the Third Edition?-IEC Standard revision practices 9Amendent 1,Nov-19919Amendent 2,March-199513/GE /Introduction to the 3rd Edition9The first major change is the Introduction of the concept for Essential Performance9The risk management philosophy is the most significant change to the standard.9Compliance with 3rd edition is possible only if the manufacturer has a risk management process complying with ISO 14971.9Risk Management File must be submitted with type testingIEC 60601-2-43: Interventional X-ray16/GE /Clause 3.27 Essential Performance¾Performance necessary to achieve freedom from unacceptable riskNote: ESSENTIAL PERFORMANCE is most easily understood by considering whether its absence or degradation would result in anunacceptable RISK.17/GE /Risk ManagementISO 14971: Medical Devices —RiskManagement —Application of Risk Management to Medical Devices18/GE /Hazard 危害损害的潜在源Potential source of harmHarm 损害对人健康的实际伤害或侵害,或对财产或环境的侵害。
flammability of textile products in Canada
in CanadaOur mission is to help the people of Canada maintain and improve their health.Health CanadaPublished by authority of the Minister of HealthÉgalement disponible en français sous le titre Inflammabilité des produits textiles au CanadaThis publication can be made available (in/on computer diskette/large print/audio-cassette/braille) upon request.© Her Majesty the Queen in Right of Canada,2003 Cat.No.H46-2/03-306ISBN 0-662-67236-4T able of ContentsPreface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iiiLegislation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 T esting Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 Factors Affecting T extile Flammability . . . . . . . . . . . . . . . . . .7 Canadian Exports to the United States . . . . . . . . . . . . . . . . .12 Roles and Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . .13APPENDIX A – List of Health Canada ProductSafety Offices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17 APPENDIX B – Canadian T extile T esting Laboratories . . . . .20 APPENDIX C – Canadian Information Resources . . . . . . . .23• Product Safety Programme (PSP)• Hazardous Products Act and Regulations• Children’s Sleepwear:Flammability RequirementGuidelines• T est Method for the Flammability of T extiles• T est Method for the Flammability ofChildren’s Sleepwear• Guide to the Textile Labelling Act and theT extile Labelling and Advertising Regulations APPENDIX D – United States Information Resources . . . .25• Consumer Product Safety Commission (CPSC)• Standard for the Flammability of Clothing T extiles• Standard for the Flammability of Children’sSleepwear:Sizes 0 through 6x• Standard for the Flammability of Children’sSleepwear:Sizes 7 through 14PrefaceThe intent of this document is to:•provide information about the legislation in Canada that applies to hazardous or potentially hazardous products•explain how the legislation applies to general textile products and children’s sleepwearGeneral textile products are defined,in accordancewith the legislation,as all consumer products made inwhole or in part of textile products,other thanchildren’s sleepwear,bedding,dolls,plush toys,softtoys,carpets,rugs,tents,and mattresses,which mustcomply with different legislative requirements.General textile products include such items as fabric,drapery,outerwear and daywear.•describe the testing methods for general textile products and children’s sleepwear•discuss the influences of fibre content,fabric construction and design on the flammability characteristics of the finished textile products•outline the roles and responsibilities of industry and governmentT o obtain information on the legislative requirements for consumer textile products not covered in this document, refer to the ’Hazardous Products Act and Regulations’ listed in Appendix C – Canadian Information Resources,on page 23 of this document.LegislationConsumer Product Safety (CPS) of Health Canada’s Product Safety Programme (PSP) works closely with partners and stakeholders to protect consumers and children from product-related hazards and to promote the safe use of products.CPS gets its regulatory authority from the Hazardous Products Act (HPA),which covers the sale,importation and advertising of a variety of hazardous or potentially hazardous products.The onus is on industry to comply with the legislation.Enforcement actions taken by Product Safety Officers on noncompliant products range from negotiation with industry for the voluntary removal of these products from the market to seizure and/or prosecution under the HPA.Certain consumer products are prohibited from sale, importation or advertising in Canada.Other products are restricted,and must meet specific regulatory requirements prior to sale,importation or advertising.General textile products and certain children’s sleepwear (sleepwear for infants up to 7 kg,as well as hospital sleepwear,polo pyjamas and sleepers in sizes up to and including 14x) are prohibited if they do not meet minimum flammability requirements.Other children’s sleepwear (nightgowns,nightshirts,dressing gowns, bathrobes,housecoats,robes,pyjamas and baby-doll pyjamasin sizes up to and including 14x) have specific regulatory requirements that must be met prior to sale.Flammability requirements for general textile products have been in effect under Item 4 of Part I of Schedule I to the HPA since 1971.These products,when tested in accordance with ASTM Method D1230-61:Standard Method of Test for Flammability of Clothing Textiles,are prohibited if they have a flame spread time of:•3.5 seconds or less,where the products do not have a raised fibre surface;or•4 seconds or less,where the products have a raised fibre surface and exhibit ignition or fusion of their base fibresMore stringent flammability requirements were established in 1971 for all children’s sleepwear in sizes up to and including 6x under Item 5 of Part I of Schedule I to the HPA.In 1987,the flammability requirements for children’s sleepwear were modified by developing even more stringent requirements for loose-fitting children’s sleepwear such as nightgowns,robes, tailored pyjamas and baby-doll pyjamas in sizes up to and including 14x under Item 40 of Part II of Schedule I to the HPA.Children’s polo pyjamas and sleepers,children’s sleepwear designed for hospital use,and sleepwear designed for infants up to 7 kg,remained subject to the flammability requirements under Item 5 of Part I of Schedule I to the HPA.T o provide school-age children with the same level of protection as preschoolers,Item 5 was extended to include productsin sizes up to and including 14x.Children’s sleepwear governed under Item 5 of Part I of Schedule I to the HPA,when tested in accordance with ASTM Method D1230-61:Standard Method of Test for Flammabilityof Clothing Textiles,are prohibited if they have a flame spread time of:•7 seconds or less (for products with or without a raised fibre surface,and irrespective of a base burn)Children’s sleepwear governed under Item 40 of Part II of Schedule I to the HPA,when tested in accordance with the Flame Resistance T est set out in Schedule I of the Hazardous Products (Children’s Sleepwear) Regulations,must have:•an average char length for five specimens that does not exceed 178 mm;and•not more than one individual specimen with a char length equal to the full length of the specimen (254 mm)For additional information on the HPA flammability requirements for children’s sleepwear,refer to the ’Children’s Sleepwear:Flammability Requirement Guidelines’ listed in Appendix C – Canadian Information Resources,on page 23of this document.T esting MethodsA) General T extile Products (Item 4 of Part Iof Schedule I to the HPA);and Children’sSleepwear (Item 5 of Part I of Schedule Ito the HPA)In accordance with ASTM Method D 1230-61:Standard Method of Test for Flammability of Clothing Textiles,a dried piece of fabric measuring 5.1 cm x 15.2 cm (2″x 6″) is mounted ata 45 degree angle to the horizontal,and a standardized flame is applied for one second to the surface near the lower end of the fabric.The flame spread time is the time taken for any flaming to proceed a distance of 12.7 cm (5″) up the fabric, and is automatically recorded by the burning of a stop cord.Before a product sample is tested for flammability,preliminary trials are conducted on fabric specimens cut from the sample in different directions to determine the direction in which to cut the test specimens and the surface to test whereby the fabric burns most rapidly.Once this has been established,the flammability of the product sample is determined by measuring the flame spread time for five test specimens from the same sample and averaging the results.If the average flame spread time is equal to or less than 3.5 seconds for general textile products with a flat fibre surface,4 seconds for general textile products with a raised fibre surface,or 7 seconds for children’ssleepwear,or if some specimens do not burn (i.e.,do not ignite or ignite but extinguish),five additional specimens from the sample are tested.The flame spread time of the product sample is then the average flame spread time for the ten specimens,or for the number of specimens that burned.Borderline or extremely variable flammability test results are followed up by testing at least one,and preferably two or more, additional product samples to ascertain reasonable consistency of the test results.For detailed information on this test,refer to the ’T est Method for the Flammability of T extiles – Method F-01’ listed in Appendix C – Canadian Information Resources,on page 23of this document.B) Children’s Sleepwear (Item 40 of Part II ofSchedule I to the HPA)In accordance with the Flame Resistance T est set out in Schedule I of Hazardous Products (Children’s Sleepwear) Regulations,product samples are first washed and dried or dry cleaned according to specified procedures.Five specimens per product,each measuring 89 mm x 254 mm (3.5″x 10″),are held vertically and tested individually by applying a standardized flame for three seconds to the base,and the average char length is determined.For detailed information on this test,refer to the ’T est Method for the Flammability of Children’s Sleepwear – Method F-17’listed in Appendix C – Canadian Information Resources,on page 23 of this document.Factors Affecting T extile FlammabilityFibre content,fabric construction,fabric weight and fabric finishes can all affect the flammability or rate of burn of textiles. All textiles will burn to varying degrees if exposed long enough to a flame or an intense heat source.When discussing any one factor below,it is assumed that all other pertinent factors remain constant.A) Fibre ContentWith regards to flammability,fabrics may be classified generally according to fibre content:•readily flammable:These fibres ignite readily and burn rapidly,leaving a light ash residue (e.g.,cotton,acetate,triacetate,rayon,ramie).•moderately flammable:These fibres are more difficult to ignite.The synthetics tend to melt and drip,sometimes self-extinguishing upon removal of the ignition source (e.g.,acrylic,nylon,polyester,olefin,silk).•relatively nonflammable:In general,these fibres will not support combustion after removal of the ignition source (e.g.,wool,modacrylic, vinyon,saran).BlendsFabrics made of two or more fibres (blends) display flammability characteristics that are different from those of the individual fibres,and testing is the only way to ascertain the flammability of the blend.For example,although polyester is less flammable than cotton,some cotton/polyester blends have been shown to burn rapidly and generate more heat than 100% cotton fabrics. This is due to a “scaffolding” effect,where the charred cotton in the blend acts as a support or scaffold for the polyester fibres. The melting polyester in the blend does not drip away as it may do in 100% polyester fabrics,and continues to burn.Blended fleece fabrics such as 80% cotton/20% polyester may burn quickly like 100% cotton fleece because the brushed surface can be 100% cotton,while the base may be a blendof 50% cotton/50% polyester or 60% cotton/40% polyester.A flame can quickly pass over the raised surface of the fleece, igniting the readily flammable cotton.Once the base of the fabric is ignited,the moderately flammable polyester slows down the rate of burn to one somewhat slower than thatof a pure cotton fabric of equal weight and construction.B) Fabric ConstructionFor textiles,the critical factor in determining flammability ratings for varying construction techniques is the availability of bustion is accelerated if air can permeate a fabric easily.The more loosely woven a fabric,the more combustible it is,and the faster the flame will travel over the surface of the fabric.For example,a lightweight tightly woven polyester fabric may be difficult to ignite,whereas a lightweight loosely woven (mesh) polyester fabric may fail flammabilty testing.Fabrics with a raised fibre surface require special consideration. Fleece-style fabrics,flannelettes and terry towelling are some examples of construction which allow individual fibres or yarns to be exposed readily to accidental contact with ignition sources.This,combined with the fact that air readily penetrates and circulates around these loose fibres and yarns,increases the hazard level of raised fibre surface fabrics.The flammability hazard with raised fibre surface fabrics involves the phenomenon called “surface flash” whereby a flame can travel rapidly over the fabric surface,singeing the fibre ends. This flash,in itself,may not be dangerous unless the intensityof the flame is sufficient to ignite the base fabric.In testing,this is known as timed surface flash with base burn.C) Fabric WeightA lightweight fabric tends to be more flammable than a heavier weight fabric of the same fibre content and fabric construction. For example,rayon chiffon usually fails to meet the HPA flammability requirements while rayon georgette generally passes.The georgette yarns are more tightly twisted and the weave is more tightly compacted than chiffon.Consequently, the georgette fabric is more difficult to ignite,and when it does ignite,the rate of burn is slower because of the restricted availability of oxygen.D) Fabric FinishesA chemical or mechanical finish alters the surface of a fabric and in doing so affects the flammability of that fabric.Finishes not designed specifically to retard flammability must be considered as unknown variables that influence the total flammability of the textile product.Only through testing can the effect of the system be ascertained.For example,enzyme washes designed to reduce the pile on 100% cotton fleece tend to reduce the surface flash by shortening and compacting the loose cotton fibres.The proper choice of fabrics and design criteria will allow children’s sleepwear to meet the applicable HPA flammability requirements without treatment with fire retardants.If fire retardants are used,they must meet strict toxicological testing set out in the Hazardous Products (Children’s Sleepwear) Regulations.Canadian Exports to the United StatesGeneral textile products and children’s sleepwear producedin Canada and shipped to the United States are subject to textile flammability standards issued and enforced by the United States Consumer Product Safety Commission (CPSC). For more information,refer