ISO 8362-6-2010 注射容器及附件.注射小瓶用铝塑组合盖
玻璃管制注射剂瓶标准
玻璃管制注射剂瓶标准玻璃管制注射剂瓶作为药品包装材料，是具有重要安全性要求的。
相关标准主要包括国际标准、国家标准和行业标准。
以下是关于玻璃管制注射剂瓶标准的参考内容：国际标准：1. ISO 8362-1：该标准规定了注射用玻璃制品的外形尺寸、内径、摄氏度和结构要求等方面的要求，确保玻璃瓶的质量和安全性。
2. ISO 8362-2：该标准针对玻璃瓶的接口设计与尺寸进行了规范，以确保瓶盖和其他连接件的配合质量，并确保药品的密封性能。
3. ISO 8536-1：该标准规定了瓶塞和注射器连接接口的要求，确保玻璃瓶与注射器之间的联接紧固牢固，以保证注射过程中瓶塞不会脱落。
4. ISO 80369-7：该标准针对药品成分易互相混淆的问题，规定了玻璃管制注射剂瓶的颜色标识要求，以确保药物的正确使用，并防止误用和交叉感染。
国家标准：1. GB 2637-94：该标准规定了玻璃管注射剂瓶的物理、机械性能要求，如瓶身、底部和瓶口的厚度、硬度、耐压强度等指标，以确保瓶身的强度和质量。
2. YY 0337：该标准规定了注射用玻璃瓶的外形尺寸、瓶塞的要求、瓶塞与注射器的连接等方面的要求，以确保药品的密封性和注射过程的顺利进行。
行业标准：1. YBB00172003-2015：该标准规定了药品玻璃瓶的生产工艺、质量分级、检测方法等内容，确保生产过程的规范性和产品的质量稳定性。
2. YBB00112006-2015：该标准规定了玻璃管制注射剂瓶的物理性能、化学性能、透明性等关键指标，以确保瓶身对药品的保护性能。
此外，国内还有一些地方标准和企业标准，用于针对特定行业或特定产品的要求，确保玻璃管制注射剂瓶在具体应用中的安全性和稳定性。
这些标准的制定和遵循有助于保障药品质量和患者用药的安全性。
对于玻璃管制注射剂瓶的设计、制造、包装和使用过程中，需要参考和遵循相关标准，并采取相应的质量控制措施。
药品包装材料与药物相容性试验指导原则
药品包装材料与药物相容性试验指导原则----40f5b4ba-6ebb-11ec-a06a-7cb59b590d7d来源国家药品监督管理局发布时间:2021-10-23ybb00142002药品包装材料与药物相容性试验是指为考察药品包装材料与药物之间是否发生迁移或吸附等现象，进而影响药物质量而进行的一种试验。
由于包装材料众多、包装容器的各异及被包装制剂的不同，为方便、有效地进行本试验，特制定本指导原则。
一、相容性试验测试方法的建立在考察药品包装材料时，应选用三批包装材料制成的容器对拟包装的一批药品进行相容性试验：考察药品时，应选用三批药物用拟上市包装的一批材料或容器包装后进行相容性试验。
当进行药品包装材料与药物的相容性试验时，可参照药物及该包装材料或容器的质量标准，建立测试方法。
必要时，进行方法学的研究。
二、相容性试验的条件1.用深色或深色包装材料或容器包装的药品，应进行强光照射试验。
将试验对象放置在装有荧光灯或其他合适照明设备的灯箱中10天，进行辐照试验。
将试验对象放置在装有荧光灯或其他合适照明设备的灯箱中10天。
照明条件为4500lx±5001x。
第5天和第10天取样，根据重点调查项目进行检测。
2.在加速试验中，将试验对象置于温度为40℃±2℃，相对湿度为90%±10%或20%±5%的恒温恒湿箱中，放置6个月，分别在0、1、2、3和6个月取出进行检测。
温度敏感药物可在25℃±2℃和60%±10%相对湿度下测试6个月。
它用于预测包装对药物保护的有效性，并推测药物的有效期。
3.长期试验时，将试验对象置于温度为25℃±2℃，相对湿度为60%±10%的恒温恒湿箱中，放置12个月，分别于0、3、6、9、12个月取出检测。
12个月后，仍需按照相关规定继续调查，分别在18、24和36个月内取出进行检测，以确定包装对药品有效期的影响。
ISO 8362-2-2008 注射容器及附件.注射小瓶用瓶塞
Reference number ISO 8362-2:2008(E)© ISO 2008INTERNATIONAL STANDARD ISO 8362-2Second edition 2008-10-15Injection containers and accessories — Part 2:Closures for injection vialsRécipients et accessoires pour produits injectables — Partie 2: Bouchons pour flaconsCopyright International Organization for Standardization Provided by IHS under license with ISONo reproduction or networking permitted without license from IHS--`,,```,,,,````-`-`,,`,,`,`,,`---ISO 8362-2:2008(E)PDF disclaimerThis PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area.Adobe is a trademark of Adobe Systems Incorporated.Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.COPYRIGHT PROTECTED DOCUMENT© ISO 2008All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright officeCase postale 56 • CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyright@ Web Published in Switzerlandii© ISO 2008 – All rights reservedCopyright International Organization for Standardization Provided by IHS under license with ISONot for ResaleNo reproduction or networking permitted without license from IHS--`,,```,,,,````-`-`,,`,,`,`,,`---ISO 8362-2:2008(E)© ISO 2008 – All rights reservediiiForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 8362-2 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use .This second edition cancels and replaces the first edition (ISO 8362-2:1988) which has been technically revised in order to align this part with ISO 8871-1, ISO 8871-4 and ISO 8871-5.ISO 8362 consists of the following parts, under the general title Injection containers and accessories : ⎯ Part 1: Injection vials made of glass tubing ⎯ Part 2: Closures for injection vials ⎯ Part 3: Aluminium caps for injection vials ⎯ Part 4: Injection vials made of moulded glass ⎯ Part 5: Freeze drying closures for injection vials⎯ Part 6: Caps made of aluminium-plastics combinations for injection vials⎯ Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics partCopyright International Organization for Standardization Provided by IHS under license with ISONot for ResaleNo reproduction or networking permitted without license from IHS--`,,```,,,,````-`-`,,`,,`,`,,`---ISO 8362-2:2008(E)iv© ISO 2008 – All rights reservedIntroductionThe purpose of this part of ISO 8362 is to specify the shape and dimensions of, and the requirements for, elastomeric closures intended for pharmaceutical use. Closures made from elastomeric materials are suitable primary packaging materials for parenteral preparations. In order to provide seal integrity of the container closure systems the dimensions of the elastomeric closures have to be compatible with the dimensions of the glass vials and the caps as specified in corresponding parts of ISO 8362.Primary packaging components made of elastomeric materials are an integral part of medicinal products and thus the principles of current Good Manufacturing Practices (cGMP) apply to the manufacturing of these components.Principles of cGMP are described in, for example, ISO 15378 or GMP Guidelines as published by the European Community and the United States of America.Copyright International Organization for Standardization Provided by IHS under license with ISONot for ResaleNo reproduction or networking permitted without license from IHS--`,,```,,,,````-`-`,,`,,`,`,,`---INTERNATIONAL STANDARD ISO 8362-2:2008(E)© ISO 2008 – All rights reserved1Injection containers and accessories — Part 2:Closures for injection vials1 ScopeThis part of ISO 8362 specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362-1 and ISO 8362-4. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this part of ISO 8362 are intended for single use only.NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 48, Rubber, vulcanized or thermoplastic — Determination of hardness (hardness between 10 IRHD and 100 IRHD)ISO 3302-1, Rubber — Tolerances for products — Part 1: Dimensional tolerancesISO 3302-2, Rubber — Tolerances for products — Part 2: Geometrical tolerancesISO 7619-1, Rubber, vulcanized or thermoplastic — Determination of indentation hardness — Part 1: Durometer method (Shore hardness)ISO 8871-1, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavatesISO 8871-4, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 4: Biological requirements and test methodsISO 8871-5:2005, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing3 ClassificationClosures for injection vials shall be classified as follows:⎯ Type A: closures for injection vials without no-pop/blow-back feature. ⎯ Type B: closures for injection vials with no-pop/blow-back feature.Copyright International Organization for Standardization Provided by IHS under license with ISONot for ResaleNo reproduction or networking permitted without license from IHS--`,,```,,,,````-`-`,,`,,`,`,,`---ISO 8362-2:2008(E)2© ISO 2008 – All rights reserved4 Shape and dimensions4.1 The shape and dimensions of closures shall be as shown in Figure 1 and as given in Table 1. Figure 1 illustrates two types of closures, Types A and B.Dimensions in millimetresa) Type Ab) Type BKey1 no-pop/blow-back featureaInner diameter shall not be wider than inner lumen.Figure 1 — Dimensions and configuration of Types A and B closuresCopyright International Organization for StandardizationProvided by IHS under license with ISONot for ResaleNo reproduction or networking permitted without license from IHS--`,,```,,,,````-`-`,,`,,`,`,,`---ISO 8362-2:2008(E)© ISO 2008 – All rights reserved3Table 1 — Dimensions of injection closuresDimensions in millimetresInjection vialsType Nominalsize d 1 ± 0,15 d 2 max. d 3 ± 0,2d 4 ± 0,2 h 1 min. h 2 ± 0,25 h 3 min. h 4 min. ISO 8362-1 ISO 8362-4 13 7,50 5 12,5 — 6,2 2,00 2,0 1,5 2 R and 4 R — A 20 13,20 10 18,8 — 8,5 3,30 2,0 1,5 6 R to 30 R5 H to 100 H 13 7,40 5 12,5 7,6 6,2 2,00 2,0 1,5 — 2 I to 10 I B2013,001018,813,38,53,302,01,5—6 H to 100 H4.2 If not otherwise specified, general dimensional tolerances shall be in accordance with ISO 3302-1 and ISO 3302-2.4.3 If spacers are located on top of the flange, they shall not interfere with the marks for the piercing area (see Figure 1). The height of the spacers shall not exceed 0,3 mm.NOTE The spacers in Figure 1 for Type A and Type B closures are shown for illustrative purposes only and do not form part of the requirements of this part of ISO 8362.4.4 If the flange of the closure has a slightly conical shape, it shall be 0,3 mm maximum in relation to the diameter in order to facilitate production. The tolerances of the trimming edge of the flange shall comply with the tolerances specified in Table 1 for diameter d 3. 