to Appendix D – United States Information Resources,on page 25 of this document.Flammability requirements for general textile products and children’s sleepwear are similar in Canada and the United States,but there are some differences such as the requirements and procedures for laundering.Canadian companies exporting to the United States are advised to ensure compliance with the United States standards and have their goods tested prior to export.For a partial list of laboratories which provide textile testing services,refer to Appendix B – Canadian T extile T esting Laboratories,on page 20 of this document.Roles and ResponsibilitiesThe roles and responsibilities of government and industry in ensuring the safety of general textile products and children’s sleepwear include,but are not limited to,the following:A) Health Canada•develop and enforce the legislation•educate and inform industry and consumers•monitor the marketplace,including following up on industry and consumer complaints,recalls by industry and the United States CPSC,and referrals from other agencies or governments•obtain samples for testing to determine compliance with the HPA flammability requirementsFor products that do not comply with the HPA flammability requirements:•take enforcement actions depending on the risk of the products to the consumer,including:–providing a verbal or written warning for corrective action to be taken by industry–negotiating with industry to voluntarily discontinue the sale of these products through removal,disposal or recall atindustry’s expense–seizing noncompliant products and/or prosecuting industry under the HPA•follow up with the supplier to ensure that the same noncompliant fabric was not sold to other manufacturers•inform the United States CPSC if the noncompliant product or fabric has been shipped to the United States•issue a public warning or advisory (press release and/or information bulletin) if the risk to the public is determined to be seriousB) Mills/Finishers/Importers•ensure that the fabric (yard goods) they are producing, finishing or importing meets the basic HPA flammability requirements for general textile products•if the fabric is intended for children’s sleepwear,ensure that it meets the more stringent HPA flammability requirements for these products•advise their customers in the event that the fabric they sell meets the basic HPA flammability requirements for general textile products but not the more stringent HPA flammability requirements for children’s sleepwear•test the fabric as necessary to ensure continued compliance with the legislation•co-operate in any removal,disposal or recall from the marketplace of their products found to be noncompliantC) Clothing Manufacturers•ensure that the fabric they are using meets the basic HPA flammability requirements for general textile products•if the fabric is used to manufacture children’s sleepwear, ensure that it meets the more stringent HPA flammability requirements which are applicable to the style of children’s sleepwear they are producing•request test results from their supplier or contract their own testing as deemed necessary•co-operate in any removal,disposal or recall from the marketplace of their products found to be noncompliantD) Retailers/Buyers•ensure that the products being purchased meet the applicable HPA flammability requirements•if products are being purchased outside of Canada,ensure that they meet the applicable HPA flammability requirements prior to importation•when notified of a removal,disposal or recall of a noncompliant product,immediately remove the affected product from sale•do not promote children’s daywear as suitable for use as sleepwear•segregate children’s sleepwear from daywear to assist the consumer in making safe choices for their children– CONSUMER SAFETY IS A SHAREDRESPONSIBILITY –APPENDIX AList of Health Canada Product Safety OfficesBritish Columbia and Y ukon#210 – 3625 Lougheed Highway T el:(604) 666-5003 Vancouver,British Columbia Fax:(604) 666-5988V5M 2A6Bby_Prodsafe@hc-sc.gc.caAlberta and Northwest T erritoriesCanada Place,Room 839T el:(780) 495-26269700 Jasper Avenue Fax:(780) 495-2624 Edmonton,Alberta Edm_Prodsafe@hc-sc.gc.ca T5J 4C3Harry Hays Building,Room 282T el:(403) 292-4677220 – 4th Avenue South East Fax:(403) 292-4644 Calgary,Alberta Cal_Prodsafe@hc-sc.gc.ca T2G 4X3Manitoba and Saskatchewan510 Lagimodiere Boulevard T el:(204) 983-5490 Winnipeg,Manitoba Fax:(204) 984-0461R2J 3Y1Mb_Prodsafe@hc-sc.gc.caRoom 412,Federal Building T el:(306) 975-4502101 – 22nd Street East Fax:(306) 975-6040 Saskatoon,Saskatchewan Sk_Prodsafe@hc-sc.gc.ca S7K 0E1Ontario2301 Midland Avenue T el:(416) 973-4705T oronto,Ontario Fax:(416) 973-1746M1P 4R7T or_Prodsafe@hc-sc.gc.caRoom 500T el:(905) 572-2845150 Main Street West Fax:(905) 572-2047 Hamilton,Ontario T or_Prodsafe@hc-sc.gc.ca L8P 1H8Quebec1001 ouest,rue urent T el:(450) 646-1353 Longueuil,Quebec Fax:(450) 928-4066J4K 1C7Quebec_Prod@hc-sc.gc.ca901 Cap-Diamant,Suite 266-1T el:(418) 648-4327 Quebec City,Quebec1-800-561-3350G1K 4K1Fax:(418) 649-6536Quebec_Prod@hc-sc.gc.caAtlantic1505 Barrington Street,Suite 1625T el:(902) 426-8300 Halifax,Nova Scotia Fax:(902) 426-6676B3J 3Y6Atlantic_ProdSafe@hc-sc.gc.ca10 High Field Street,1st Floor T el:(506) 851-6638 Moncton,New Brunswick Fax:(506) 851-3197E1C 9V5Atlantic_ProdSafe@hc-sc.gc.caThe John Cabot Building,3rd Floor T el:(709) 772-405010 Barter’s Hill Fax:(709) 772-5945P.O.Box 1949Atlantic_ProdSafe@hc-sc.gc.ca St.John’s,NewfoundlandA1C 5R4NationalConsumer Product Safety Bureau T el:(613) 954-0104 MacDonald Building,4th Floor Fax:(613) 952-1994123 Slater Street cps-spc@hc-sc.gc.ca Ottawa,OntarioK1A 0K9APPENDIX BCanadian T extile T esting LaboratoriesNOTICE:This listing of laboratories implies no certification or endorsement by Health Canada,nor is it necessarily a complete listingof all laboratories in Canada that provide textile testing services.Many of these laboratories can also do flammability testing.AlbertaT extile Analysis Service T el:(780) 492-3832 Department of Human Ecology Fax:(780) 492-4111 Room B33,Human Ecology BuildingUniversity of AlbertaEdmonton,AlbertaT6G 2N1ManitobaT extile T esting Service T el:(204) 474-8509 Faculty of Human Ecology Fax:(204) 474-7593 University of ManitobaH501 Duff Roblin BuildingWinnipeg,ManitobaR3T 2N2OntarioBodycote Materials T esting Canada Inc.T el:(905) 822-4111 T extile Department Fax:(905) 823-1446 2395 Speakman DriveMississauga,OntarioL5K 1B3MTL-ACTS T el:(905) 771-5723 Consumer Products Division Fax:(905) 771-5724 of Bureau Veritas8220 Bayview Avenue,Suite 207Thornhill,OntarioL3T 2S2QuebecCentre des technologies textiles/T el:(450) 778-1870 T extile T echnology Centre Fax:(450) 778-3901 3000,rue BoulléSaint-Hyacinthe,QuebecJ2S 1H9Bodycote Materials T esting Canada Inc.T el:(514) 697-3273 121,Hymus Boulevard Fax:(514) 697-2090 Pointe Claire,QuebecH9R 1E6Intertek T esting Services T el:(514) 631-3100 1829,32nd Avenue Fax:(514) 631-1133 Lachine,QuebecH8T 3J1NationalProduct Safety Laboratory T el:(613) 952-3645 1800 Walkley Road Fax:(613) 954-8515 Ottawa,OntarioK1A 0L2APPENDIX CCanadian Information ResourcesNOTICE:For further information on textile products,contact a Health Canada Product Safety Office (refer to Appendix A – List of Health Canada Product Safety Offices,on page 17 of this document) or visit the following:•Product Safety Programme (PSP) www.hc-sc.gc.ca/psp•Hazardous Products Act and Regulations http://laws.justice. gc.ca/en/H-3/index.html•Health Canada,1998.Children’s Sleepwear:Flammability Requirement Guidelines – Policy Guidelines for the Children’s Sleepwear Requirements under the Hazardous Products Act, 98-EHD-221.http://www.hc-sc.gc.ca/ehp/ehd/catalogue/ psb_pubs/sleepwear.pdf•Health Canada,2000.T est Method for the Flammability ofT extiles.Method F-01.– applicable to Items 4 and 5 of Part I of Schedule I to theHazardous Products Act– includes ASTM Method D1230-61:Standard Method of Test for Flammability of Clothing Textileshttp://www.hc-sc.gc.ca/ehp/ehd/psb/laboratory/f-01.pdf•Health Canada,2001.T est Method for the Flammability of Children’s Sleepwear.Method F-17.– applicable to Item 40 of Part II of Schedule I to theHazardous Products Acthttp://www.hc-sc.gc.ca/ehp/ehd/psb/laboratory/f-17.pdf•Industry Canada,2000.Guide to the Textile Labelling Actand the T extile Labelling and Advertising Regulationshttp://strategis.ic.gc.ca/pics/cp/textile.pdfAPPENDIX DUnited States Information Resources•Consumer Product Safety Commission (CPSC)•CPSC 16 CFR Part 1610 – Standard for the Flammability of Clothing Te xtile s /nara/cfr/ waisidx_00/16cfr1610_00.html•CPSC 16 CFR Part 1615 – Standard for the Flammabilityof Children’s Sleepwear:Sizes 0 through 6X (FF 3-71)/nara/cfr/waisidx_00/16cfr1615_00.html•CPSC 16 CFR Part 1616 – Standard for the Flammabilityof Children’s Sleepwear:Sizes 7 through 14 (FF 5-74)/nara/cfr/waisidx_00/16cfr1616_00.html。
Trodelvy产品说明书
Trodelvy® (sacituzumab govitecan‐hziy)(Intravenous)Document Number: MH‐0532 Last Review Date: 03/01/2022Date of Origin: 06/02/2020Dates Reviewed: 06/2020, 09/2020, 01/2021, 05/2021, 03/2022I.Length of AuthorizationCoverage will be provided for six months and may be renewed.II.Dosing LimitsA.Quantity Limit (max daily dose) [NDC Unit]:∙Trodelvy 180 mg single-dose vial:12 vials every 21 daysB.Max Units (per dose and over time) [HCPCS Unit]:∙432 billable units weekly for two doses every 21 daysIII.Initial Approval Criteria 1Coverage is provided in the following conditions:Submission of medical records (chart notes) related to the medical necessity criteriais REQUIRED on all requests for authorizations. Records will be reviewed at thetime of submission. Please provide documentation related to diagnosis, steptherapy, and clinical markers (i.e. genetic and mutational testing) supportinginitiation when applicable. Medical records may be submitted via direct uploadthrough the PA web portal or by fax.∙Patient at least 18 years of age; ANDUniversal Criteria 1∙Therapy will NOT be substituted for or used in combination with irinotecan; AND∙Patients that are homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele will be closely monitored for adverse reactions; AND∙Therapy will not be used in combination with UGT1A1 inhibitors (e.g., nilotinib, regorafenib, etc.) or inducers (e.g., phenytoin, carbamazepine, etc.); AND∙Used as single agent therapy; ANDBreast Cancer † ‡ 1-3∙Patient has unequivocal triple-negative disease [TNBC] (i.e., estrogen, progesterone, and HER2-negative)*; AND∙Patient was previously treated with at least two systemic therapies, at least one of them for metastatic disease; ANDo Patient has recurrent unresectable, locally advanced, or metastatic disease; ORo Patient has inflammatory breast cancer with no response to preoperative systemic therapyUrothelial Cancer (Bladder Cancer)† ‡ 1,2,10∙Patient has one of the following diagnoses:o Locally advanced or metastatic urothelial carcinoma; ORo Muscle invasive bladder cancer with local recurrence or persistent disease in a preserved bladder ‡; ORo Metastatic or local bladder cancer recurrence post-cystectomy ‡; ORo Primary carcinoma of the urethra ‡; ANDUsed for recurrent (excluding recurrence of stage T3-4 disease or palpable inguinal lymph nodes) or metastatic disease; ORo Metastatic upper genitourinary (GU) tract tumors ‡; ORo Metastatic urothelial carcinoma of the prostate ‡; AND∙Patient was previously treated with platinum-containing chemotherapy and programmed death (PD-1 or PD-L1)-directed therapy (e.g., avelumab, nivolumab, atezolizumab,durvalumab, etc.)† FDA approved indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug∙Immunohistochemistry (IHC) assay is 0 or 1+; OR∙Dual-probe in situ hybridization (ISH) assay indicating (Group 5) HER2/CEP17 ratio <2.0 AND average HER2 copy number <4.0 signals/cell; OR∙Concurrent dual-probe ISH and IHC assay results indicating one of the following: o(Group 2) HER2/CEP17 ratio ≥2.0 AND average HER2 copy number <4.0 signals/cell and concurrent IHC 0-1+ or 2+; ORo(Group 3) HER2/CEP17 ratio <2.0 AND average HER2 copy number ≥6.0 signals/cell and concurrent IHC 0-1+; ORo(Group 4) HER2/CEP17 ratio <2.0 AND average HER2 copy number ≥4.0 and <6.0 signals/cell and concurrent IHC 0-1+ or 2+9∙Immunohistochemistry (IHC) assay: Sample is considered ER/PR negative if the percentage of cancer cells staining on evaluation is <1% OR 0% of tumor cell nuclei are immunoreactiveNote: A sample may be deemed uninterpretable for ER or PR if the sample is inadequate(insufficient cancer or severe artifacts present, as determined at the discretion of thepathologist), if external and internal controls (if present) do not stain appropriately, or ifpre-analytic variables have interfered with the assay’s accuracy.IV.Renewal Criteria 1Coverage can be renewed based upon the following criteria:∙Patient continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performancestatus, etc. identified in section III; AND∙Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND∙Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe hypersensitivity and infusion-related reactions, severe nausea/vomiting, severeneutropenia/febrile neutropenia, severe anemia, severe diarrhea, etc.V.Dosage/Administration 1Breast Cancer/ Bladder Cancer Administer 10 mg/kg as an intravenous infusion once weekly on Days 1 and 8 of 21-day treatment cycles. Continue treatment until disease progression or unacceptable toxicity. Do not administer doses greater than 10 mg/kg.VI.Billing Code/Availability InformationHCPCS Code:∙J9317 – Injection, sacituzumab govitecan-hziy, 2.5 mg; 1 billable unit = 2.5 mgNDC:∙Trodelvy 180 mg lyophilized powder in a single-dose vial: 55135-0132-xxVII.References1.Trodelvy [package insert]. Morris Plains, NJ; Immunomedics, Inc; October 2021. AccessedFebruary 2022.2.Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCNCompendium®) sacituzumab govitecan. National Comprehensive Cancer Network, 2022.The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONALCOMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® aretrademarks owned by the National Comprehensive Cancer Network, Inc. To view the mostrecent and complete version of the Compendium, go online to . AccessedFebruary 2022.3.Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology(NCCN Guidelines®) for Breast Cancer 2.2022. National Comprehensive Cancer Network, 2022. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCNGUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to .Accessed February 2022.4.Fahrenbruch R, Kintzel P, Bott AM, et al. Dose Rounding of Biologic and CytotoxicAnticancer Agents: A Position Statement of the Hematology/Oncology PharmacyAssociation. J Oncol Pract. 2018 Mar;14(3):e130-e136.5.Hematology/Oncology Pharmacy Association (2019). Intravenous Cancer Drug Waste IssueBrief. Retrieved from /images/hopa/advocacy/Issue-Briefs/Drug_Waste_2019.pdf6.Bach PB, Conti RM, Muller RJ, et al. Overspending driven by oversized single dose vials ofcancer drugs. BMJ. 2016 Feb 29;352:i788.7.Bardia A, Mayer IA, Vahdat LT, et al. Sacituzumab Govitecan-hziy in RefractoryMetastatic Triple-Negative Breast Cancer. N Engl J Med. 2019 Feb 21;380(8):741-751. doi:10.1056/NEJMoa1814213.8.Wolff AC, Hammond EH, Allison KH, et al. Human epidermal growth factor receptor 2testing in breast cancer: American Society of Clinical Oncology/College of AmericanPathologists Clinical Practice Guideline Focused Update. J Clin Oncol 2018;36:2105-2122.9.Allison KH, Hammond EH, Dowsett M, et al. Estrogen and Progesterone Receptor Testingin Breast Cancer: ASCO/CAP Guideline Update. J Clin Oncol 38:1346-1366.10.Tagawa S, Balar A, Petrylak, et al. TROPHY-U-01: A Phase II Open-Label Study ofSacituzumab Govitecan in Patients With Metastatic Urothelial Carcinoma ProgressingAfter Platinum-Based Chemotherapy and Checkpoint Inhibitors. J Clin Oncol. 