4.5All edges of the closure may be rounded.5 DesignationClosures can be designated according to their type (see 4.1 and Figure 1). The designation is expressed as the number of this part of ISO 8362 followed by the nominal size of the closure followed by the type letter.EXAMPLE A Type A closure for injection vials of nominal size 13 complying with the requirements laid down in this part of ISO 8362 is designated as follows:Injection closure ISO 8362-2 - 13 - A6 MaterialThe elastomeric material used shall meet the requirements specified in Clause 7.The elastomeric material shall withstand two sterilization cycles when autoclaving in saturated steam at (121 ± 2) °C for 30 min without exceeding the specified limits and without impairment of its performance characteristics under the conditions of normal use. In case other sterilization methods are used, e.g. irradiation, the suitability of the material shall be evaluated.Closures shall be made from the elastomeric formulation originally tested and approved by the end user. The closure manufacturer shall ensure the conformance of each delivery with the type sample and the compliance with previously agreed functional and compendial requirements.7 Performance requirements7.1 GeneralThe requirements specified in 7.2 to 7.4 represent minimum requirements which refer to the condition of the elastomeric closures on receipt by the user.Copyright International Organization for Standardization Provided by IHS under license with ISONot for ResaleNo reproduction or networking permitted without license from IHS--`,,```,,,,````-`-`,,`,,`,`,,`---ISO 8362-2:2008(E)4© ISO 2008 – All rights reserved7.2 Physical requirements7.2.1 HardnessThe hardness agreed between manufacturer and user shall not differ from the nominal value by more than ± 5 Shore A when tested in accordance with ISO 7619-1 on a special test specimen. Alternatively, the hardness can be tested on the closures in accordance with ISO 48. If tested in accordance with ISO 48, the microhardness shall not differ by more than ± 5 IRHD from the type sample. 7.2.2 PenetrabilityThe requirements of ISO 8871-5:2005, 4.1, shall apply. 7.2.3 FragmentationThe requirements of ISO 8871-5:2005, 4.2, shall apply. 7.2.4 Self-sealing and container closure seal integrity The requirements of ISO 8871-5:2005, 4.3, shall apply. 7.2.5 Container closure seal integrityThe requirements of ISO 8871-5:2005, 4.4, shall apply. If the test specimen complies with 7.2.4, the requirements of this subclause have also been met and separate testing according to this subclause is not needed.7.2.6 Resistance to ageingThe maximum time between the date of manufacture and pharmaceutical use should be agreed upon between the manufacturer of the closures and the user.The closures shall maintain their performance characteristics throughout the entire shelf-life of the medicinal product, which is tested as part of the stability test by the user.NOTE Ageing depends upon the storage and handling conditions. Guidelines for storage of vulcanized rubber are given in ISO 2230.7.3 Chemical requirementsThe requirements of ISO 8871-1 shall apply.7.4 Biological requirementsThe requirements of ISO 8871-4 shall apply.8 LabellingPacked closures that meet the requirements of this part of ISO 8362 may be labelled with the designation given in Clause 5.Copyright International Organization for Standardization Provided by IHS under license with ISONot for ResaleNo reproduction or networking permitted without license from IHS--`,,```,,,,````-`-`,,`,,`,`,,`---ISO 8362-2:2008(E)© ISO 2008 – All rights reserved5Bibliography[1] ISO 2230, Rubber products — Guidelines for storage[2] ISO 15378, Primary packaging materials for medicinal products — Particular requirements for theapplication of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)Copyright International Organization for Standardization Provided by IHS under license with ISONot for ResaleNo reproduction or networking permitted without license from IHS--`,,```,,,,````-`-`,,`,,`,`,,`---ISO 8362-2:2008(E)ICS 11.040.20Price based on 5 pages--`,,```,,,,````-`-`,,`,,`,`,,`---© ISO 2008 – All rights reservedCopyright International Organization for StandardizationProvided by IHS under license with ISONo reproduction or networking permitted without license from IHSNot for Resale。
国内外包材知识
国内外药品包装及包材相应试验这是我不久前看到的网上的一篇文章，个人认为这是一篇很不错的关于药品包装方面的文章，特意转过来给各位看看，要是能完全理解这里面提到的内容，搞药品包装也就不是什么难事了！药品包装是指直接接触药品的包装材料和容器，属于专用包装范畴，它具有包装的所有属性，并有其特殊性：1、能保护药品在贮藏、使用过程中不受环境的影响,保持药品原有属性2、药品包装材料自身在贮藏、使用过程中性质应有一定的稳定性3、药品包装材料在包裹药品时不能污染药品生产环境。
4、药品包装材料不得带有在使用过程中不能消除的对所包装药物有影响的物质。
5、药品包装材料与所包装的药品不能发生化学、生物意义上的反应。
为了确认药品包装材料可被用于包裹药品,有必要对这些材料进行质量监控一、药品包装分类（一）按药品包装材料、容器所使用的成份可分为：塑料、橡胶（或弹性体）、玻璃、金属及其它类（如布类、陶瓷类、纸类、干燥剂类）等五类。
（二）按药品包装材料、容器的形状也可分为：容器（如口服固体药用高密度聚乙烯瓶等）、硬片或袋（如PVC固体药用硬片、药品包装用复合膜、袋等）、塞（如药用氯化丁基橡胶塞）、盖（如口服液瓶撕拉铝盖）、辅助用途（如输液接口）等五类。
二、药品包装材料标准体系为确保药品的安全、有效使用，各国均对药品包装材料和容器进行质量控制，标准体系主要有1、药典体系：各发达国家药典附录均收载有药品包装材料的技术要求2、ISO体系:根据材料及形状制定标准(如铝盖、玻璃输液瓶)3、各国工业标准体系:如英国工业标准BS等，已逐渐向ISO标准转化4、国内标准体系:工业标准形式上与ISO标准相同,安全项目略少于先进国家药典。
为有效控制药品包装材料的质量，国家食品药品监督管理局已于2002年始，制定并颁布相应的药品包装材料容器的质量标准，加强对材料的物理、机械性能、化学性能、安全性能的控制。
国际标准、各国药典都是药品包装国际市场共同遵循的技术依据，其中，药典侧重于材料、容器的安全性评价，国际标准侧重于产品使用性能的评价。
塑料软包装的国家检测标准2
塑料软包装的国家检测标准ZBY 28004—86 塑料膜包装袋热合强度测定方法GB/T 14903—94 无机胶粘剂套接扭转剪切强度试验方法GB/T 12954—91 建筑胶粘剂通用试验方法GB 11177—89 无机胶粘剂套接压缩剪切强度试验方法GB 7754—87 压敏胶粘带剪切强度试验方法（胶面对背面）GB 7753—87 压敏胶粘带拉伸性能试验方法GB/T 14705—93 报纸印刷品质量要求及检验方法GB 7707—87 凹版装潢印刷品GB 7706—87 凸版装潢印刷品GB 7705—87 平版装潢印刷品HG/T 2727—95（代替GB 11178—89）聚乙酸乙烯酯乳液木材胶粘剂HG/T 2493—93 鞋用氯丁橡胶胶粘剂HG/T 2406—92 压敏胶标签纸GB/T 15332—94 热熔胶粘剂软化占的测定环球法CY/T 17—95 印后加工纸基印刷品上光质量要求及检验方法CY/T 7.9—91 印后加工质量要求及检验方法裁质量要求及检验方法CY/T 7.7—91 印后加工质量要求及检验方法覆膜质量要求及方法CY/T 7.7—91 印后加工质量要求及检验方法胶粘装订质量要求及检验方法CY/T 6—91 凹版印刷品质量要求及检验方法GY/T 5—91 平版印刷品质量要求及检验方法CY/T 4—91 凸版印刷品质量要求及检验方法CY 3—91 色评价照明和观察条件CY 2—91 书刊印刷产品质量评价和分级方法GB 1449—83（代替GB 1449—78）玻璃纤维增强塑料弯曲性能试验方法塑料软包装的国家检测标准2GB 3356—82 单向纤维增强塑料弯曲性能试验方法GB 9341—88 塑料弯曲性能试验方法GB 1041—79 塑料压缩试验方法GB 8947—88 复合塑料编织袋SG 233—81 聚苯乙烯泡沫烹包装材料GB 4456—84 包装用聚乙烯吹塑薄膜SG 224—81 高压聚乙烯重包装袋（膜）GB 7749—87 胶粘剂劈裂强度试验方法（金属对金属）GB 7124—86 胶粘剂拉伸剪切强度测定方法GB/T 7122—1996 ISO 4578：1990 高强度胶粘剂剥离强度的测定浮辊法GB/T 6329—1996 ISO 6922：1987 胶粘剂对接接头拉伸强度的测定GB 6328—86 胶粘剂剪切冲击强度试验方法GB 4852—84 压敏胶粘带初粘性测试方法（斜面滚球法）GB 4850—84 压敏胶粘带低速解卷强度测试方法GB 4851—84 压敏胶粘带持粘性测试方法GB/T 2793——1995 胶粘剂不挥发物含量的测定GB 2792—81 压敏胶粘带动180°剥离强度测定方法GB/T 2791—1995 胶粘剂T剥离强度试验方法挠性材料对挠性材料GB/T 2790—1995 胶粘剂180°剥离强度试验方法挠性材料对刚性材料GB 12255—90 药品包装用铝箔GB/T 13477—92 建筑密封材料试验方法GB/T 6548—1998 瓦愣纸板粘合强度的测定法GB/T 15177—94 软包装个密封性能试验方法BB/T 0016—1999 包装材料蜂窝纸板QB/T 1130—91 塑料直角撕裂性能试验方法GB 8808—88 软质复合塑料材料剥离试验方法GB 8807—88 塑料镜面光泽试验方法QB/T 1871—93 双向拉伸尼龙（BOPA）/低密度聚乙烯（LDPE）复合膜、袋QB 1868—93 聚酯（PET）软饮料瓶QB 1233—91 钢塑复合桶QB 1123—91 纸—塑不织布复合包装袋GB 10005—88 双向拉伸聚丙复合低密度聚乙烯（BOPP/LDPE）薄膜和包装袋GB 1004—88 聚酯（PET）—铝箔（AI）—聚丙烯（CPP）复合膜、袋QB 1232—91 软质聚氨酯泡沫塑料复合材料GB 10808—89 软质泡沫塑料撕裂性能试验方法GB 10007—88 ISO1922—1981 硬质泡沫塑料剪切强度试验方法GB 9641—88 硬质泡沫塑料拉伸性能试验方法GB 8813—88 ISO 844—1978 硬质泡沫塑料压缩试验方法GB 8812—88 ISO 1209—76 硬质泡沫塑料弯曲试验方法GB 6666—86 ISO 1856—1980 软质泡沫聚合材料压缩永久变形的测定GB 6344—1996 ISO 1798—1983 （代替GB 6344——86）软质泡沫聚合物材料拉伸强度和断裂伸长率的测定GB 10010—88 医用软聚氯乙烯管材GB 5663—85 药用聚氯乙烯（PVC）硬片GB/T 16958—1997 包装用双向拉伸聚酯薄膜GB/T 16578—1996 塑料薄膜和薄片耐撕裂性能试验方法裤形撕裂法GB/T 13519—92 聚乙烯热收缩薄膜GB 11999—89 塑料薄膜和薄片耐撕裂性试验方法埃莱门多夫法GB 10006—88 ISO 8295—1986 塑料薄膜和薄片摩擦系数测定方法GB 10440—89 圆柱形复合罐GB 2637—90 安瓿GB 453—89（代替GB 453—79）纸和纸板抗张强度的测定法（恒速加荷法）GB 328.6—89 沥青防水卷材试验方法拉力GB 12255—90 药品包装用铝箔GB 10805—89 食品包装用硬质聚氯乙烯薄膜GB/T 12122—89 产品包装质量保证体系GB/T 12121—89 包装容器质量保证体系GB/T 4857.16—90 运输包装件基本试验采用压力试验机的堆码试验方法GB 4857.15—89 运输包装个基本试验可控水平冲击试验方法GB 4857.14—89 运输包装件基本试验倾翻试验方法GB 12904—91 通用商品条码GB 191—90 （代替GB 191—85 GB 5892—86）包装储运图示标志GB 4122—83 包装通用术语GB/T 16717—1996 包装容器重型瓦楞纸箱GB/T 4857.5—92 包装运输包装件跌落试验方法GB/T 4857.4—92 ISO 2872—1985 包装运输包装件压力试验方法GB/T 4857.3—92 （代替GB 4857.3—84）包装运输包装件静载荷堆码试验方法塑料软包装的国家检测标准3GB 8941.3—88 纸和纸板镜面光泽度测定法75°角测定法GB 8941.1—88 纸和纸板镜面光泽度测定法20°角测定法GB/T 6548—1998 瓦楞纸板粘合强度的测定法GB/T 6546—1989 瓦楞纸板边压强度的测定法GB/T 6545—1998 瓦楞纸板耐破强度的测定方法GB/T 2679.17—1997 瓦楞纸板边压强度的测定（边缘补强法）GB/T 2679.8—1995 纸和纸板环压强度的测定HG/T 2729—95 硫化橡胶与薄片摩擦系数的测定滑动法HG/T 2715—1995 橡胶或塑料涂覆织物抗粘合性的测定HG/T 2581—94 橡胶或塑料涂覆织物耐撕裂性能的测定HG/T 2580—94 橡胶或塑料涂覆织物拉伸强度和扯断伸长率的测定GB/T 16586—1996 硫化橡胶与钢丝帘线粘合强度的测定GB/T 15254—94 硫化橡胶与金属粘接下来180°剥离试验GB/T 13936—92 硫化橡胶与金属粘接拉伸剪切强度测定方法GB/T 12833—91 橡胶和塑料撕裂强度及粘合强度多峰曲线的分析方法GB 11211—89 硫化橡胶与金属粘合强度的测定拉伸法GB 7761—87 橡胶与刚性粘合强度的测定圆锥形个法GB 7760—87 硫化橡胶与金属粘合的测定单板法GB 3513—83 橡胶与单根钢丝粘合强度的测定抽出法GB/T 2942—91 硫化橡胶与织物帘线粘合强度的测定H抽出法GB 2438—81 硬质橡胶压碎强度的测定方法GB 1701—82 硬质橡胶抗张强度和扯断伸长率的测定GB 1700—82（代替GB 1700—79）硬质橡胶抗剪切强度试验方法GB 532—89 硫化橡胶与织物粘合强度的测定GB/T 529—91 硫化橡胶撕裂强度的测定（裤形、直角形和新月形试样）GB/T 528—92 硫化橡胶和热塑性橡胶拉伸性能的测定GB/T 17554—1998 识别卡测试方法YY 0203—95 药用铝瓶ZBC08003—87 药品铝塑泡罩包装YY 0131—93 口服液瓶撕拉铝盖YY 0236—1996 药品包装用复合膜（通则）HG 4—559—79 抗菌素橡胶瓶塞YY 0057—51 固体药用聚烯烃塑料瓶GB 5198.1—XXXX ISO 8362—3.1989 抗生素玻璃瓶盖第1部分：铝盖GB 5198.2—XXXX ISO 8362—6：1992 ISO 8362—7：1995 抗生素玻璃瓶盖第2部分：铝塑组合盖YY 0321.2—2000 一次性使用麻醉用针YY/T 1119—1999 医用高分子制品术语YY 