2021 Aug1;39(22):2474-2485. doi: 10.1200/JCO.20.03489. Epub 2021 Apr 30.Appendix 1 – Covered Diagnosis Codes1010C50.011 Malignant neoplasm of nipple and areola, right female breastC50.012 Malignant neoplasm of nipple and areola, left female breastC50.019 Malignant neoplasm of nipple and areola, unspecified female breastC50.021 Malignant neoplasm of nipple and areola, right male breastC50.022 Malignant neoplasm of nipple and areola, left male breastC50.029 Malignant neoplasm of nipple and areola, unspecified male breastC50.111 Malignant neoplasm of central portion of right female breastC50.112 Malignant neoplasm of central portion of left female breastC50.119 Malignant neoplasm of central portion of unspecified female breastC50.121 Malignant neoplasm of central portion of right male breastC50.122 Malignant neoplasm of central portion of left male breastC50.129 Malignant neoplasm of central portion of unspecified male breastC50.211 Malignant neoplasm of upper-inner quadrant of right female breastC50.212 Malignant neoplasm of upper-inner quadrant of left female breastC50.219 Malignant neoplasm of upper-inner quadrant of unspecified female breast C50.221 Malignant neoplasm of upper-inner quadrant of right male breastC50.222 Malignant neoplasm of upper-inner quadrant of left male breastC50.229 Malignant neoplasm of upper-inner quadrant of unspecified male breast C50.311 Malignant neoplasm of lower-inner quadrant of right female breastC50.312 Malignant neoplasm of lower-inner quadrant of left female breastC50.319 Malignant neoplasm of lower-inner quadrant of unspecified female breast C50.321 Malignant neoplasm of lower-inner quadrant of right male breastC50.322 Malignant neoplasm of lower-inner quadrant of left male breastC50.329 Malignant neoplasm of lower-inner quadrant of unspecified male breastC50.411 Malignant neoplasm of upper-outer quadrant of right female breastC50.412 Malignant neoplasm of upper-outer quadrant of left female breastC50.419 Malignant neoplasm of upper-outer quadrant of unspecified female breast C50.421 Malignant neoplasm of upper-outer quadrant of right male breastC50.422 Malignant neoplasm of upper-outer quadrant of left male breastC50.429 Malignant neoplasm of upper-outer quadrant of unspecified male breast C50.511 Malignant neoplasm of lower-outer quadrant of right female breastC50.512 Malignant neoplasm of lower-outer quadrant of left female breastC50.519 Malignant neoplasm of lower-outer quadrant of unspecified female breast C50.521 Malignant neoplasm of lower-outer quadrant of right male breastC50.522 Malignant neoplasm of lower-outer quadrant of left male breastC50.529 Malignant neoplasm of lower-outer quadrant of unspecified male breastC50.611 Malignant neoplasm of axillary tail of right female breastC50.612 Malignant neoplasm of axillary tail of left female breastC50.619 Malignant neoplasm of axillary tail of unspecified female breastC50.621 Malignant neoplasm of axillary tail of right male breastC50.622 Malignant neoplasm of axillary tail of left male breastC50.629 Malignant neoplasm of axillary tail of unspecified male breastC50.811 Malignant neoplasm of overlapping sites of right female breastC50.812 Malignant neoplasm of overlapping sites of left female breastC50.819 Malignant neoplasm of overlapping sites of unspecified female breastC50.821 Malignant neoplasm of overlapping sites of right male breastC50.822 Malignant neoplasm of overlapping sites of left male breastC50.829 Malignant neoplasm of overlapping sites of unspecified male breastC50.911 Malignant neoplasm of unspecified site of right female breastC50.912 Malignant neoplasm of unspecified site of left female breastC50.919 Malignant neoplasm of unspecified site of unspecified female breastC50.921 Malignant neoplasm of unspecified site of right male breastC50.922 Malignant neoplasm of unspecified site of left male breastC50.929 Malignant neoplasm of unspecified site of unspecified male breastC61 Malignant neoplasm of prostateC65.1 Malignant neoplasm of right renal pelvisC65.2 Malignant neoplasm of left renal pelvisC65.9 Malignant neoplasm of unspecified renal pelvisC66.1 Malignant neoplasm of right ureterC66.2 Malignant neoplasm of left ureterC66.9 Malignant neoplasm of unspecified ureterC67.0 Malignant neoplasm of trigone of bladderC67.1 Malignant neoplasm of dome of bladderC67.2 Malignant neoplasm of lateral wall of bladderC67.3 Malignant neoplasm of anterior wall of bladderC67.4 Malignant neoplasm of posterior wall of bladderC67.5 Malignant neoplasm of bladder neckC67.6 Malignant neoplasm of ureteric orificeC67.7 Malignant neoplasm of urachusC67.8 Malignant neoplasm of overlapping sites of bladderC67.9 Malignant neoplasm of bladder, unspecifiedC68.0 Malignant neoplasm of urethraD09.0 Carcinoma in situ of bladderZ85.51 Personal history of malignant neoplasm of bladderZ85.59 Personal history of malignant neoplasm of other urinary tract organAppendix 2 – Centers for Medicare and Medicaid Services (CMS)Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at:https:///medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/AJurisdiction Applicable State/US Territory ContractorE (1) CA, HI, NV, AS, GU, CNMI Noridian Healthcare Solutions, LLCF (2 & 3) AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ Noridian Healthcare Solutions, LLC5 KS, NE, IA, MO Wisconsin Physicians Service Insurance Corp (WPS)6 MN, WI, IL National Government Services, Inc. (NGS)H (4 & 7) LA, AR, MS, TX, OK, CO, NM Novitas Solutions, Inc.8 MI, IN Wisconsin Physicians Service Insurance Corp (WPS) N (9) FL, PR, VI First Coast Service Options, Inc.J (10) TN, GA, AL Palmetto GBA, LLCM (11) NC, SC, WV, VA (excluding below) Palmetto GBA, LLCNovitas Solutions, Inc.L (12) DE, MD, PA, NJ, DC (includes Arlington &Fairfax counties and the city of Alexandria in VA)K (13 & 14) NY, CT, MA, RI, VT, ME, NH National Government Services, Inc. (NGS)15 KY, OH CGS Administrators, LLC。
质量认证-加拿大GMP检查风险分级 精品
Health Products and Food Branch Inspectorate 食品与健康类产品检查员Guide-0023指南-0023Risk Classification of GMP Observations,20XX editionGMP检查发现的风险分级,20XX版Supersedes:June 1st, 2000 editionDate issued:April 4th ,20XXDate of implementation:June 1st, 20XXCe document est aussi disponible en français.本文可提供法语版TABLE OF CONTENTS目录1.0 PURPOSE目的 (3)2.0 BACKGROUND背景 (3)3.0 SCOPE范围 (3)4.0 DEFINITIONS定义: (4)5.0 GUIDE指南正文 (6)5.1 Assignment of the risk to an observation针对缺陷界定风险 (6)5.2 Assignment of the inspection rating检查评定 (7)5.2.1 Risk 1 observation:1类风险缺陷 (7)5.2.2 Risk 2 observation:2类风险缺陷 (7)5.2.3 Risk 3 observations:3类风险缺陷 (8)5.3 Additional guidance补充 (8)Appendix 1附录1 (9)Appendix 2 附录2 (12)Appendix 3附录3 (21)1.0PURPOSE目的To classify the observations noted during establishment inspections according to their risk.依据风险的程度对企业检查中的发现进行分级。
加拿大学者研发出更有效测量处方药功效的方法
加拿大学者研发出更有效测量处方药功效的方法科技部加拿大多伦多大学的研究团队开展出一种大量细胞计数法(mass cytometry),可以更快更广泛的测量处方药对人体细胞的反应及功效,提前发现细胞病变,研发出针对个人的治疗药物。
多伦多大学化学系的研究员坦纳(Scott Tanner)发现,某些细胞亚群(sub-populations of cells)对药物的反应非常明显,有助于进一步了解这些细胞亚群的连锁信号反应。
研究团队开发的大量细胞计数法,每秒可在1000个细胞内同时测量多达100种生物标志物。
并通过采用新研发出的金属原子贴附化学方法,更有效地观测细胞内稍纵即逝、不易捕捉的生物分子标的物。
哥伦比亚大学和斯坦福大学的研究人员采用多伦多大学的新技术,观察人类骨髓产生的不同形态细胞中及表面的34种物质。
研究人员不但能正确归类10多种不同类型的免疫细胞,还能观察到各类免疫细胞的内部变化,从而预知可能发生的变化。
研究人员的发现已刊登在最近的《Science》期刊上,同时该技术目前正由多伦多大学的附属企(DVS Sciences Inc.)研发上市。
该公司最近获得罗氏和辉瑞的投资Big names in life sciences are backing DVS Sciences in a $14.6 million Series A round. With biomarker analysis technology for personalized medicine, the start-up has garnered investments from the investment vehicles of drug giants Pfizer ($PFE) and Roche as well as the venture firms 5AM Ventures and Mohr Davidow Ventures. 5AM led the round.DVS plans to use its cash infusion to commercialize its system that is similar in concept to a flow cytometer and can identify up to 100 biomarkers at a time. The system, which was developed with seed money from the Ontario Institute for Cancer Research, will be used for scientific research as well as clinical trials in which researchers aim to match patients with appropriate drugs based on biomarker analyses. Cancer drug development is expected to be a key area for the system. The company has its corporate headquarters in Sunnyvale, CA, and its manufacturing and research operations in Canada."This financing is the first step in our transformation from a research-based entity to a commercial company," Scott Tanner, DVS Sciences' president, said. "We are now in a position to commercialize our innovative instrumentation and reagents that will foster the acceleration of medical research, enable personalized therapeutic diagnosis and prognosis, and transform drug discovery."Life sciences investors have had some success investing in flow cytometer technology as of late, with scientific tools giant Becton Dickinson's ($BDX) buyout of venture-backed Accuri Cytometers in Ann Arbor, MI, earlier this year. Given the potential applications of DVS Systems' technology in personalized medicine, perhaps it's no surprise to see Pfizer and Roche--two Big Pharma players with huge stakes in this field--making bets on the company through their respective investment arms.CyTOF? Mass CytometryCells stained with metal-conjugated antibodies and metallointercalators are introduced individually into an Inductively Coupled Plasma, were the cells are atomized and ionized. The atomic ions are extracted into the ion optics and time-of-flight regions where they are separated by mass and counted. The elemental signature of the cell includes the element tags introduced with the antibodies and metallointercalators. The presence of the metal tag indicates that the antibody found and bound the target biomarker, and the intensity of the signal is directly proportional to the number of antibodies bound per cell (ABC). The elemental composition of each cell is separately analyzed. In a typical cell analysis experiment, four minutes of raw data collection is sufficient for analysis of 100,000 cells independent of the number of metal tags (one or all 33).It is important to note that cells without any tagging metals cannot be detected by mass cytometry: only element tags can be registered with high sensitivity and specificity, and therefore there is no "auto-fluorescence"-like effects. Metal tags are chosen from rare elements whose natural concentration in a biological sample is below the detection limit. Unstained cells are "transparent" to the mass cytometer. A complete description of the instrument can be found in Bandura et al, 2009.这家公司所发表的论文Bendall, S.C, et al. Single-Cell Mass Cytometry of Differential Immune and Drug Responses Across a Human Hematopoietic Continuum. Science 6 May 2011: 687-696.Abdelrahman, A.I. et al. Metal-containing polystyrene beads as standards for mass cytometry. Journal of Analytical Atomic Spectrometry 25 (3):260-268, 2010.Thickett, S. C., et al. Bio-functional, lanthanidelabeled polymer particles by seeded emulsion polymerization and their characterization by novel ICP-MS detection.Journal of Analytical Atomic Spectrometry 25 (3):269-281, 2010.Abdelrahman, A.I. et al. Lanthanide- Containing Polymer Microspheres by Multiple-Stage Dispersion Polymerization for Highly Multiplexed Bioassays (vol 131, pg 15276, 2009). Journal of the American Chemical Society 132 (7):2465-2465, 2010.Berger, S., et al. Hybrid nanogels by encapsulation of lanthanide-doped LaF3 nanoparticles as elemental tags for detection by atomic mass spectrometry. Journal of Materials Chemistry 20 (24):5141-5150, 2010.Ornatsky, O. I., et al. Highly multiparametric analysis by mass cytometry. J Immunol Methods 361 (1-2):1-20, 2010.Bandura, D. R., et al. Mass Cytometry: Technique for Real Time Single Cell Multitarget Immunoassay Based on Inductively Coupled Plasma Time-of-Flight Mass Spectrometry. Analytical Chemistry 81:6813-6822, 2009.Pich, S., et al. The influence of PEG macromonomers on the size and properties ofthermosensitive aqueous microgels. Colloid and Polymer Science 287:269-275, 2009.Ornatsky, O. I., et al. Study of cell antigens and intracellular DNA by identification of element-containing labels and metallointercalators using inductively coupled plasma mass spectrometry. Analytical Chemistry 80:2539-2547, 2008Pich, S., et al. Biocompatible Hybrid Nanogels. Small 4:2171-2175, 2008.Razumienko, E., et al. Element-tagged immunoassay with ICP-MS detection: Evaluation and comparison to conventional immunoassays. Journal of Immunological Methods 336:56-63, 2008.Tanner, S. D., et al. Flow cytometer with mass spectrometer detection for massively multiplexed single-cell biomarker assay. Pure and Applied Chemistry 80:2627-2641, 2008Ornatsky, O. I., et al. Development of analytical methods for multiplex bio-assay with inductively coupled plasma mass spectrometry.Journal of analytical atomic spectrometry 23:463-469, 2008.Tanner, S. D., et al. Multiplex Bio-Assay with Inductively Coupled Plasma Mass Spectrometry: Towards a Massively Multivariate Single Cell Technology, Spectrochimica Acta Part B, 62, 188-195, 2007.Ornatsky, O. I., et al. Messenger RNA Detection in Leukemia Cell lines by Novel Metal-Tagged in situ Hybridization using Inductively Coupled Plasma Mass Spectrometry,Translational Oncogenomics 1, 1-9, 2006.Ornatsky, O. I., et al. Multiple cellular antigen detection by ICP-MS.Journal of Immunological Methods 308 (1-2) :68-76, 2006.Bandura, D. R., et al. Characterization of phosphorus content of biological samples by ICP-DRC-MS: Potential tool for cancer research.Journal of analytical atomic spectrometry 19 (1):96-100, 2004.Baranov, V. I., et al. The potential for elemental analysis in biotechnology. Journal of analytical atomic spectrometry 17 (9):1148-1152, 2002.Baranov, V. I., et al. A sensitive and quantitative element-tagged immunoassay with ICPMS detection. Analytical Chemistry 74 (7):1629-1636, 2002.Quinn, Z. A., et al. The potential for elemental analysis in proteomics. 131-132, 2002.Quinn, Z. A., et al. Simultaneous determination of proteins using an element-tagged immunoassay coupled with ICP-MS detection.Journal of analytical atomic spectrometry 17 (8):892-896, 2002。
加拿大HAP指南
(American Thoracic Society/IDSA. Am J Respir Crit Care Med 2005;171:388-416)
Hale Waihona Puke AP: ImpactIncidence
Accounts for ~15% of all nosocomial infections (2nd most common cause of NI’s after UTI’s) Number of cases per year in US: ~275,000 Extra days in the hospital: 4-9 days Average extra days in ICU: 4.3 days Direct cost (estimated) of excess hospital stay = $1.5 billion per year
Epidemiology of HAP-VAP
Hospital-Acquired Pneumonia (HAP): Definitions
HAP: Arises 48 hours or more after hospital admission Is not incubating at the time of admission Ventilator-associated pneumonia (VAP): Arises 48-72 hours or more after endotracheal intubation Healthcare-associated pneumonia (HCAP): Arises within 90 days of having been admitted to an acute care facility & pt. has resided in a nursing home or LTCF.
美国FDA分析方法验证指南中英文对照
I. INTRODUCTIONThis guidance provides recommendations to applicants on submitting analytical procedures, validation data, and samples to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products.1。
绪论本指南旨在为申请者提供建议,以帮助其提交分析方法,方法验证资料和样品用于支持原料药和制剂的认定,剂量,质量,纯度和效力方面的文件。
This guidance is intended to assist applicants in assembling information, submitting samples, and presenting data to support analytical methodologies. The recommendations apply to drug substances and drug products covered in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), product license applications (PLAs), and supplements to these applications.本指南旨在帮助申请者收集资料,递交样品并资料以支持分析方法。
这些建议适用于NDA,ANDA,BLA,PLA及其它们的补充中所涉及的原料药和制剂。
The principles also apply to drug substances and drug products covered in Type II drug master files (DMFs)。
加拿大食品检验署(CFIA).
Mission: Dedicated to safeguarding food, animals and plants, which enhances the health and well-being of Canada’s people, environment and economy.
任务: 致力于保护食品、动植物安全,从而提高加拿大人民的健康和福利,改善 环境,发展经济。
Vision: To excel as a science-based regulator, trusted and respected by Canadians and the international community.
愿景: 成为优秀的以科学为基础的决策者,得到加拿大和国际社会的信任和尊敬
Animal Health Program 动物健康项目
The program draws on the authority of the Health of Animals Act and Regulations. 该项目计划促使了
动物健康法案和条例的制定
The program is also supported by a policy framework that accords with the internationally accepted animal health authorities such as the World Organisation for Animal Health (OIE). 该项目计划得到了有关政策框架的支持,与OIE等国 际动物健康机构的精神相符
3
Animal Health Program 动物健康项目
Using the best available science as a base and internationally accepted principles as a guide, the CFIA has developed regulatory programs that are respected around the world. CFIA以最科学的方法为基础,以国际认可的原则为指引,发展调整了有关规定,受 到了国际的尊敬。 The Animal Health Program reflects the Agency’s mission by protecting Canadian livestock and poultry from serious animal diseases that could pose a risk to human health (zoonoses) or restrict trade. 动物健康项目反映了该署的任务,即保护加拿大畜禽免遭重大疫病,防止人畜共患 病或影响对外贸易。 It is this program that enables Canada to control the importation of animals and animal products from foreign countries to reduce the risk of introducing serious animal diseases, and 该项目能够使加拿大控制动物和动物产品的进口,减少动物疾病传播的危险,并且 …it is because of this program’s strength that Canadian live animals and animal products and by-products are exported to countries throughout the world. 由于该项目的力度,使加拿大活畜和动物产品,副产品可出口到世界各地 4
加拿大初级卫生医疗机构中西地那非的治疗满意度调查
慢 性 阻 塞 性 肺疾 病 患 者 , 特 发 性 肺 纤 维 化 患 者 , 及 1例 2例 以
梗 阻 性 睡 眠 呼 吸暂 停 综 合 征 患 者 。患 者 年 龄 4 — 8 岁 ( 均 2 1 平
6 岁 ) 随 访 期 1 —5 个 月 ( 均 2 8 , 2 1 平 2个 月 ) 结 果 显 示 , 基 。 与 线水平 相 比, 者 治 疗 后 6 i 患 a r n步 行 距 离 增 加 显 著 ( P一
838-Liquid Total Ground Carbon Conductive Coating技
838-Liquid DescriptionThe 838 Total Ground Carbon Conductive Coating is an economical acrylic paint that is used to create conductive, static free surfaces. Coated surfaces also serve to reduce electromagnetic or radio frequency interference (EMI/RFI) to some degree. The durable acrylic resin affords long-term protection that minimizes loss of carbon through rubbing. The cured coat withstands large temperature changes andmarine environmental conditions without cracking, which makes it suitable for a wide range of application.Applications & UsagesIts primary applications are to ground working surfaces and to avoid static, but it can also be used toprovide low cost EMI/RFI shielding, as a conductive base for some electroplating process, or anywhere in a manufacturing process where it is necessary to impart conductivity to a surface.Benefits and Features∙ Conductive Material Classification —Low Surface resistivity of 250 Ω/sq for one coat (1 mil) ∙ Tough and durable coating, salt spray tested with excellent weatherability ∙ Repairable and removable thermoplastic paint system ∙ Stronger adhesion than water based coatings∙ Corrosion-proof coat —slows or prevents substrate oxidation ∙ Rub off resistantCuring & Work ScheduleCleaner Solventb) The product must stay within the storage temperature limits stated.Service Rangestransfer efficiency.Principal ComponentsNameCAS Number Carbon Black 1333-86-4 Acrylic Resin 9003-01-4 Acetone 67-64-1 Ethanol 64-17-5 Toluene108-88-3838-LiquidProperties of Cured 838a) Surface resistance is given in Ω/sq and the corresponding conductance in Siemens (S or Ω-1)Surface Resistance by Coating ThicknessFigure 1. Carbon conductive coating surface resistance for one, two, and three coats thickness (the dots indicate typical successive coat thicknesses)1401601802002202402602800.7501.000 1.250 1.500 1.7502.000 2.250S u r f a c e R e s i s t a n c e (Ω/s q )Thickness (mil)838-Liquid Properties of Uncured 838CompatibilityChemical—Carbon doesn’t oxidize or deteriorate under a normal environment and conditions, including marine environments as seen by the salt spray test results (see page 2).The thermoplastic acrylic resin is incompatible common paint solvents like toluene, xylene, acetone, and MEK. Further, it will not withstand chronic exposures to engine oils, fuels and other similar hydrocarbons. While this makes the coating unsuitable for solvent rich environments, it does offer great repair and rework characteristics.Adhesion—The 838 coating adheres to most materials used to house printed circuit assemblies; however, it is not compatible with contaminants like water, oil, and greasy flux residues that may affect adhesion. If contamination is present, clean the surface to be coated first.plastic for superior adhesion.A TTENTION! Do not use on thin plastics or on plastics where you want to keep original surface intact. The 838 spray contains a controlled amount of solvents designed to chemically etch plastic surfaces to help adhesion by melding the acrylic coating into the plastic substrate. This prevents flaking or peeling. Using the 4351-1L thinner lessens the etching effects for chemically sensitive substrates.StorageStore between -5 °C and 40 °C [23°F and 104 °F] in dry area.838-LiquidHealth, Safety, and Environmental AwarenessPlease see the 838 Safety Data Sheet (SDS) for greater details on transportation, storage, handling and other security guidelines.Environmental Impact: The volatile organic content is 57% (517 g/L) by EPA and WHMIS standards. After dilution with 435 Thinner Cleaner, the regulated VOC drops to 34% (~330 g/L). This product meets the European Directive 2011/65/EU Annex II (ROHS); recasting 2002/95/EC.Health and Safety: The solvents in 838 can ignite if exposed to flames or sparks and can cause respiratory track irritation. If ignited, then flame flash back is possible. Use in well-ventilated area. Solvents can cause skin irritation and have some reproductive effects. Wear safety glasses or goggles and disposable gloves to avoid exposures. HMIS® RATING NFPA® 704 CODESApproximate HMIS and NFPA Risk Ratings Legend :0 (Low or none); 1 (Slight); 2 (Moderate); 3 (Serious); 4 (Severe)Application InstructionsThe 838 Total Ground TM Carbon Conductive Coating can be easily applied by the paintbrush, spray gun, or dip method.For best results, apply thin wet coats as opposed to using thick coats. We recommend a final dry film thickness of at least 1.0 mil [25 μm]. Follow the procedure below for ensure optimal conductivity. PrerequisitesClean and dry the surface of the substrate to remove∙Oil, dust, water, solvents, and other contaminantsMaterial & Equipment∙ Mixing spatula∙ Clean paint brush OR HVLP spray gun OR dip tank system ∙ Thinner/Cleaner solvent∙ Personal protection equipment (See 838-Liquid safety data sheet)3838-LiquidSpray Gun Application InstructionsRead the procedure below fully and make necessary adjustments to get the required coat thickness for your needs. Typically, one coat results in a dry film thickness of roughly 1 mil [25 μm].Spray EquipmentUse a HVLP (high-volume low pressure) spray gun using the initial settings described in the following table. Adjust these settings and recommendations as required.differ with other brands. Please consult your spray gun manufacturer’s guide.a) If no or reduced let down is performed, this may be a better tip choice.b) SCFM = standard cubic foot per minuteTo apply the required thickness by weight1.Mix paint thoroughly with a spatula or with mechanized paint mixer.2.Let down the paint with at a 1:1 (Paint:Thinner) ratio.3.Spray a test pattern. This step ensures good flow quality and helps establish appropriate distanceto avoid runs.4.At a distance of 23 to 30 cm (9 to 12 inches), spray a thin and even coat onto a vertical surface.For best results, use spray-and-release strokes with an even motion to avoid excess paint in one spot. Start and end each stroke off the surface.5.Wait 2 to 3 minutes and spray another coat. The delay avoids trapping solvent between coats.6.Apply additional coats until desired thickness is achieved. (Go to Step 3)7.Let dry for 5 minutes (flash off time) at room temperature.N OTE: Swirling the paint gun container slightly while waiting prevents settling.A TTENTION!∙Coats that are applied too thick cause runs and hampers solvent evaporation. Prefer the application of many mist coats rather than fewer thicker wet coats.To cure at Room temperature∙Let air dry 24 hoursTo heat cure∙Wait 20 min or more for the coating to be dry to handle.∙Put in an oven or under heat lamp at 65 °C for 30 min.838-Liquid N OTE: If heat curing, do not exceed 65 °C as this may cause surface defects due to solvents evaporating off too quickly.A TTENTION! If heat curing, do not exceed 65 °C as this may cause surface defects due to solvents evaporating off too quickly.Packaging and Supporting ProductsSupporting Products∙Thinner—Cat No. 435-1L, 435-4L (for quick cure and most normal substrates)∙Thinner 1—Cat No. 4351-1L, 4351-4L (for slow cure and sensitive plastics substrates)Technical SupportContact us regarding any questions, improvement suggestions, or problems with this product. Application notes, instructions, and FAQs are located at .Email: ***********************Phone: +1-800-340-0772 Ext. 1030 (Canada, Mexico & USA)+1-905-331-1396 Ext. 1030 (International)Fax: +1-905-331-2862 or 1-800-340-0773Mailing address: Manufacturing & Support Head Office1210 Corporate Drive 9347–193rd StreetBurlington, Ontario, Canada Surrey, British Columbia, CanadaL7L 5R6 V4N 4E7WarrantyM.G. Chemicals Ltd. warranties this product for 12 months from the date of purchase by the end user. M.G. Chemicals Ltd. makes no claims as to shelf life of this product for the warranty. The liability of M.G. Chemicals Ltd. whether based on its warranty, contracts, or otherwise shall in no case include incidental or consequential damage.DisclaimerThis information is believed to be accurate. It is intended for professional end users having the skills to evaluate and use the data properly. M.G. Chemicals Ltd. does not guarantee the accuracy of the data and assumes no liability in connection with damages incurred while using it.。
最新加拿大治疗产品局
加拿大治疗产品局(TPD)对“治疗窗窄和/或高毒性药物”生物等效性的几点考虑审评四部审评七室光红梅高晨燕生物等效性试验是在相同试验条件下,对受试制剂与参比制剂进行生物利用度比较的试验,其中AUC、Cmax是判断生物等效的主要参数。
我国现行的指导原则对于一般口服制剂的生物等效性标准是,经对数转换后,受试制剂AUC平均值的90%置信区间在参比制剂的80%-125%范围内,Cmax平均值的90%置信区间在参比制剂的70%-143%范围内,对于治疗窗窄的药物,范围可能应适当缩小。
最近,加拿大卫生部治疗产品局(TPD)出台了对治疗窗窄和/或高毒性药物的生物等效性指导原则确定稿。
TPD将此类药物命名为“Critical dose drugs”,在此对相关情况作简要介绍。
一、“Critical dose drugs”的定义“Critical dose drugs”是指药物剂量或浓度的较小变化,会导致剂量或浓度依赖性的治疗失败和/或出现严重不良反应的一类药物。
严重不良反应是指不良反应持久、难以恢复或不可逆、危及生命,导致患者住院或需延长住院时间,持久或严重残疾、致残,甚至死亡等不良反应。
需要药物干预以预防上述事件发生的不良反应也列为严重不良反应。
二、TPD对“Critical dose drugs”生物等效性的一般考虑1.与一般口服制剂相比,此类药物在体内较小的浓度改变可导致更为严重的不良反应,因此,在生物等效性试验中,对于参比制剂和受试制剂相似性的要求程度更高。
2.食物与参比制剂之间和食物与受试制剂之间相互作用的不一致,可能带来潜在的严重不良后果。
对于一些特殊的药物,虽然对是否进食时服用在说明书中已有所说明,但考虑到不同的食物-药物相互作用产生的潜在影响,受试者应该在空腹和进食状态下分别进行生物等效性研究。
3.考虑到此类药物的特点,有必要选择患者而不是健康受试者进行研究。
4.由于患者疾病状态的多样性,在以这些患者为受试者进行的试验中,为了符合标准,在决定受试样本量时,这些变异是重要的考虑因素。
最新加拿大移民的六大体检知识点
加拿大移民的体检知识点(1)移民加拿大需要进行身体检查。
如果申请者存在不被加拿大政府接受的健康疾病,您的申请将被拒绝,这些疾病主要是:a、对公共卫生或安全造成威胁;b、会过度加大加拿大政府在健康或福利事业上的投入。
这些疾病包括(但不局限于)性别,艾滋病,严重的肾病,严重的心脏病,高危的传染病等。
加拿大政府没有明确的列举这些疾病,裁决权在移民官。
由于国内乙肝携带者人群巨大,很多申请者关心乙肝会不会影响移民申请。
现在加拿大移民体检还不检查乙肝病毒,所以只要肝功正常就不必担心,乙肝携带或者大小三阳并且肝功正常是不影响移民的。
不过最近加拿大国内对乙肝的关注也越来越大,如果肝功不正常或者有肝硬化的迹象就会对移民申请产生不利影响。
乙肝携带者要注意自己的身体。
(2)移民体检项目加拿大移民体检项目和内容包括血,尿,胸透。
乙肝携带不影响申请,一般来说如果没有严重的疾病因为移民体检拒签的可能性不大。
(3)加拿大移民体检表当需要体检时,使馆会给您发一封体检通知信,内有体检表和相关说明,这就是体检表,体检表上注明了需要体检的项目和注意事项,申请者需要持体检表到相应医院找授权医生进行体检。
(4)加拿大移民体检授权医院及医生加拿大移民局会指定授权的医院和医生对您进行身体检查。
其他的医院和医生的体检结果无效。
(5)加拿大移民体检后移民体检的有效期是12个月,也就是说你应该在体检后的1年内登陆加拿大,否则这次体检将失效。
(6)加拿大体检医疗报告规程体检医疗报告和x-射线不会返回给体检者。
体检医生不会告诉您身体检查的结果。
最多医生只告诉你有一个健康问题。
扩展阅读:加拿大留学移民的政策加拿大是一个幅员辽阔的国家,地广人稀,国土面积高达997万平方公里,国家人口却只有3700多万。
对比我国国土面积960万平方公里,人口接近14亿来说就知道什么叫做天高任鸟飞,海阔任鱼游了。
加拿大虽然处于纬度较高的地区,但是人口和城市主要集中于国家纬度较低的10个省份,加上先进的取暖设施和除雪设施,使得加拿大的夏季不会太热,冬天也不会感到太冷,因此连续7年被评为“最适宜居住的国家”。
KB单词表