0169.2—94 丁基橡胶抗生素瓶塞HG 4—1179—79 聚氯乙烯薄膜胶粘剂GB 13022—91 塑料薄膜拉伸性能试验方法GB 8941.3—88 纸和纸板镜面光泽度测定法45°角测定法YY/T 0313—1998 医用高分子产品包装、标志、运输和贮存YY 0242—1996 医用输液、输血、注射器用聚丙烯专用料YY 0114—93 医用输液、输血、注射器用聚乙专用料YY 0115—93 一次性使用采血器GB 14232—93 一次性使用塑料血袋GB 15593—1995 输血（液）器具用软聚氯乙烯塑料GB 12256—90 注射针针管刚度试验方法GB/T 14257～14258—93 通用商品条码符号位置条码符号印刷质量的检验GB/T 柔性版装璜印刷品（讨论稿）GB/T 12904 商品条码YY 0321.2—2000 一次性使用麻醉穿刺包GB/T 15812—1995 医用高分子软管物理性能试验方法YY 0169.1—94 丁基橡胶输液瓶塞GB 5197.1~5197.2—1996 玻璃输液瓶盖JC 482~485—92 建筑密封膏GB/T 16259—1996 彩色建筑材料人工气候加速颜色老化试验方法GB 11942—89 彩色建筑材料色度测量方法GB/T 13891—92 建筑饰面材料镜向光泽度测定方法GB 12002—89 塑料门窗用密封条GB/T 9775—1999 eqv ISO 6308：1980 纸面石膏板GB 11982.1—89 聚氯乙烯卷材地板带基材的聚氯乙烯卷材地板GB 11982.2—1996 聚氯乙烯卷板地板第2部分：有基材有背涂层聚氯乙烯卷材地板GB 18242—2000 弹性体改性沥青防水卷材GB 8721—88 炭素材料抗拉强度测定方法GB/T 13480—92 矿物棉制品压缩性能试验方法GB/T 14209—93 纺织玻璃纤维无捻粗纱棒状复合材料压缩强度的测定GB/T 14208—93 纺织玻璃纤维无捻粗纱棒状复合材料弯曲强度的测定GB/T 14206—93 玻璃纤维增强聚酯波纹板GB/T 13096.1~13096.4—91 拉挤玻璃纤维增强塑料杆力学性能试验方法GB 1446—83 纤维增强塑料性能试验方法GB 4085—83 半硬质聚氯乙烯块状塑料地板GB 15558.1—1995 燃气用埋地聚乙烯管材GB 15558.2—1995 燃气用埋地聚乙烯管件GB/T 2567~2571—1995 树脂浇铸体性能试验方法GB/T 541—1996 石棉橡胶板试验方法GB/T 16679—1997 纤维增强塑料层合板拉- 拉疲劳性能试验方法GB 9774—1996 水泥包装袋GB/T 14074.1~14074.18—93 木材胶粘剂及其树脂检验方法GB 1452~1453—87 GB 1464—87 非金属夹层结构或芯子试验方法GB 1454~1457—88 夹层结构性能试验方法GB/T 11718—1999 中密度纤维板GB/T 17657—1999 人造板及饰面人造板理化性能试验方法GB/T 15102—94 浸渍胶膜纸饰面人造板GB 1038－70 塑料薄膜透气性试验方法GB 1037－70 塑料透湿性试验方法GB 9639-88 塑料薄膜和薄片抗冲击性能试验方法自由落镖法GB 11999-89 塑料薄膜和薄片耐撕裂性能试验方法埃莱门多夫法GB／T1038-2000（代替GB/T1038-1970）塑料薄膜和薄片气体透过性试验方法压差法纸箱包装标准超强下载(不要再浪费时间了,基本上都有)瓦楞纸板、瓦楞纸箱及其材料的国家标准、行业标准及有关标准/discuz/viewthread.php?tid=&fromuid=GJB 1109A-1999 军用瓦楞纸箱/discuz/viewthread.php?tid=&fromuid=GB/T 16717-1996 包装容器重型瓦楞纸箱/discuz/viewthread.php?tid=&fromuid=YC/T 137.1-2004 复烤片烟包装瓦楞纸箱包装/discuz/viewthread.php?tid=&fromuid=GB 12986-91 纸箱制图/discuz/viewthread.php?tid=&fromuid=GB/T 16717-1996 包装容器重型瓦楞纸箱/discuz/viewthread.php?tid=&fromuid=GB 5033-1985 出口产品包装用瓦楞纸箱/discuz/viewthread.php?tid=&fromuid=SN/T 0912-2000 进出口茶叶包装检验方法/discuz/viewthread.php?tid=&fromuid=SN 0449.1-1995 海运出口危险货物包装检验规程总则(全套标准)/discuz/viewthread.php?tid=&fromuid=SN/T 0004-1995 进出口商品运输包装检验规程标准编写的基本规定/discuz/viewthread.php?tid=&fromuid=以上是我匆忙帮大家找来了,纸箱包装的标准十之七八可以那里找到!!收集来可以卖标准了,呵~。
塑料软包装的国家检测标准
塑料软包装的国家检测标准ZBY 28004—86 塑料膜包装袋热合强度测定方法GB/T 14903—94 无机胶粘剂套接改变剪切强度试验方法GB/T 12954—91 建筑胶粘剂通用试验方法GB 11177—89 无机胶粘剂套接压缩剪切强度试验方法GB 7754—87 压敏胶粘带剪切强度试验方法〔胶面对反面〕GB 7753—87 压敏胶粘带拉伸性能试验方法GB/T 14705—93 报纸印刷品质量要求及检验方法GB 7707—87 凹版装潢印刷品GB 7706—87 凸版装潢印刷品GB 7705—87 平版装潢印刷品HG/T 2727—95〔代替GB 11178—89〕聚乙酸乙烯酯乳液木材胶粘剂HG/T 2493—93 鞋用氯丁橡胶胶粘剂HG/T 2406—92 压敏胶标签纸GB/T 15332—94 热熔胶粘剂软化占的测定环球法CY/T 17—95 印后加工纸基印刷品上光质量要求及检验方法CY/T 7.9—91 印后加工质量要求及检验方法裁质量要求及检验方法CY/T 7.7—91 印后加工质量要求及检验方法覆膜质量要求及方法CY/T 7.7—91 印后加工质量要求及检验方法胶粘装订质量要求及检验方法CY/T 6—91 凹版印刷品质量要求及检验方法GY/T 5—91 平版印刷品质量要求及检验方法CY/T 4—91 凸版印刷品质量要求及检验方法CY 3—91 色评价照明和观察条件CY 2—91 书刊印刷产品质量评价和分级方法GB 1449—83〔代替GB 1449—78〕玻璃纤维增强塑料弯曲性能试验方法塑料软包装的国家检测标准2GB 3356—82 单向纤维增强塑料弯曲性能试验方法GB 9341—88 塑料弯曲性能试验方法GB 1041—79 塑料压缩试验方法GB 8947—88 复合塑料编织袋SG 233—81 聚苯乙烯泡沫烹包装材料GB 4456—84 包装用聚乙烯吹塑薄膜SG 224—81 高压聚乙烯重包装袋〔膜〕GB 7749—87 胶粘剂劈裂强度试验方法〔金属对金属〕GB 7124—86 胶粘剂拉伸剪切强度测定方法GB/T 7122—1996 ISO 4578：1990 高强度胶粘剂剥离强度的测定浮辊法GB/T 6329—1996 ISO 6922：1987 胶粘剂对接接头拉伸强度的测定GB 6328—86 胶粘剂剪切冲击强度试验方法GB 4852—84 压敏胶粘带初粘性测试方法〔斜面滚球法〕GB 4850—84 压敏胶粘带低速解卷强度测试方法GB 4851—84 压敏胶粘带持粘性测试方法GB/T 2793——1995 胶粘剂不挥发物含量的测定GB 2792—81 压敏胶粘带动180°剥离强度测定方法GB/T 2791—1995 胶粘剂T剥离强度试验方法挠性材料对挠性材料GB/T 2790—1995 胶粘剂180°剥离强度试验方法挠性材料对刚性材料GB 12255—90 药品包装用铝箔GB/T 13477—92 建筑密封材料试验方法GB/T 6548—1998 瓦愣纸板粘合强度的测定法GB/T 15177—94 软包装个密封性能试验方法BB/T 0016—1999 包装材料蜂窝纸板QB/T 1130—91 塑料直角撕裂性能试验方法GB 8808—88 软质复合塑料材料剥离试验方法GB 8807—88 塑料镜面光泽试验方法QB/T 1871—93 双向拉伸尼龙〔BOPA〕/低密度聚乙烯〔LDPE〕复合膜、袋QB 1868—93 聚酯〔PET〕软饮料瓶QB 1233—91 钢塑复合桶QB 1123—91 纸—塑不织布复合包装袋GB 10005—88 双向拉伸聚丙复合低密度聚乙烯〔BOPP/LDPE〕薄膜和包装袋GB 1004—88 聚酯〔PET〕—铝箔〔AI〕—聚丙烯〔CPP〕复合膜、袋QB 1232—91 软质聚氨酯泡沫塑料复合材料GB 10808—89 软质泡沫塑料撕裂性能试验方法GB 10007—88 ISO1922—1981 硬质泡沫塑料剪切强度试验方法GB 9641—88 硬质泡沫塑料拉伸性能试验方法GB 8813—88 ISO 844—1978 硬质泡沫塑料压缩试验方法GB 8812—88 ISO 1209—76 硬质泡沫塑料弯曲试验方法GB 6666—86 ISO 1856—1980 软质泡沫聚合材料压缩永久变形的测定GB 6344—1996 ISO 1798—1983 〔代替GB 6344——86〕软质泡沫聚合物材料拉伸强度和断裂伸长率的测定GB 10010—88 医用软聚氯乙烯管材GB 5663—85 药用聚氯乙烯〔PVC〕硬片GB/T 16958—1997 包装用双向拉伸聚酯薄膜GB/T 16578—1996 塑料薄膜和薄片耐撕裂性能试验方法裤形撕裂法GB/T 13519—92 聚乙烯热收缩薄膜GB 11999—89 塑料薄膜和薄片耐撕裂性试验方法埃莱门多夫法GB 10006—88 ISO 8295—1986 塑料薄膜和薄片摩擦系数测定方法GB 10440—89 圆柱形复合罐GB 2637—90 安瓿GB 453—89〔代替GB 