Aability [??bil?ti] n.能力activity centre / ?k?tiviti ?sent?/活动中心actor /??kt? / n.演员adventure / ?d?vent?? / 探险afraid* [??freid] adj.害怕的;担心的age [eid?] n.年龄all right* [?:l rait] 好,行,可以always* /??:lweiz/ adv.总是amphibians /?m?fibi:?nz/ n.两栖动物Antarctica /?n'tɑ:kt ik?/ 南极洲Arctic /?ɑ:kt ik / 北极arrest /??rest/ v.逮捕arrive [??ra?v] v.到达art photography /f?'t?gr?fi/ 艺术摄影atlas /??tl?s /地图册Australia [??strelj?] n.澳大利亚author / ??:θ? /n.作者average /'?v?rid?/ n.平均数awake* /??weik/ adj.醒着的Bbadly /?b?dli / adv.坏地,拙劣地bake /beik/ v.烤,烘焙balanced diet /?b?l?nst ?dai?t /均衡balloon /b??lu:n/ n.气球base /beis/ (棒球运动的)垒baseball field /?beisb?:l fi:ld / 棒球场basket /?bɑ:skit/n.篮子batter /?b?t? / n.击球员beat /bi:t/ v.打best* /best/ adj.最好的better* [?bet?(r)] adj.较好的blonde [bl?nd] adj.(头发)金色的blood /bl?d/ n.血液blood cell /sel/ 血细胞blood group /gru:p/ 血型bone /b?un/ n.骨头boring* /?b?:ri?/ adj.无聊的bottom [?b?t?m] n.底部adj.底部的bowl /b??l/ n.碗Brazil [br?'zil] n.巴西breathe /bri:e/ v.呼吸bring* / bri? / v.带来Britian / ?britin / 英国British / ?briti? / 英国的brochure / ?br?u?u? / 小册子bumblebee / ?b?mb?l?bi: / 大黄蜂busy* /?bizi/ adj.繁忙的button /?b?t?n / n.按钮buy* /bai/ 买by* /bai/ prep (表示交通方式)乘……Ccage [ke?d?] n.笼子calcium /?k?lsi?m/ n.钙Canada ['k?n?d?] n.加拿大capacity /k?'p?siti/ n.容量carbohydrate /?kɑ:b?u?ha idreit/ n.碳水化合物*careful /?ke?fl/ adj.认真的,仔细的*carefully /?ke?f?li/ adv.仔细地,小心地carry /'k?ri/ v.携带category /?k?t?ɡ?ri /n.种类,类别CD player* CD 播放机centiliter /'senti?li:t?/ 厘升centimeter /'senti?mi:t?/ 厘米cheese [t?i:z] n.奶酪cheetah /?t?i:t? / 非洲猎豹chest /t?est/ 胸chorus /?k?:r?s/ 合唱click [klik] v.使发出喀哒声climbing wall /?klaimi? w?:l/ 攀岩墙clown* [kla?n] n.丑角club [kl?b] n.俱乐部,coffee* [?k?:fi] n.咖啡compose / k?m?p?uz / n.作曲composer /k?m?p??z? / n.作曲家computer / k?m?pju:t? / n.计算机continent [?k?nt?n?nt] n.大陆could * / kud / 能够(can的过去式)couldn’t不能(can’t的过去式) crotchet [?kr?t??t] n.小钩cry* [kra?] v.哭泣cub /k?b/ 幼兽cup* [k?p] n.杯子caught /k?:t/ catch的过去式Dday [de?] n.白天dentist /?dentist/ n.牙医detective /di?tektiv/ n.侦探diameter [da???m?t?(r)] n.直径diary / ?dai?ri / n.日记DVD[?di: vi: ?di:] n.DVD光盘Eeach [i:t?] adj.每一个easily /?i:z?li/ adv.容易地easy* /?i:zi/ adj.容易的eighteenth [?e?'ti:nθ] num.第十八eighth / ei tθ/num.第八eighth notes ?八分音符eleventh [?'levnθ]num.第十一email ['i:me?l] n.电子邮件v.写电子邮件endangered /in?deind??d / adj.?濒危的energy /?en?d?i/ n.精力environment /in'vai?r?nm?nt/ n. 环境equipment / i?kwipm?nt/ n.设备erase / i?reiz / v.擦掉,抹去exciting* /ik?saiti?/ adj令人兴奋的excuse me [iks?kju:z mi:] 请原谅exhibition /? eksi?bi??n / n.展览expedition /?ekspi?di??n/ n.出行,远征explorer / ik?spl?:r? / n.探险者Ffall /f?:l/v.掉下famous [?fe?m?s] adj.着名的fan [f?n] n.扇子fat /f?t/ 脂肪few /?fju: / 有些,几个fifteenth [?f?f'ti:nθ]num.第十五fifth / fi fθ/num.第五finger [?f??g?(r)] n.手指fly* [flai] v.使飞;放飞fourteenth [?f?:'ti:nθ]num.第十四fourth* /f?:θ/num.第四fuel /fju?l/ n.燃料fun [f?n] n.乐趣lots of fun 许多乐趣Gget up 起床get dressed / dresd/ 穿上裙子glass [glɑ:s] n.玻璃杯a glass of 一杯ground [gra?nd] n.地面ground floor [graund fl?:] n.第一层Hhalf notes 二分音符happily /?h?pili / adv.高兴地have to* 不得不,必须health [helθ]n.健康health matters /helθ?m?t?z/关于健康hear [h??(r)] v.听见heart /hɑ:t/n.心脏help* [help] v.帮助hide* [ha?d] v.隐藏history [?h?stri] n.历史holiday [?h?l?de?] n.假日honey / ?h?ni / n.蜂蜜how [ha?] adv.多么int.怎样如何hum / h?m / v.哼(曲子)human body /'hju:m?n/人体Iice / ais / n.冰ill /il/ adj生病的in line 排队instruction [in?str?k??n] n.操作说明into /?intu / prep.到…里invite [?n?va?t] v.邀请in front of 在…前面JJapan [d??'p?n] n.日本Kkid /kid/ n.孩子kitten* /? kitn / n.小猫know /n?u/ v.知道Llandscapes /?l?ndskeips/ n.地形,地貌laugh [lɑ:f] v.笑layer [?le??(r)] n.层league / li:ɡ/n.协会learn to do 学做某事length /le?θ/n.长度less / les / adj.较少的let [let] v.让life / laif/ n.生活like /laik / prep.比如,例如line [la?n] n.队literature /?lit?rit??/ n.文学litre /?li:t?(r)/升loudly [la?dl?] adv.大声地lung / l??/ n.肺lots of fun 许多乐趣no time to lose 没时间可失去Mmake [me?k] v.做make mistakes / mis?teik /犯错mammals /?m?m?l /哺乳动物mass /m?s/ n物质mean* [mi:n] v.意味着measure /?me??(r)/ v.测量medal / ?med?l / n.奖牌medical /'medik?l/ check up 医疗检查method /'meθ?d/n.方法metre /'mi:t?(r)/ n.米millilitre /?milili:t?(r)/ n.毫升millimeter /'mili?mi:t?/ n.毫米mineral /?min?r?l/ n.矿物质mix / miks / v.混合modern / ?m?d?n / n.现代moon* / mu:n / n.月亮more /m?:/ adj.更多的most* /m?ust/ det.最pron.大多数人或物the most 最多的mouse /maus / n.鼠标Mozart /?m??tsɑ:t/莫扎特MP3 player / ?plei? / MP3播放机muscle /'m?sl/ n.肌肉music [?mju:z?k] n.音乐musical / ?mju:zik?l /音乐剧musical notes /?mju:zik?l /音符NNatural History Museum自然博物馆neck [nek] n.脖子Neverland /nev?l?nd/ 梦幻岛nineteenth [?na?n'ti:nθ]num.第十九ninth / nai nθ/num.第九Nobel prize / n?ubei ?praiz / 诺贝尔奖note [n??t] n. 钞票,纸币;音符nothing [?n?θ??] pron.没有东西novel /?n?v?l/ n.小说nutrients /?nju:tri?nts/ n.营养品Oo’clock/??kl?k/钟表ocean life海洋生物off [?f] prep. 从…向下;从…离开adv.……掉;……下oil / ?il / n.油Olympic Games /???limpik geimz/奥林匹克运动会open sea 公海out of 离开,脱离out of breath / breθ/喘不过气out of order 混乱over [???v?(r)] adj.结束的,完了的over the ground 在地面上over there 在那边owl /aul/ n.猫头鹰Ppasta* /?pɑ:st? /n.意大利面食pea-green青豆绿色的,黄绿色的perfectly / 'p?:fiktli/ adv.完美地,完善地photograph /?f?ut?ɡrɑ:f /照片photography /f?'t?gr?fi / n.摄影pirate* / ?pai?rit / n.海盗pitch /pit? / v.投,掷n.音高pitcher /?pit?? / n.投手play /plei/ n.戏剧play chess / plei t?es / 下象棋playtime /pleitaim/ n.游戏时间plenty of 很多plenty of money很多钱poem /?p?uim/ n.诗歌polar bear / ?p?ul? be? / 北极熊pop music 流行音乐pottery /?p?t?ri/ n.陶器preparation / ?prep??rei?n / n.准备present [?preznt] n.礼物; problem /?pr?bl?m / n.问题program /?pr?uɡr?m /n.程序protect / pr??tekt / v.保护protein /?pr?uti:n/ n.蛋白质puppy* [?p?pi] n.小狗,幼犬pussycat / ?pusik?t / n.猫咪Qquantity [?kw?nt?ti] n.数量quarter /?kw?:t?(r)/四分之一quarter notes 四分音符quaver /?kweiv? / ?颤音quickly /?kwikli/快地quietly* /?kwai?tli/安静地Rrabbit [?r?b?t] n.兔子real / ri?l / adj.真的realism /?ri:??liz?m / n.现实主义recipe /?res?pi/ n.食谱repairman / ri?pe?m?n / n.修理工reptiles /?reptailz/ n.爬行动物rhyme [ra?m] n.韵;押韵ride* [ra?d] n.搭乘rock climbing /r?k ?klaimi?/ 攀岩roller skating /?r?ul? ?skeiti?/ 滑旱冰round* / raund / adj.圆形的adv.在附近prep.围绕row / r?u / v.划船Ssack race 套袋跑sail* /seil/ v.航行salad* /'s?l?d/ n. 沙拉sandwich * [?s?nw?t?] n. 三明治sandwiches* /?s?nwit?s/ 三明治(复数)save / seiv / v.拯救screen /skri:n / n.屏幕sculpture /?sk?lpt?? / n.雕像sea creature /si: ?kri:t??(r)/ 海洋生物sea turtle /si: ?t?:tl / 海龟second /?sek?nd / adj.第二的adv.第二semi-breve /?semibri:v /全音符semi-quaver /?semi?kweiv? /十六分音符seventeenth [?sevn'ti:nθ]n.第十七seventh* [?sevnθ]num.第七shout [?a?t] v.大喊side /said/ n.边,面Sir Earnest Shackleton 欧内斯特-沙克尔顿爵士(英国南极探险家)sixteenth [?s?ks'ti:nθ]num.第十六sixth [s?ksθ] num.第六skate [ske?t] v.溜冰,滑冰n.溜冰鞋slow /sl??/ adj.慢的slowly* /?sl??li / adv.慢地snap /sn?p/ n.快照something* [?s?mθ??] n. 某事,某物sometimes /?s?mtaimz/ adv.有时*soup /su:p/ n.汤space [spe?s] n.太空Spain [spe?n] n.西班牙spider /?spaid? / n.蜘蛛square* [skwe?(r)] n.广场adj.方形的stomach [?st?m?k] n.胃strech /stret?/ v.伸展sugar /'?ug?/ n.糖surprised [s??pra?zd] adj.惊讶的swim / swim/ v.游泳swimmer / ?swim?(r)/ n.游泳者Ttake* [te?k] v.取;拿tall* [t?:l] adj.高的tandem /?t?nd?m / n.纵列二马拉的双轮马车tape measure /teip ?me??/卷尺tea* [ti:] n.茶teaspoon /?ti:?spu:n/ n. 茶匙tennis court /k?:t/ 网球场tenth* [tenθ] n.第十terrible* /?ter?bl/可怕的test /test/考试text [tekst] n.课文theatre / ?θi?t? /剧院third /θ?:d /adj.第三的adv.第三thirteenth [?θ?:'ti:nθ]num.第十三toothbrush [?tu:θbr??] n.牙刷treasure [?tre??(r)] n.宝藏treble clef 高音谱号trip [tr?p] n. 旅游turn on 打开twelfth / twelfθ/第十二twentieth / ?twenti:iθ/第二十Uup* [?p] adv. 向上prep. 在…之上Vvegetarian /?ved?i?te?ri:?n / n.素食者verse /v?:s/ n.歌词video* /?vidi?u / n.录像带v.制作……的录像带video clip / klip / ?录像片vital /'vaitl/ capacity 肺活量vitamin /?vit?min/ n.维生素volume /?v?lju:m/ n.卷,册Wwait* [we?t] v.等待walk* [w?:k] n.走water sports /?w?:t? sp?:ts /水上运动wear /we?(r)/ v.穿,戴whole notes 全音符work* /w?:k/ n.工作v.运转worst /w?:st/ adj.最坏的,最差的would* 将,将会wrap [r?p] v.包;wrapped up包好,裹住musical notes /?mju:zik?l /音符whole note 全音符half note 二分音符quarter note 四分音符eighth note ?八分音符semi-breve /?semibri:v /全音符semi-quaver /?semi?kweiv? /十六分音符quaver /?kweiv? / ?颤音treble clef 高音谱号C clef bass clef 低音谱号F clefa bowl of 一碗a bottle of 一瓶a cup of 一杯a glass of 一杯the best 最好的the worst 最坏的the most 最多的*slowly /?sl??li /慢地*carefully /?ke?f?li/仔细地,小心地badly /?b?dli /坏地,拙劣地*quietly /?kwai?tli/安静地easily /?i:z?li/容易地happily /?h?pili /高兴地sadlyget dressed / dresd/穿上裙子take off脱去put on穿上。
加拿大食品污染物监测数据库
“任何人不得将违反加拿大法令或这些法规的食品 进口加拿大进行销售。”
27
CFIA 全国微生物监测计划 (NMMP)
28
全国微生物监测计划 (NMMP) 的目的
• 提供关于在随机抽取的规定数量样品中存在的微生物
•
• •
•
病原体的信息。 对存在潜在问题区域的活动进行识别。 响应国际承诺。 如果发现违背,采取相应的管理措施以保护消费者。 提供数据,协助制定标准。
L. 、单核细胞 增生李斯特氏菌、S.奥里斯病菌、大肠杆菌 O157:H7
• 卫生指标,例如: 活性碳酸钙、大肠菌、排泄物中
的大肠菌、普通 E. 大肠菌 • 商业无菌性,容器完整性、PH值、水的活动、含盐量
31
2006/2007 年微量取样范围(续)
• 肉类 – 10项计划预计取2465个样品 。
• 奶制品和蜂蜜– 10项计划预计取1202个样品进行
分析 。
• 蛋 - 6项计划预计取1904个样品 。 • 新鲜水果和蔬菜 – • 加工产品 –
8项计划预计取680个样品 。
7项计划预计取167个样品 。
30
全国微生物监测计划 (NMMP) 的设计(续)
• 基于估测的风险进行优先级别的分级,例如:R-T-E
食品、某些产品的结合、食品带来疾病的爆发等等 。使用科学委员会程序来设定优先级别。 • 它们不用来提供关于违背率的高度准确的统计估测 值。不过,该计划准许对违规率进行统计估算。例 如, 如果在300 个被检测样品中没有查出违规,则 改批样本估计有95% 的置信度,违规率小于1 %。
法定采样
• 它是针对预期有后续诉讼的特定条件进行的采样。必
须符合所有质量保证。进行这些活动之前应首先征求 法律意见。
HealthCanada注册及分类
HealthCanada注册及分类Health Canada注册及分类加拿大医疗器械法规依据器械的使用风险将医疗器械分为I,II,III,IV四个分类,如I类器械为最低风险,IV类器械风险为最高。
为此针对制造者提出的医疗器械产品注册要求也是逐级增加,要求制造者实行的体系是愈加详尽。
I类医疗器械豁免注册。
II,III,IV类器械的注册要求如下:1.通用注册资料:a) 器械的名称;b) 器械的分类;c) 器械的标识;(奥咨达医疗器械服务)d) 产品标签上出现的制造者名称、地址;e) 若制造地点与d)不同,则制造地名称、地址;2.II 类器械注册附加资料:a) 所制造、销售或代理的器械关于医用条件的目的及用途的描述;b) 为满足安全和有效性要求所符合的标准的清单;c) 由制造者的高层主管作的安全有效性符合声明;d) 由制造者的高层主管作的器械标签符合加拿大医疗器械法规的声明;e) 若是近病人体外诊断设备(即不在医院而是在例如家庭使用的设备),制造者的高层主管应声明已用代表预期使用者的人体物质在与预期使用条件类似的条件下进行了研究性测试;f) 由CMDCAS认可机构颁发的CAN/CSA-ISO 13485-98体系证书。
3.III类器械注册的附加条件:a) 器械及在其制造及包装中所用材料的描述;b) 所制造、销售和代理的器械在其允许的医疗条件、目的和用途下的性能描述;c) 除加拿大外的器械获准销售的国家清单、售出数量,以及报导的问题及召回情况;(专注于医疗器械领域咨询)d) 器械的设计和制造为满足安全有效性而采用的标准清单;e) 如果是以无菌出售的器械,则无菌方法描述;f) 制造者为安全有效而进行的研究描述,以及由此得出的结论;g) 器械标签/复印件;h) 如果为近病人体外诊断设备,用代表目的预期用户的人体物质,以在使用条件类似的条件下的研究测试的情况;I) 所有与使用、安全和有效有关的公开发布的报告的文献引用;j) 由加拿大医疗器械认证机构认可的机构所颁发的CAN/CSA-ISO 13485:98证书。
2010年高考英语试卷(新课标Ⅱ)(含解析版)
2010年全国统一高考英语试卷(新课标Ⅱ卷)第二部分英语知识运用(共三节,满分50分)第一节语音知识(共5小题;每小题1分,满分5分)从A、B、C、D四个选项中,找出其划线部分与所给单词的划线部分读音相同的选项,并在答题卡上将该项涂黑.1. come( )A. coldB. cockC. comfortD. improve2. dead( )A. eagerB. greatC. leastD. health3. united( )A. useB. uglyC. upstairsD. put4. ours( )A. outsideB. cousingC. nervousD. clocks5. thirty( )A. theatreB. thusC. althoughD. feather第二节语法和词汇知识(共15小题;每小题1分,满分15分)从A、B、C、D四个选项中,选出可以填入空白处的最佳选项,并在答题卡上将选项涂黑。
6. --- Is it all right if I keep this photo?--- _______.A. No, you don’tB. No, it shouldn’tC. I’m afraid notD. Don’t keep it7. Tom was about to close the windows_____his attention was caught by a bird.A. whenB. ifC. andD. till8. My mother opened the drawer to _________ the knives and spoons.A. put awayB. put upC. put onD. put together9. Barbara is easy to recognize as she’s the only of the women who ____ evening dress.A. wearB. wearsC. has wormD. have worm10. --- Have you finished the book?--- No. I’ve read up to _____ the children discover the secret cave.A. whichB. whatC. thatD. where11. Though ______ to see us, the professor gave us a warm welcome.A. surpriseB. was surprisedC. surprisedD. being surprised12. Neither side is prepared to talk to _____ unless we can smooth thing over between them.A. othersB. the otherC. anotherD. one other13. The island is ____ attractive in spring and autumn because of the pleasant weather in both seasons.A. partlyB. merelyC. nearlyD. equally14. The doctor thought ____ would be good for you to have a holiday.A. thisB. thatC. oneD. it15. Linda, make sure the tables ____ before the guests arrive.A. be setB. setC. are setD. are setting16. I refuse to accept the blame for something _____ was someone else’s fault.A. whoB. thatC. asD. what17. I’m afraid Mr. Harding ____ see you now, he’s busy.A. can’tB. mustn’tC. shouldn’tD. needn’t18. --- Can I help you? Are you looking for anything in particular today?--- _____, we’re just looking.A. Yes, pleaseB. No, thank youC. Yes, you canD. No, you needn’t19. Excuse me, I I was blocking your way.A. didn’t realizeB. don’t realizeC. haven’t realizedD. wasn’t realizing20. Mr. Black is very happy because the clothes made in his factory have never been.A. popularB. more popularC. most popularD. the most popular第三节完形填空(共20小题;每小题1. 5分,满分30分)阅读下面短文,从短文后所给各题的四个选项(A、B、C和D)中,选出可以填入空白处的最佳选项,并在答题卡上将该项涂黑.A man who knows how to write a personal letter has a very powerful tool. A letter can be enjoyed, read and 21 . It can set up a warm conversation between two people far apart(远离的); it can keep a 22 with very little effort.I will give 23 . A few years ago my older brother and l were not getting 24 . We had been close as 25 but had grown apart. Our meetings were not 26 ; our conversation was filled with arguments and quarrels: and every effort to clear the air seemed to only 27 our misunderstanding. Then he 28 a small island in the Caribbean and we 29 touch. One day he wrote me a letter. He described his island and its people, told me what he was doing, said how he felt, and encouraged me to 30 . Rereading the letter, I was 31 by its humor(幽默)and clever expressions. These were all qualities for which I had 32 respected my older brother but 33 he no longer had them. I had never known he could write so 34 . And with that one letter we became friends 35 .It might never have occurred to 36 to write me if he had not been in a place where there were no 37 . For him, writing was a necessity. It also turned out to be the best way for us to get back in touch. Because we live in an age of 38 communication(通讯), people often 39 that they don’t always have to phone or email. They have a 40 . And that is to write.21. A. received B. rewritten C. returned D. reread22. A. record B. promise C. friendship D. secret23. A. an example B. a lesson C. an experience D. a talk24. A. through B. together C. along D. away25. A. brothers B. children C. fellows D. classmates26. A. normal B. necessary C. pleasant D. possible27. A. deepen B. start C. express D. settle28. A. toured B. stopped C. reached D. moved to29. A. lost B. kept in C. needed D. got in30. A. think B. write C. enjoy D. read31. A. driven B. beaten C. surprised D. honored32. A. never B. seldom C. sometimes D. once33. A. realized B. judged C. thought D. expected34. A. well B. often C. much D. soon35. A. later B. anyhow C. too D. again36. A. us B. anyone C. someone D. my brother37. A. mail services B. transport services C. phones D. relative38. A. poor B. easy C. popular D. busy39. A. believe B. decide C. argue D. forget40. A. habit B. choice C. method D. plan第二部分阅读理解(共2节,共25小题;第一节每小题2分,第二节每小题1分;满分45分)第一节(共20小题;每小题2分,满分40分)阅读下列短文,从每题所给的四个选项(A、B、C、D)中,选出最佳选项,并在答题卡上将该项涂黑.AWhen I was six, Dad brought home a dog one day, who was called “Brownie”. My brothers and I all loved Brownie and did different things with her. One of us would walk her, another would feed her, then there were baths, playing catch and many other games. Brownie, in return, loved each and every one of us. One thing that most touched my heart was that she would go to whoever was sick and just be with them. We always felt better when she was around.One days, as I was getting her food, she chewed up(咬破)one of Dad’s shoes, which had to be thrown away in the end. I knew Dad would be mad and I had to let her know what she did was Wrong. When I looked at her and said, “Bad girl. ” She looked down at the ground and then went and hid. I saw a tear in her eyes.Brownie turned out to be more than just our family pet. She went everywhere with us. People would stop and ask if they could pet her. Of course she’d let anyone pet her. She was just the most lovable dog. There were many dines when we’d be out walking and a small child would come over and pull on her hair. She never barked (吠)or tried to get away. Funny thing is she would smile. This frightened people because they thought she was showing her teeth. Far from the truth, she loved everyone.Now many years have passed since Brownie died of old age. I still miss the days when shewas with us.41. What would Brownie do when someone was ill in the family? A. Look at them sadly.B. Keep them company.C. Play games with them.D. Touch them gently.42. We can infer from Paragraph 2 that Brownie .A. would eat anything when hungryB. felt scary for her mistakeC. loved playing hide-and-seekD. disliked the author’s dad43. Why does the author say that Browrnie was more than just a family pet? A. She was treated as a member of the family.B. She played games with anyone she liked.C. She was loved by everybody she met.D. She went everywhere with the family.44. Some people got frightened by Brownie when she .A. smiledB. barkedC. rushed to thhemD. tried to be funny45. Which of the following best describes Brownie? A. Shy.B. Polite.C. Brave.D. Caring.BWhen you’re lying on the white sands of the Mexican Riviera, the stresses(压力)of the world seem a million miles away. Hey, stop! This is no vacation---yon have to finish something!Here lies the problem fat travel writer and food critic(评论家)Edie Jarolim. “I always loved traveling and always liked to eat, but it never occurred to me that I could make money doing both of those things. ” Jarolim said. Now you can read her travel advice everywhere --- in Arts and Antiques, in Brides, or in one of her three books. The Complete Idiot Travel Guide to Mexico’s Beach Resorts.Her job in travel writing began Some eight years ago. After getting a PhD in English in Canada, she took a test for Frommer’s travel guides, passed it, and got the job. After working at Frommer’s, Jarolim worked for a while at Rough Guides in London, then Fodor’s, where she fell so in love with a description of the Southwest of the U. S. that she moved there.Now as a travel writer, she spends one-third of her year on the road. The rest of the time is spent completing her tasks and writing reviews of restaurants at home in Tucson, Arizona.As adventurous as the job sounds, the hard part is fact --- checking all the information. Sure, it’s great to write about a tourist attraction, but you’d better get the local(当地的)museum hours correct or you could really ruin someone’s vacation.46. Which country does Jarolim have in now? A. Mexico.B. The U.S.C. The U.K.D. Canada.47. What is most difficult for Jarolim? A. Working in different places to collect information.B. Checking all the facts to be written in the guides.C. Finishing her work as soon as possible.D. Passing a test to write travel guides.48. What do we know about Jarolim from the text? A. She is successful in her job.B. She finds her life full of stresses.C. She spends half of her time traveling.D. She is especially interested in museums.49. What would be the best title for the text? A. Adventures in Travel WritingB. Working as a Food CriticC. Travel Guides on the MarketD. Vacationing for a LivingCThousands of people living in the Chinese capital will celebrate the start of the Chinese New year by heading for the ski resorts(滑雪场). Never mind that Beijing’s dry weather seldom produces snow. It is cold enough in winter for snow --- making machines to make a covering for the hills north to the capital. And the rapid growth of a pleasure --- seeking middle class has formed the basis for this new craze (热潮).Since Beijing’s first ski resort was opened ten years ago, the sport has enjoyed astonishing increase. There are now more than a dozen resorts. Clothes markets in the city have added bright colored ski suits to their winter collections. Mr. Wei, a manager of a newly-opened ski resort in Beijing, sees the growth of an industry that could soon lead Chinese to head for the ski resorts of Europe. In recent years ski resorts offering natural snow have opened in China. But many are in faraway areas of the country and can’t really match the equipment and services of some ski resorts in Europe.Beijing’s skiing craze is partly a result of the recent increase in private(私有的)cars. This has led to the growth of a leisure industry in the capital’s suburbs (郊区), which until the late-1990s were unreachable to ordinary people. According to Mr. Wei, about 40% of the visitors to his resort come in their own cars. The rest are bused in by schools, businesses or government offices.The problem is making money. Starting ski resorts requires quite a lot of money; hiring land from the local government, preparing the hills, buying snow machines, making sure there are enough water and electricity to run them, and buying ski equipment for hiring out to customers.The ski resort where Mr. Wei works cost nearly $4m to set up. And as so often in China when someone comes up with a good idea, many others hash in and price wars break out. Beijing now offers some of the cheapest ski training classes in the world, though with most people rather new to the sport, expecting a few more doing the samejob.50. What does this text mainly talk about? A. Convenience for skiers brought about by private cars.B. Skiing as a new way of enjoying one’s spare time.C. Things to be considered when starting a ski resort.D. A sudden increase of ski training classes in Beijing.51. Why are some Chinese likely to go skiing in Europe? A. To visit more ski areas.B. To ski on natural snow.C. For a large collection of ski suits.D. For better services and equipment.52. The underlined words “leisure industry” in Paragraph 3 refer to A. transport to ski resortsB. production of family carsC. business of providing spare time enjoymentsD part-time work for people living in the suburbs53. What is the main problem in running a ski resort? A. Difficulty in hiring land.B. Lack of business experience.C. Price wars with other ski resorts.D. Shortage of water and electricity.DCoolest Hotels in the WorldAriau Amazon TowersThe Ariau Amazon Towers hotel lets you sleep in a tree house. Eight towers make up this hotel that offers over 300 rooms. If you really want to get into the spirit, book the Tarzan Suite which is large enough for a big family. You’ll be thirty feet up in the air and can travel between the towers through their wooden walkways.Prices: starting at $300 one night for each person for a regular room and going all the way up to $3000 for the Tarzan Suite.For more information, visit the website: http: //The Ice HotelEvery winter in Jukkasjarvi, Sweden, a special kind of hotel called the Ice Hotelis built. Each year, world-famous artists are invited to design and produce works of art from the ice, many of which can be found in the rooms. You’ll have your choice between hot or cold rooms but you will be well advised to stay at least one night in a cold room for a true experience.Prices: starting at $318 one night for each person for either a cold room or a warm one. For more information, visit the website: http: // Propeller IslandPropeller Island City Lodge is a very special hotel that was designed by a German artist Each room provides you with the possibility of living in a work of art. Every single piece of furniture in the thirty rooms of the hotel has been hand-made and each room is completely different. You’ll be able to choose a room based on your own personal tastes.Prices: starting at just $91 a night, and an additional(另外)person for only 20 extra dollars. For more information, visit the website:http: //For information about other cool hotels in the world, visit the website:http: //54. What it special about the Ariau Amazon Towers hotel? A. You can sleep in tree houses.B. You can choose any of the towers.C. It is designed for big families.D. Every room has a walkway.55. For more persons spending a night in one of these hotels, they have to pay at least .A. $111B. $182C. $600D. $63656. Which website should you visit if you want to find out whether there exists a hotel under the sea? A. http: //B. http: //C. http: //D. htlp: //57. Which hotel would invite artists to come to work every year? A. Propeller Island City Lodge.B. Ariau Amazon Towers.C. The Ice Hotel.D. Bahama Beach Club.EHow words came into being is unknown. All we assume(推测)is that some early men invented certain sounds, in one way or another, to express thoughts and feelings, actions and things, so that they could talk with each other. Later they agreed upon certain signs, called letters, which could be put together to show those sounds, and which could be written down. Those sounds, whether spoken or written in letters, are called words.The power of words, then, lies in their associations---the things they bring up to our minds. Words become filled with meaning for us by experience; and the longer we tire, the more certain words bring back to us the happy and sad events of our past; and the more we read and learn, the more the number of words that mean something to us increases.Great writers are those who not only have great thoughts but also express these thoughts in words which have powerful effects on our minds and feelings. This clever use of words is what we call literary style(文体). Above all, the real poet is a master of words. He can express his meaning in words which sing like music, and which by their position and association can move men to tears. We should therefore learn to choose our words carefully and use them correctly, or they will make our speech silly and common.58. We learn from the text that language might have begun with .A. expressionsB. actionsC. signsD. sounds59. What is mainly discussed in Paragraph 2? A. The learning of new words.B. The importance of old wordsC. The relation of human experience with words.D. The gradual change and development of words.60. In the last paragraph, what does the author suggest that we should do? A. Use words skillfully.B. Make musical speechesC. Learn poems by heart.D. Associate with listeners.第二节(共5小题;每小题1分,满分5分)根据对话内容,从对话后的选项中选出能填入空白处的最佳选项,并在答题卡上将该项涂黑,选项中有两项为多余选项。
Lupolen HDPE 4261 AG 与 4261 AG BD 物理性能特性说明书
For Plastic Fuel Tank Systems / SCR Reservoir SystemsESCR = Environmental Stress Crack Resistance; FNCT = Full Notch Creep Test; BM = Blow Molding; TF = Thermoforming; IM = Injection Molding; SCR = Selective Catalytic ReductionYou can find out more about us by visiting our website at: Before using a product sold by a company of the LyondellBasell family of companies, users should make their own independent determination that the product is suitable for the intended use and can be used safely and legally. SELLER MAKES NO WARRANTY; EXPRESS OR IMPLIED (INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY WARRANTY) OTHER THAN AS SEPARATELY AGREED TO BY THE PARTIES IN A CONTRACT. This product(s) may not be used in: (i) any U.S. FDA Class I, Health Canada Class I, and/or European Union Class I Medical Devices, without prior notification to Seller for each specific product and application; or (ii) the manufacture of any of the following, without prior written approval by Seller for each specific product and application: (1) U.S. FDA Class II, Health Canada Class II or Class III, and/or European Union Class II Medical Devices; (2) film, overwrap and/or product packaging that is considered a part or component of one of the aforementioned Medical Devices; (3) packaging in direct contact with a pharmaceutical active ingredient and/or dosage form that is intended for inhalation, injection, intravenous, nasal, ophthalmic (eye), digestive, or topical (skin) administration; (4) tobacco related products andFor Plastic Fuel Tank Systems / SCR Reservoir Systems (Rotational Molding)ESCR = Environmental Stress Crack Resistance; FNCT = Full Notch Creep Test; SCR = Selective Catalytic ReductionYou can find out more about us by visiting our website at: Before using a product sold by a company of the LyondellBasell family of companies, users should make their own independent determination that the product is suitable for the intended use and can be used safely and legally. SELLER MAKES NO WARRANTY; EXPRESS OR IMPLIED (INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY WARRANTY) OTHER THAN AS SEPARATELY AGREED TO BY THE PARTIES IN A CONTRACT. This product(s) may not be used in: (i) any U.S. FDA Class I, Health Canada Class I, and/or European Union Class I Medical Devices, without prior notification to Seller for each specific product and application; or (ii) the manufacture of any of the following, without prior written approval by Seller for each specific product and application: (1) U.S. FDA Class II, Health Canada Class II or Class III, and/or European Union Class II Medical Devices; (2) film, overwrap and/or product packaging that is considered a part or component of one of the aforementioned Medical Devices; (3) packaging in direct contact with a pharmaceutical active ingredient and/or dosage form that is intended for inhalation, injection, intravenous, nasal, ophthalmic (eye), digestive, or topical (skin) administration; (4) tobacco related products and。