453—79〕纸和纸板抗张强度的测定法〔恒速加荷法〕GB 328.6—89 沥青防水卷材试验方法拉力GB 12255—90 药品包装用铝箔GB 10805—89 食品包装用硬质聚氯乙烯薄膜GB/T 12122—89 产品包装质量保证体系GB/T 12121—89 包装容器质量保证体系GB/T 4857.16—90 运输包装件根本试验采用压力试验机的堆码试验方法GB 4857.15—89 运输包装个根本试验可控程度冲击试验方法GB 4857.14—89 运输包装件根本试验倾翻试验方法GB 12904—91 通用商品条码GB 191—90 〔代替GB 191—85 GB 5892—86〕包装储运图示标志GB 4122—83 包装通用术语GB/T 16717—1996 包装容器重型瓦楞纸箱GB/T 4857.5—92 包装运输包装件跌落试验方法GB/T 4857.4—92 ISO 2872—1985 包装运输包装件压力试验方法GB/T 4857.3—92 〔代替GB 4857.3—84〕包装运输包装件静载荷堆码试验方法塑料软包装的国家检测标准3GB 8941.3—88 纸和纸板镜面光泽度测定法75°角测定法GB 8941.1—88 纸和纸板镜面光泽度测定法20°角测定法GB/T 6548—1998 瓦楞纸板粘合强度的测定法GB/T 6546—1989 瓦楞纸板边压强度的测定法GB/T 6545—1998 瓦楞纸板耐破强度的测定方法GB/T 2679.17—1997 瓦楞纸板边压强度的测定〔边缘补强法〕GB/T 2679.8—1995 纸和纸板环压强度的测定HG/T 2729—95 硫化橡胶与薄片摩擦系数的测定滑动法HG/T 2715—1995 橡胶或塑料涂覆织物抗粘合性的测定HG/T 2581—94 橡胶或塑料涂覆织物耐撕裂性能的测定HG/T 2580—94 橡胶或塑料涂覆织物拉伸强度和扯断伸长率的测定GB/T 16586—1996 硫化橡胶与钢丝帘线粘合强度的测定GB/T 15254—94 硫化橡胶与金属粘接下来180°剥离试验GB/T 13936—92 硫化橡胶与金属粘接拉伸剪切强度测定方法GB/T 12833—91 橡胶和塑料撕裂强度及粘合强度多峰曲线的分析方法GB 11211—89 硫化橡胶与金属粘合强度的测定拉伸法GB 7761—87 橡胶与刚性粘合强度的测定圆锥形个法GB 7760—87 硫化橡胶与金属粘合的测定单板法GB 3513—83 橡胶与单根钢丝粘合强度的测定抽出法GB/T 2942—91 硫化橡胶与织物帘线粘合强度的测定H抽出法GB 2438—81 硬质橡胶压碎强度的测定方法GB 1701—82 硬质橡胶抗张强度和扯断伸长率的测定GB 1700—82〔代替GB 1700—79〕硬质橡胶抗剪切强度试验方法GB 532—89 硫化橡胶与织物粘合强度的测定GB/T 529—91 硫化橡胶撕裂强度的测定〔裤形、直角形和新月形试样〕GB/T 528—92 硫化橡胶和热塑性橡胶拉伸性能的测定GB/T 17554—1998 识别卡测试方法YY 0203—95 药用铝瓶ZBC08003—87 药品铝塑泡罩包装YY 0131—93 口服液瓶撕拉铝盖YY 0236—1996 药品包装用复合膜〔通那么〕HG 4—559—79 抗菌素橡胶瓶塞YY 0057—51 固体药用聚烯烃塑料瓶GB 5198.1—XXXX ISO 8362—3.1989 抗生素玻璃瓶盖第1局部：铝盖GB 5198.2—XXXX ISO 8362—6：1992 ISO 8362—7：1995 抗生素玻璃瓶盖第2局部：铝塑组合盖YY 0321.2—2000 一次性使用麻醉用针YY/T 1119—1999 医用高分子制品术语YY 0169.2—94 丁基橡胶抗生素瓶塞HG 4—1179—79 聚氯乙烯薄膜胶粘剂GB 13022—91 塑料薄膜拉伸性能试验方法GB 8941.3—88 纸和纸板镜面光泽度测定法45°角测定法YY/T 0313—1998 医用高分子产品包装、标志、运输和贮存YY 0242—1996 医用输液、输血、注射器用聚丙烯专用料YY 0114—93 医用输液、输血、注射器用聚乙专用料YY 0115—93 一次性使用采血器GB 14232—93 一次性使用塑料血袋GB 15593—1995 输血〔液〕器具用软聚氯乙烯塑料GB 12256—90 注射针针管刚度试验方法GB/T 14257～14258—93 通用商品条码符号位置条码符号印刷质量的检验GB/T 柔性版装璜印刷品〔讨论稿〕GB/T 12904 商品条码YY 0321.2—2000 一次性使用麻醉穿刺包GB/T 15812—1995 医用高分子软管物理性能试验方法YY 0169.1—94 丁基橡胶输液瓶塞GB 5197.1~5197.2—1996 玻璃输液瓶盖JC 482~485—92 建筑密封膏GB/T 16259—1996 彩色建筑材料人工气候加速颜色老化试验方法GB 11942—89 彩色建筑材料色度测量方法GB/T 13891—92 建筑饰面材料镜向光泽度测定方法GB 12002—89 塑料门窗用密封条GB/T 9775—1999 eqv ISO 6308：1980 纸面石膏板GB 11982.1—89 聚氯乙烯卷材地板带基材的聚氯乙烯卷材地板GB 11982.2—1996 聚氯乙烯卷板地板第2局部：有基材有背涂层聚氯乙烯卷材地板GB 18242—2000 弹性体改性沥青防水卷材GB 8721—88 炭素材料抗拉强度测定方法GB/T 13480—92 矿物棉制品压缩性能试验方法GB/T 14209—93 纺织玻璃纤维无捻粗纱棒状复合材料压缩强度的测定GB/T 14208—93 纺织玻璃纤维无捻粗纱棒状复合材料弯曲强度的测定GB/T 14206—93 玻璃纤维增强聚酯波纹板GB/T 13096.1~13096.4—91 拉挤玻璃纤维增强塑料杆力学性能试验方法GB 1446—83 纤维增强塑料性能试验方法GB 4085—83 半硬质聚氯乙烯块状塑料地板GB 15558.1—1995 燃气用埋地聚乙烯管材GB 15558.2—1995 燃气用埋地聚乙烯管件GB/T 2567~2571—1995 树脂浇铸体性能试验方法GB/T 541—1996 石棉橡胶板试验方法GB/T 16679—1997 纤维增强塑料层合板拉- 拉疲劳性能试验方法GB 9774—1996 水泥包装袋GB/T 14074.1~14074.18—93 木材胶粘剂及其树脂检验方法GB 1452~1453—87 GB 1464—87 非金属夹层构造或芯子试验方法GB 1454~1457—88 夹层构造性能试验方法GB/T 11718—1999 中密度纤维板GB/T 17657—1999 人造板及饰面人造板理化性能试验方法GB/T 15102—94 浸渍胶膜纸饰面人造板GB 1038－70 塑料薄膜透气性试验方法GB 1037－70 塑料透湿性试验方法GB 9639-88 塑料薄膜和薄片抗冲击性能试验方法自由落镖法GB 11999-89 塑料薄膜和薄片耐撕裂性能试验方法埃莱门多夫法GB／T1038-2000〔代替GB/T1038-1970〕塑料薄膜和薄片气体透过性试验方法压差法纸箱包装标准超强下载(不要再浪费时间了,根本上都有)瓦楞纸板、瓦楞纸箱及其材料的国家标准、行业标准及有关标准GJB 1109A-1999 军用瓦楞纸箱GB/T 16717-1996 包装容器重型瓦楞纸箱YC/T 137.1-2004 复烤片烟包装瓦楞纸箱包装GB 12986-91 纸箱制图GB/T 16717-1996 包装容器重型瓦楞纸箱GB 5033-1985 出口产品包装用瓦楞纸箱SN/T 0912-2000 进出口茶叶包装检验方法SN 0449.1-1995 海运出口危险货物包装检验规程总那么(全套标准)SN/T 0004-1995 进出口商品运输包装检验规程标准编写的根本规定以上是我匆忙帮大家找来了,纸箱包装的标准十之七八可以那里找到!!搜集来可以卖标准了,呵~。
医疗器械检测对应的标准
TSQB08-00 抗生素瓶用铝塑组合盖质量标准及检验操作规程
1 目 的：建立抗生素瓶用铝塑组合盖的质量标准并规范抗生素瓶用铝塑组合盖检验操作。
2 范 围：本规程适用于抗生素瓶用铝塑组合盖的质量检验及质量判定。
3 标准依据：《国家食品药品监督管理局国家药品包装容器（材料）标准 (试行)》 YBB00372003 4 内 容： 4.1 类别：药用包材。
4.2 物料代码：B084.3 贮藏：密闭，干燥处保存。
4.4 质量要求： 4.4.1 质量标准：项目 标准外观 应清洁，无残留润滑剂、毛刺、损伤和注塑飞边，塑料件应与铝件完全结合 凸边 应不大于3%耐灭菌 瓶盖应不出现断裂和异常变形 规格尺寸应符合表1的规定注：其他项目由生产厂家进行检验，检验结果见厂家报告单。
4.4.2 规格尺寸表1 规格尺寸公称 型式铝盖内塑片外径铝盖厚度 铝盖内高 瓶盖全高题 目 抗生素瓶用铝塑组合盖 质量标准及检验操作规程文件编码 TSQB08-00 制 定 人 制定日期 年 月 日 文件页数 共 6页 审 核 人 审核日期 年 月 日 生效日期 年 月 日 批 准 人批准日期 年 月 日 颁发部门质量部分发部门 质量部（QC 、QA ）、物控部、采购供应部4.4.3 检验方法 4.4.3.1 外观方法：取本品适量，在自然光线明亮处，正视目测。
4.4.3.2 凸边A)仪器与用具：游标卡尺。
B)方法：取瓶盖适量，用游标卡尺测量，精确至0.1cm 。
瓶盖铝件的凸边应不大于3%。
铝件边缘的凸边以百分率表示，按下式计算：%100%minminmax⨯-=H H H 凸边式中：max H ---为铝件外侧最大高度minH ---为铝件外测最小高度4.4.3.3 耐灭菌A)仪器与用具：YXQ-LS-50S Ⅱ立式压力蒸汽灭菌器。
B)方法：取瓶盖适量，封盖后置蒸汽灭菌器中，121℃±2℃ 30min （包含130℃±2℃ 5min ），瓶盖经灭菌后塑料件能经受121℃（130℃）的蒸汽灭菌温度，无变形变色，铝件表面不应有任何明显变化。
药用玻璃输液瓶规格尺寸及其外观