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Part B: Test Methods Section, Method F-23TEST METHOD FOR UTILITY LIGHTERS291SCOPE1.1This method describes procedures for testing utility lighters which use a gaseous fuel andare used for lighting fire places, barbeques, candles and gas stoves, etc. but not forcigarettes, cigars or pipes.1.2This method covers disposable and refillable utility lighters.1.3This method is based on Hazardous Products (Lighters) Regulations. While most tests aresame as in the Lighters Regulations, the Inversion Test and Extended Operations Testprocedures have been somewhat varied because of the end-use of utility lighters.1.4Utility lighters generally have an on/off switch. This switch is not considered a childresistance mechanism. A child resistance mechanism should function as defined in thelighters regulations.2APPLICABLE DOCUMENTS2.1Hazardous Products (Lighters) Regulations (see Appendix 3).2.2 Reference Manual Book 5, Part B, Method F-19: Test Method for Lighters.2.3Product Safety Reference Manual, Book 4 : Flammable Products.2.4Product Safety Laboratory Project Report # 2001-0629, Revision of Method F-23.3DEFINITIONS3.1Abnormal Burning Characteristics: See section 9 of the Lighters Regulations.3.2For other definitions, see section 2 (Interpretation) of the Lighters Regulations.3.3Afterburn: presence of a flame above the fuel orifice of a lighter after the normal action toextinguish the flame has been taken (see paragraph 8(f) of the Lighters Regulations).4APPARATUS4.1Flame Height and Inversion Tests4.1.1 A test box of a suitable size that is equipped with a steel ruler having 1 mmdivisions, vertically mounted on the rear wall of the box. A second ruler mountedat 45° or a scale drawn at 45° on the rear wall of the box with 10 mm divisions orPart B: Test Methods Section, Method F-23TEST METHOD FOR UTILITY LIGHTERS29 smaller. (The box provides for protection against air drafts which could affectflame-height measurements.)4.1.2 A set of wooden or aluminum blocks may or may not be required, depending onthe size of the lighter being tested, to serve as mounts to ensure that the lighterbeing tested is at the correct height relative to the zero division of the ruler.Alternatively, the ruler may be mounted such that it can be adjusted upwards ordownwards to accommodate the height of the lighter.4.1.3 A stopwatch capable of emitting a beep signal at 5 second intervals.4.1.4Stopwatch ( ±0.2 seconds), connected to a foot switch.4.2Drop Test4.2.1 A freezer that is capable of maintaining a temperature of &10±2°C.4.2.2 A concrete slab with a minimum mass of 55 kg and dimensions of at least 60 cm ×60 cm × 6 cm. See Appendix 2 for further specifications. The concrete slabshould be enclosed to contain flying debris; this can be accomplished bysurrounding it with a barrier which is at least 30 cm high.4.2.3An analytical balance.4.2.4Either a stopwatch (±0.2 second), or a computer linked to the balance. Thecomputer should have software capable of registering the mass at least once persecond while tracking the times when the mass registers within 0.1 second.4.3Temperature Test4.3.1An explosion-resistant, air-circulating oven that is capable of maintaining atemperature of 54±2°C.4.4Extended Operation Test4.4.1Stand and fixtures (e. g. clamps).4.4.2Safety shield.4.4.3 A stopwatch (± 1 second).4.5Pressure Test4.5.1 A bench-top drill and a 3.06 mm (1/8") drill bit.Part B: Test Methods Section, Method F-23TEST METHOD FOR UTILITY LIGHTERS294.5.2 A device that is capable of producing an internal gauge pressure of 2 MPa (Figure1) equipped with a manometer capable of measuring the pressure to the nearestkPa.4.5.3 A cylinder of nitrogen gas.4.5.4An unbreakable container (metal or plastic) of approximately 4 L capacity.4.5.5 A stopwatch (± 1 second).5TEST PROCEDURES5.1General5.1.1Record product characteristics such as adjustable or nonadjustable, disposable orrefillable, child resistance, lot number etc. Record any inscriptions/identitymarks/writings on the body of the lighter.5.1.2Verify and record that all the lighters in the sample have the same lot number. Ifthere is no identifiable lot number then the sample is treated as one lot.5.1.3Number each lighter in the sample (50 lighters). In the case of disposable lighters,make note of any lighter that is empty. Replace empty lighters with filled ones ifany spares are available (i.e. if more lighters than the number required in section 9were received).5.1.4Remove a label from one of the lighters and attach it to the record sheet. If thelighter is adjustable, record whether the product complies with section 5 of theLighters Regulations. If the lighter is refillable, record whether the product wasaccompanied by refuelling instructions. If so, retain one of the instruction sheetsfor the records.5.1.5Follow the procedures in sections 1 to 4 of the Schedule to the LightersRegulations as applicable to gas lighters only, i.e. ignore reference to sections 11and 12.5.1.6Any lighter that, during testing, is perceived to present a hazard to the analyst shallbe immediately withdrawn from testing. Record having done so and the reasonwhy.5.1.7If a lighter runs out of fuel during testing, it will be re-fuelled if it is a refillable typeexcept after the Temperature Test.5.1.8As a safety measure, if the lighter fails to light after 4-5 attempts, it will be carefullydismantled to see if the tubing connections to the fuel reservoir are intact. If thePart B: Test Methods Section, Method F-23TEST METHOD FOR UTILITY LIGHTERS29 gas tube is dislodged, the lighter will be pulled from testing because such a lighteris considered hazardous for the analyst to test. Record this information.5.1.9Record any incident of fuel leakage and, if possible, indicate the location of theleak.Part B: Test Methods Section, Method F-23TEST METHOD FOR UTILITY LIGHTERS29Part B: Test Methods Section, Method F-23TEST METHOD FOR UTILITY LIGHTERS295.2Child Resistance (CR) Mechanism Test5.2.1Without unlocking the CR mechanism, attempt to light each lighter at least threetimes and make note of the lighters that light. Lighters that have only an on-offswitch are not subjected to this test.5.3Flame Height Tests5.3.1Stand the lighter vertically on the mount in the test box, ensuring that the end ofthe barrel is aligned with the zero on the vertical ruler.5.3.2Test the lighters according to the procedures of section 5 (a), (b), (e) and (f) of theSchedule to the Lighters Regulations and record:(i) all flame heights(ii) flame height ranges (fluctuations) for lighters that show sudden increase inflame height(iii) duration of afterburn(iv) any abnormal burning characteristics(v) any occurrence of the CR mechanism not resetting automatically after a test.5.3.3The five-second beep interval of the stopwatch is used to time the flame heightmeasurements.5.3.4Use the stopwatch connected to the foot switch to measure any afterburn thatoccurs.5.4Inversion Test5.4.1The Inversion Test on each lighter is conducted immediately after its flame heighttests. If the lighter is adjustable, set the flame height to maximum, light the lighterand adjust the flame height to 50 mm. If, during this flame height adjustment step,the flame height at maximum is significantly different from the one recorded in 5.3,record it. The same applies for any other abnormal burning characteristics. Holdthe lighter with its barrel rotated downward at 45/ below the horizontal and light it.Let the lighter burn for 10 s and then record:(i) flame fluctuation ranges for lighters that show sudden increase in flame lengths(ii) duration of afterburn(iii) any abnormal burning characteristics(iv) any occurrence of the CR mechanism not resetting automatically after the test(during the whole test, the lighter is kept in the inverted orientation).Part B: Test Methods Section, Method F-23TEST METHOD FOR UTILITY LIGHTERS295.5Drop Test5.5.1Test the lighters according to section 8 of the Schedule to the LightersRegulations. The three drops are, in order: (i) Vertical drop with the barrel pointingupwards; (ii) Vertical drop with the barrel pointing downwards, (inverted drop) and(iii) Horizontal drop.5.5.2If the concrete slab has a border around its top surface, drop the lighters on themiddle area of the slab only.5.5.3After each of the first two drops, check, by listening (the hissing sound) or feeling(cooling effect due to evaporation of fuel) if the lighter is leaking. If a leak isdetected, place the lighter on an analytical balance and record the mass loss inmilligrams over a period of one minute. After the third drop, even if no leak isapparent, place the lighter on the balance for a minimum of 10 seconds. If a leakis detected, measure the mass loss in milligrams over a period of one minute.5.5.4If a lighter loses the major part of its fuel on impact, an attempt to measure therate of fuel loss can still be made as above. However, if this results in a rate offuel loss of less than 15 mg/min, it should be recorded and reported that the lighterlost all fuel on impact. In the case where the raw data from the balance iscollected by a computer, it is also possible to evaluate the rate of fuel loss from thefirst five seconds (for example) that the lighter was on the balance.5.6Temperature Test5.6.1Test the lighters according to section 9 of the Schedule to the LightersRegulations.5.6.2The fuel status in the lighter is examined by any means, i.e. looking through thelighter casing or, if the casing is opaque, by activating the fuel-release lever andlistening to the hissing sound due to escaping fuel or by attempting to light thelighter. As a last resort, in the case of an opaque casing, a hole can be drilled inthe fuel reservoir while listening for gas escaping.5.7Extended Operation Test5.7.1Perform the test according to the procedures in section 7 of the Schedule to theLighters Regulations except that the lighter is tested while being held with its barrelrotated downward at 45/ below the horizontal.5.7.2Set up a lighter behind a safety shield, unlock the CR mechanism, depress the gasrelease lever, light the lighter and let it burn for two minutes. Record any of theburning characteristics given in section 16 of the Lighters Regulations and if theburning occurs at places other than at the end of the lighter barrel.Part B: Test Methods Section, Method F-23TEST METHOD FOR UTILITY LIGHTERS295.8Pressure Test5.8.1Perform the test according to the procedures of section 10 of the Schedule to theLighters Regulations except that the test will be done on the fuel reservoirs takenout of the lighters.5.8.2Empty the lighters of the fuel in a fume hood by unlocking the CR mechanism andtaping down the fuel release lever.5.8.3Take out the fuel reservoirs by dismantling the lighters and identify the fuelreservoir with the same number as on the lighter. Drill a hole in the broad side ofthe fuel reservoir while avoiding any partition.5.8.4Install a fuel reservoir into the pressure test device (see Figure 1) and immerse theassembly under water in the unbreakable container. Note: it is important tominimize the length and diameter of the tubing attached to the lighter in order toreduce as much as possible the bias on the results this tubing will introduce.5.8.5Pressurize the lighter with nitrogen at a rate not exceeding 150 kPa/s to a pressureof 1500 kPa and shut off the gas supply. (If at any time, i.e. during or afterpressurizing, a leak is observed around the drill-hole, depressurize the assembly,tighten the clamp device a little more and try to re-pressurize).5.8.6Record the internal pressure of the lighter after one minute and make note of thelocation of leakage. Note: if it is suspected that a major structural failure (i.e. thelighter breaks apart) occurred due to the lighter being drilled, or from the clampingpressure, the results are not valid. A replacement lighter must then be tested.6QUALITY ASSURANCE/QUALITY CONTROL PROCEDURES6.1Flame height measurements must be conducted in a draft free area (see F-00) undersubdued lighting conditions.6.2Conditioning and testing are to be done at 23±2°C.7TEST REPORT7.1The test report should contain the following information (see Appendix 1 for a model testreport):7.1.1Description of the lighters (either in the body of the report or in the header).7.1.2 A scanned image of the label(s), and instructions for refuelling the lighter (in thecase of refillable lighters).Part B: Test Methods Section, Method F-23TEST METHOD FOR UTILITY LIGHTERS297.1.3For each lighter, report the test results that do not meet the requirements (as perthe H.P. (Lighters) Regulations) for the following tests:7.1.4CR Mechanism Test;7.1.5Flame Height Tests;7.1.6Inversion Tests;7.1.7Drop Test (also report the orientation in which the lighter was dropped);7.1.8Temperature Test;Test;7.1.9 Pressure7.1.10Extended Operation Test, including burning that occurs in a place other than theend of the lighter barrel.7.2Also report:7.2.1Dislodging of gas tube from its fuel reservoir or any other damage to the tube;7.2.2Any incident of fuel leakage during testing and indicate the location of the leak, ifpossible; and7.2.3The removal of any other lighter from testing and the reason for its removal.8PRECISION AND BIASA statement on precision cannot be made due to the destructive nature of the tests.A statement on bias cannot be made because the true values of the measured parameters are notknown.9SAMPLINGA typical sample consists of 50 sample elements. However, a sample can still be tested if thenumber of lighters received is less than 50. All sample elements are taken from the same lot.Part B: Test Methods Section, Method F-23TEST METHOD FOR UTILITY LIGHTERS29Figure 1: Pressure Test DevicePart B: Test Methods Section, Method F-23 TEST METHOD FOR UTILITY LIGHTERS29APPENDIX 1Standard Report Format - Utility LightersMethod Used: F23Inscription(s) on product: noneLabel(s)on product: (not to scale)(Scan of packaging on last page)Initial TestsCR Mechanism Test#15lit without unlocking the CR mechanism.#37failed to reset itself after every useFlame Height and Inversion TestsThe following table lists only those lighters that exhibited some type of defects.Lighter#Flame Height (mm)Inversion Maximum Abnormal Burning Minimum AbnormalBurningFlameHeight (mm)AbnormalBurning 4160-230 3.5 s afterburn35>30 s afterburnâ6110-190 ã 3.0 s afterburn35 1.1 s afterburn 7120-1609.3 s afterburn25 5.4 s afterburn 8190-2307.2 s afterburn40 1.6 s afterburn 915090-11016.4 s afterburn 11200> 30 s afterburn ä1319010.2 s afterburn40 5.4 s afterburn 14110-25020199025 å32130-22035.9 s afterburn20piezo stopped working3310045 3.7 s afterburnPart B: Test Methods Section, Method F-23TEST METHOD FOR UTILITY LIGHTERS29Lighter#Flame Height (mm)Inversion Maximum Abnormal Burning Minimum AbnormalBurningFlameHeight (mm)AbnormalBurning35100-14030 4.0 s afterburn 38æ45140-22010.3 s afterburn30 4.8 s afterburn 4670258.6 s afterburn 48110çâThe trigger stuck in the open position and the lighter continued to burn. The trigger had to be forced out to shut off the lighter.ãWould not light at maximum setting - had to be lit at minimum setting and then increased to maximum.äFuel release stuck in open position - testing discontinued.åLeaked fuel at valve unit of fuel reservoir, then stopped, while setting to minimum.æLeaked fuel at valve unit of fuel reservoir while setting to maximum - testing discontinued.çLeaked fuel at valve unit of fuel reservoir while setting to minimum - testing discontinued.Drop TestLighters numbered from 1 to 25 (excluding #11) were subjected to the Drop Test. No fuel loss defectswere observed.In these utility lighters there is a plastic tube that carries fuel from the nozzle of the fuel reservoir to the nozzle at the end of the barrel. The tube in some lighters can become disconnected from the nozzle at the reservoir end thus causing the fuel to be released into the body of the lighter rather than out the end of the barrel. This problem is usually discovered during the Flame Height Tests which follow the Drop Test. The tube was disconnected in the following 15 lighters:2, 3, 6, 8, 10, 12, 13, 15, 16, 17, 18, 20, 21, 23 and 25In addition, the tube in lighter #1 became disconnected during flame height testing.CR Mechanism TestThe requirements were met.Flame Height and Inversion Tests (after the Drop Test)The following table lists only those lighters that exhibited some type of defects.Part B: Test Methods Section, Method F-23TEST METHOD FOR UTILITY LIGHTERS29Lighter#Flame Height (mm)Inversion Maximum Abnormal Burning Minimum AbnormalBurningFlameHeight (mm)AbnormalBurning4140-17010.0 s afterburn30 1.3 s afterburn 7120-230 3.7 s afterburn20 1.3 s afterburn 9è14130->267*20* 267 mm is the top of the test box.èLeaked fuel at valve unit of fuel reservoir while setting to maximum - testing discontinued.Temperature TestLighters numbered from 26 to 50 (except #32, #38 and #48) were subjected to the Temperature Test. Lighter #31 was completely exhausted of fuel.CR Mechanism TestThe requirements were met.Flame Height and Inversion Tests (after the Temperature Test)The following table lists only those lighters that exhibited some type of defects.Lighter#Flame Height (mm)Inversion Maximum Abnormal Burning Minimum AbnormalBurningFlameHeight (mm)AbnormalBurning26160-210 2.4 s afterburn3528200->267* 6.7 s afterburn4029130-180 6.6 s afterburn40 1.4 s afterburn 30150-190 2.9 s afterburn4033110-17050 1.2 s afterburnPart B: Test Methods Section, Method F-23TEST METHOD FOR UTILITY LIGHTERS29Lighter#Flame Height (mm)Inversion Maximum Abnormal Burning Minimum AbnormalBurningFlameHeight (mm)AbnormalBurning34150-2103035130-2203036130-210 5.2 s afterburn30 3.2 s afterburn 37é394020110 3.8 s afterburn ê* 267 mm is the top of the test box.éLeaked fuel at valve unit of fuel reservoir while setting to maximum - testing discontinued.êLeaking fuel after test - testing discontinued.Extended Operation TestEleven lighters were subjected to the Extended Operation Test. The following defects were observed: # 7ignition took place half way up the barrel along the seam - testing discontinued#40ignition of component parts#50ignition of component partsPressure TestSixteen lighters were subjected to the Pressure Test. The following lighters exhibited drops in internal pressure in excess of 250 kPa/min:# 5278kPa/min#27974kPa/minPart B: Test Methods Section, Method F-23TEST METHOD FOR UTILITY LIGHTERS29APPENDIX 2Specifications for concrete used in drop testNote: The following directions mention dimensions for the frame into which the concrete mixture is poured. These dimensions are only one of many possibilities. The only restrictions on the dimensions of the final product are: minimum width and length of 60 cm, a minimum thickness of 6 cm and a minimum mass of 55 kg. The final product should have a middle area having a uniform texture measuring at least 60 cm × 60 cm, so care should be taken not to make the outside edge too wide (steps C-5 and C-8, below). The texture should not be too smooth, approximating that of a common sidewalk.Glossary Of TermsSegregation- The separation of coarse aggregates from the mortar or the water from the ingredients. Straight Edge- A 2” × 4” wood or similar shaped object with a straight side used to level/flatten the excess concrete from the surface after placement.Concrete Mixture DataComponentsApproximate quantities for producing1 cubic metre of fresh concreteAggregate Size- 20 mm1178 kgWashed Concrete Sand830 kgPortland Cement- Type 10300 kgPotable Water116 kgStrength & Mixture30 Mpa (Mega Pascals)6-8% Air Entrainment75 mm SlumpConstruction of Concrete SlabsA. Tools & MaterialsTools: Hammer, Hand Saw, Square, Pencil, Shovel, 12” Steel Rod, Concrete Vibrator (if available) Materials: Half Sheet ¾” Plywood, 12’ 2” × 4” Stock, 3” & 2” Common Nails (12 each)B. Form Preparation1. Using a three-quarter inch thick sheet of plywood, cut a rectangle having dimensions 28” × 28” (71 cm ×71 cm).Part B: Test Methods Section, Method F-23TEST METHOD FOR UTILITY LIGHTERS292. Using 2” × 4” lumber, create a rectangular frame having outside dimensions 28” × 28” with the lumber standing on its narrowest side. Corners should be fastened into one another using 3” common nails.3. With the 2” × 4” frame complete, place it over the plywood cut-out. Align the two units with each other then flip the entire box frame over and place it onto a flat hard surface. Fasten the plywood to the 2” × 4”frame using 2” common nails.4. Once the box frame is secured flip the unit over and place it on a level flat surface.C. Concrete Placement1. Place concrete mixture (as per specifications) into box frame using a shovel or similar handling device. Care should be taken to avoid segregation of the mixture when placing into the form.2. Once the box frame has been filled, consolidate the concrete into the corners and edges using a steel rod or concrete vibrator.3. Place a straight edge (2” × 4” or equivalent) over the box frame resting over two opposite sides. Starting from one side work the straight edge over the concrete keeping it flat on the box frame edges.4. Once the excess concrete has been stricken off the surface use a wooden float to further consolidate any openings on the surface. The wooden float should be worked back across the surface area in a flat circular motion.5. Use a concrete edging tool to create a smooth outside surface along the perimeter of the form. Once complete allow concrete to set until surface has stiffened. Note: Time required will vary depending on air temperature. Higher temperatures increase setting time. Concrete should be checked every 20 minutes for workability.6. Using an aluminum magnesium trowel, work the concrete surface in both directions to fill any small air pockets/voids until the surface is smooth.7. With a smooth bristle broom create an even line pattern across the slab by pulling the broom in a backward direction.8. Complete concrete finish by repeating step # 5.9. After allowing to set for a 48 hour period, gently remove form work by extracting the nails.Part B: Test Methods Section, Method F-23TEST METHOD FOR UTILITY LIGHTERS29APPENDIX 3Hazardous Products (Lighters) Regulations1SOR/89-514P.C. 1989-2151 26 October, 1989Her Excellency the Governor General in Council, on the recommendation of the Minister of Consumer and Corporate Affairs, pursuant to section 5* of the Hazardous Products Act, is pleased hereby to revoke the Hazardous Products (Lighters) Regulations, made by Order in Council P.C. 1979-3095 of November 15, 1979**, and to make the annexed Regulations respecting the advertising, sale and importation of hazardous products (lighters), in substitution therefor.* R.S., c. 24 (3rd Supp.), s. 1** SOR/79-843, 1979 Canada Gazette Part II, p. 4318REGULATIONS RESPECTING THE ADVERTISING, SALE AND IMPORTATION OF HAZARDOUSPRODUCTS (LIGHTERS)Short Title1. These Regulations may be cited as the Hazardous Products (Lighters) Regulations.Interpretation2. In these Regulations,"gas lighter" means a product utilizing as fuel liquefied hydrocarbons, such as n-butane and isobutane, with a vapour pressure at 24/C that exceeds a gauge pressure of 100 kPa; (briquet à gaz)"luxury lighter" means a product that is designed to be refilled with fuel and that has, where the product is manufactured in Canada, a value of greater than $2.50 on sale by the manufacturer and, where the product is imported into Canada, a value for duty of greater than $2.50 as determined in accordance with section 46 of the Customs Act; (briquet de luxe)"product" means a lighter included in item 34 of Part II of Schedule I to the Hazardous Products Act; (produit) "production lot" means a group of substantially identical products manufactured by the same manufacturer under substantially identical conditions; (lot de production)1This consolidation is prepared for convenience only. For all purposes of interpreting and applying the law, users should consult the regulations, as registered by the Clerk of the PrivyCouncil and published in Part II of the Canada Gazette.Part B: Test Methods Section, Method F-23TEST METHOD FOR UTILITY LIGHTERS29 "shield" means a structure that totally or partially surrounds the fuel orifice of a product and projects beyond it;(écran de protection)"spitting" means an escape of liquid fuel that produces a shower of burning droplets which separate from the main flame; (crachotement)"successful operation" means the emission of an audible or visual signal, when a surrogate lighter is being tested;(actionner)"surrogate lighter" means a device used for testing purposes that(a) approximates the appearance, size and weight of the product that it represents,(b) is, within reasonable manufacturing tolerances, identical to the product that it represents in all factors thataffect child-resistance, including the operation and force or forces required for operation,(c) has no fuel, and(d) produces a clearly discernible audible or visual signal instead of a flame. (briquet de substitution)"wick lighter" means a product utilizing as fuel liquid hydrocarbons, such as hexane, with a vapour pressure at 24/C that does not exceed a gauge pressure of 34 kPa. (briquet à essence) SOR/91-261, s. 1; SOR/95-252, s. 1.General3. A product may be advertised, sold or imported if the product meets the requirements of these Regulations.Luxury Lighter Records3.1 Any person who manufactures or imports a luxury lighter shall, for a period of six years beginning on the date of sale by the manufacturer or the date of importation, as the case may be, maintain records that identify the luxury lighter and that show(a) in the case of a luxury lighter manufactured in Canada, the value on sale by the manufacturer; and(b) in the case of an imported luxury lighter, the value for duty as determined in accordance with section 46 ofthe Customs Act. SOR/95-252, s. 2.Compliance Certificate3.2 The manufacturer and the importer of a product other than a luxury lighter shall(a) possess a certificate that states in English or French that the surrogate lighter of the product has been testedand complies with the requirements set out in subsection 7.1(2) for child-resistance and(i) the name and address of the person who issued the certificate;(ii) the name and address of the manufacturer of the product, and(iii) the name and model of the product;(b) keep a copy of the certificate for three years beginning on the date of manufacture or importation of theproduct, as the case may be; and。