中国医药包装协会标准YBX-2002-2008药用玻璃输液瓶规格尺寸与外观Glass Infusion Bottles specifications and standard size2008-xx-xx发布2008-xx-xx实施中国医药包装协会发布前言本标准参照ISO8536-1：2000《医用输液器具》第1部分《玻璃输液瓶》GB2639-90《玻璃输液瓶》和YBB00032002《钠钙玻璃输液瓶》本标准作为贸易供货签约使用本标准将YBB标准与GB2639-90标准进行整合，主要规定了规格尺寸和外观质量，材质要求按YBB 标准本标准由中国医药包装协会提出本标准起草单位：南通耀荣玻璃股份有限公司本标准主要起草人：董孝兴、吉志华本标准首次发布药用玻璃输液瓶的规格尺寸与外观1 范围本标准规定了玻璃输液瓶的产品分类、规格尺寸、外观质量、抽样试验方法及标志、包装、运输、贮存。
其它要求应符合YBB标准。
本标准适用于一次性使用的注射用玻璃输液瓶。
2 规范性引用文件下列文件中的条款通过本标准的引用而成为本标准的条款。
此标准引用文件，其随后所有的修改单(不包括勘误的内容)或修订版不适用于本标准。
鼓励根据本部分达成协议的各方研究是否可使用这些文件的最新版本。
GB2639-90 玻璃输液瓶YBB00032005 钠钙玻璃输液瓶ISO8536-1：2000 医用输液器具第1部分：玻璃输液瓶YBB00192003 垂直轴偏差测定法GB191 包装储运图示标志GB6543 瓦楞纸GB/T2828.1 逐批检查计数抽样程序及抽样表(适用于连续批的检查)3 产品分类3.1 产品按玻璃类型分为Ⅰ型和Ⅱ型，并应标记在瓶子底部。
3.2 产品按瓶型分为A型与C型。
4 规格尺寸4.1 A型瓶的规格尺寸应符合图1和表1的规定4.2 C型瓶的规格尺寸应符合图2和表2的规定5 外观质量5.1 输液瓶内、外不应有玻璃搭丝、飞翅尖刺。
5.2 裂纹：任何部位不应有(表面点碰状痕不作裂纹论)。
一次性使用输注器具产品注册技术审查指导原则
附件8：(食药监局2011年03月24日发布)一次性使用输注器具产品注册技术审查指导原则一、前言本指导原则旨在帮助和指导申请者/生产企业对一次性输注器具产品注册申报资料进行准备，以满足技术审评的基本要求。
同时有助于审评机构对该类产品进行科学规范的审评，提高审评工作的质量和效率。
本指导原则是对一次性使用输注器具产品注册申报资料的一般要求，申请者/生产企业应依据具体产品的特性对注册申报资料的内容进行充实和细化，并依据具体产品的特性确定其中的具体内容是否适用。
本指导原则是对生产企业和审查人员的指导性文件, 但不包括注册审批所涉及的行政事项，亦不作为法规强制执行, 如果有能够满足相关法规要求的其他方法，也可以采用，但是需要提供详细的研究资料和验证资料。
应在遵循相关法规的前提下使用本指导原则。
本指导原则是在现行法规和标准体系以及当前认知水平下制定的，随着法规和标准的不断完善，以及科学技术的不断发展，本指导原则相关内容也将进行适时的调整。
二、适用范围临床治疗与诊断时一次性使用，用于将容器内的液体通过插入静脉的针头或导管输入患者血管的器械及用于将液体注入人体和抽取人体体液的器具及其组件统称为一次性使用输注器具。
一次性使用输注器具包括：一次性使用输液器、一次性使用输血器、一次性使用滴定管式输液器、一次性使用静脉输液针、一次性使用精密过滤输液器、一次性使用袋式输液器、一次性使用输液连接管路、一次性使用输注泵、一次性使用无菌注射器、一次性使用无菌注射针、一次性使用无菌胰岛素注射器、一次性使用固定剂量疫苗注射器、一次性使用高压造影注射器、一次性使用自毁式注射器等产品，也包括基本结构和预期用途与上述产品相似的产品及其组件，如一次性使用无菌注射器用活塞、一次性使用肝素帽、无针输注装置、三通阀、药液过滤器等器具。
三、基本要求产品的技术资料应当从技术层面论述申报产品的用途、设计、技术特征、与已上市产品的比较、原材料控制、生产工艺、产品包装验证、产品灭菌验证、产品有效期验证、产品性能要求及依据。
一次性使用输注器具产品注册技术审查指导原则
附件8：(食药监局2011年03月24日发布)一次性使用输注器具产品注册技术审查指导原则一、前言本指导原则旨在帮助和指导申请者/生产企业对一次性输注器具产品注册申报资料进行准备，以满足技术审评的基本要求。
同时有助于审评机构对该类产品进行科学规范的审评，提高审评工作的质量和效率。
本指导原则是对一次性使用输注器具产品注册申报资料的一般要求，申请者/生产企业应依据具体产品的特性对注册申报资料的内容进行充实和细化，并依据具体产品的特性确定其中的具体内容是否适用。
本指导原则是对生产企业和审查人员的指导性文件, 但不包括注册审批所涉及的行政事项，亦不作为法规强制执行, 如果有能够满足相关法规要求的其他方法，也可以采用，但是需要提供详细的研究资料和验证资料。
应在遵循相关法规的前提下使用本指导原则。
本指导原则是在现行法规和标准体系以及当前认知水平下制定的，随着法规和标准的不断完善，以及科学技术的不断发展，本指导原则相关内容也将进行适时的调整。
二、适用范围临床治疗与诊断时一次性使用，用于将容器内的液体通过插入静脉的针头或导管输入患者血管的器械及用于将液体注入人体和抽取人体体液的器具及其组件统称为一次性使用输注器具。
一次性使用输注器具包括：一次性使用输液器、一次性使用输血器、一次性使用滴定管式输液器、一次性使用静脉输液针、一次性使用精密过滤输液器、一次性使用袋式输液器、一次性使用输液连接管路、一次性使用输注泵、一次性使用无菌注射器、一次性使用无菌注射针、一次性使用无菌胰岛素注射器、一次性使用固定剂量疫苗注射器、一次性使用高压造影注射器、一次性使用自毁式注射器等产品，也包括基本结构和预期用途与上述产品相似的产品及其组件，如一次性使用无菌注射器用活塞、一次性使用肝素帽、无针输注装置、三通阀、药液过滤器等器具。
三、基本要求产品的技术资料应当从技术层面论述申报产品的用途、设计、技术特征、与已上市产品的比较、原材料控制、生产工艺、产品包装验证、产品灭菌验证、产品有效期验证、产品性能要求及依据。
临床使用铝塑盖式注射剂免消毒的研究
临床使用铝塑盖式注射剂免消毒的研究目的验证临床使用铝塑盖式注射剂免消毒的客观依据。
方法生物监测与药物临床不良反应监测：①生物监测：a试验组将50份铝塑盖式注射剂瓶开启塑料盖后不进行消毒按无菌原则直接抽取瓶内液体、对照组将50份铝塑盖式注射剂瓶开启塑料盖后用碘伏消毒液消毒，待干按无菌原则抽取瓶内液体，分别进行48 h细菌培养；b试验组将铝塑盖式注射剂瓶开启塑料盖后不消毒与对照组消毒后待干两种方法各50份，分别用无菌棉签蘸无菌生理盐水涂抹瓶口塑料部分数次，放入无菌试管中，回实验室接种平板，将培养皿至37°恒温培养48 h，计算菌落数；②临床药物不良反应监测：对比2014年使用铝塑盖式注射剂瓶启封后进行消毒与2015年使用铝塑盖式注射剂瓶启封后不进行消毒的药物不良反应病例报告。
结果实验a和实验b中的试验组与对照组均无细菌生长，2014年与2015年2年的注射剂用药不良反应报告病例数无统计学意义。
标签：临床使用；铝塑盖式注射剂；免消毒；研究有文獻报道塑料瓶盖液体不需要常规消毒[1]，而在输液操作过程中，按操作规程，开启输液瓶盖后要常规用碘伏消毒液消毒瓶塞[2]，待消毒液干后再进行药液配制，2012年护理部查房时发现护士配铝塑盖式注射剂的药时也不消毒瓶口，直接加药和输液。
护理部将此情况向院感科汇报，院感科立即进行相关资料查询，医院院感科做出规定除塑料瓶盖液体不需要常规消毒外，其它工艺的注射用药一律常规消毒后使用。
2014年院感科开始用生物监测法来验证铝塑盖式注射剂免消毒的客观依据，得到有力的证据之后，院感科在2015年开始允许护士使用铝塑盖式注射药可以不消毒瓶口。
并将2014年和2015年的临床注射用药不良反应病例监测进行比较，结果不消毒与消毒的临床不良反应的病例数无统计学意义。
现将研究结果报道如下。
1 资料与方法1.1材料铝塑盖式盐酸氨溴索葡萄糖注射液100 ml（生产厂家：安徽双鹤药业有限责任公司，批号：131223，数量100瓶）2 ml一次性无菌注射器（生产厂家：江西庐乐医疗器械集团有限公司，批号：20130626，数量：100支）碘消毒液（生产厂家：江西草珊瑚消毒用品有限公司批号：20140102），一次性使用培养皿（泰兴市古溪玻璃仪器厂生产）；营养琼脂培养基（宜兴市永信生物有限公司生产）高压灭菌后备用；隔水式电热恒温培养箱（上海跃进医用光学器械厂）。
ISO 8362-6-2010 注射容器及附件.注射小瓶用铝塑组合盖
Reference number ISO 8362-6:2010(E)© ISO 2010INTERNATIONAL STANDARD ISO 8362-6Second edition 2010-06-01Injection containers and accessories — Part 6:Caps made of aluminium-plastics combinations for injection vialsRécipients et accessoires pour produits injectables —Partie 6: Capsules pour flacons d'injection fabriquées en un mélange aluminium-plastiqueCopyright International Organization for Standardization --`,,```,,,,````-`-`,,`,,`,`,,`---ISO 8362-6:2010(E)PDF disclaimerThis PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed butshall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area.Adobe is a trademark of Adobe Systems Incorporated.Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.COPYRIGHT PROTECTED DOCUMENT© ISO 2010All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright officeCase postale 56 • CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyright@ Web Published in Switzerlandii© ISO 2010 – All rights reservedCopyright International Organization for Standardization --`,,```,,,,````-`-`,,`,,`,`,,`---ISO 8362-6:2010(E)© ISO 2010 – All rights reservediii ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 8362-6 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use .This second edition cancels and replaces the first edition (ISO 8362-6:1992), Clause 2, 6.2 and Table 2 of which have been technically revised.ISO 8362 consists of the following parts, under the general title Injection containers and accessories : ⎯ Part 1: Injection vials made of glass tubing ⎯ Part 2: Closures for injection vials ⎯ Part 3: Aluminium caps for injection vials ⎯ Part 4: Injection vials made of moulded glass ⎯ Part 5: Freeze drying closures for injection vials⎯ Part 6: Caps made of aluminium-plastics combinations for injection vials⎯ Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics partCopyright International Organization for Standardization --`,,```,,,,````-`-`,,`,,`,`,,`---ISO 8362-6:2010(E)iv© ISO 2010 – All rights reservedIntroductionThe materials from which injection containers (including elastomeric closures) are made are suitable primary packaging materials for storing injectable products until they are administered. However, in this part of ISO 8362, caps are not considered as primary packaging materials in direct contact with pharmaceutical preparations.Copyright International Organization for Standardization --`,,```,,,,````-`-`,,`,,`,`,,`---INTERNATIONAL STANDARD ISO 8362-6:2010(E)© ISO 2010 – All rights reserved1Injection containers and accessories —Part 6:Caps made of aluminium-plastics combinations for injection vials1 ScopeThis part of ISO 8362 specifies caps made of aluminium-plastics combinations for injection vials as specified in ISO 8362-1 and ISO 8362-4.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 2768-1, General tolerances — Part 1: Tolerances for linear and angular dimensions without individual tolerance indicationsISO 2768-2, General tolerances — Part 2: Geometrical tolerances for features without individual tolerance indicationsISO 8362-3, Injection containers and accessories — Part 3: Aluminium caps for injection vialsISO 8872:2003, Aluminium caps for transfusion, infusion and injection bottles — General requirements and test methodsISO 10985, Caps made of aluminium-plastics combinations for infusion bottles and injection vials — Requirements and test methods3 Classification of typesCaps shall be classified as follows:⎯ Type ZB: aluminium cap with central opening and plastics component; ⎯ Type ZD: aluminium cap with complete tear-off tab and plastics component.Copyright International Organization for Standardization --`,,```,,,,````-`-`,,`,,`,`,,`---ISO 8362-6:2010(E)2© ISO 2010 – All rights reserved4 Dimensions and tolerances4.1 DimensionsAll cover versions (flat, ring-shaped or others) of caps shall meet the dimensions given in Figure 1 and Table 1.NOTEThe configuration of the cap shown in Figure 1 is informative only.4.2 TolerancesThe tolerances shall be in accordance with ISO 2768-1 and ISO 2768-2.Dimensions in millimetresType ZBType ZDKey1 plastics component 2aluminium cap in accordance with ISO 8362-3 3 score lineFigure 1 — Configuration of cap Table 1 — Dimensions of capDimensions in millimetresd 1d 2a d 3be ch 1 h 2dNominalsize0,10+min.max.min.max.min.max.±0,2min.max.13 13,3 15 16 3 8 6,3 7,3 8,420 20,3 22,2 23,2 6 10 0,168 0,2427,3 8,7 9,8a The diameter d 2shall be agreed upon between the manufacturer and user. It shall not differ from the nominal value by more than±0,25 mm. The extreme limits are given without tolerance.bAfter plastics element removal.c The thickness e shall be agreed upon between the manufacturer and user. It shall not differ from the nominal value by more than ±0,022 mm. The extreme limits are given without tolerance.d The height h 2shall be agreed upon between the manufacturer and user. It shall not differ from the nominal value by more than±0,3 mm. The extreme limits are given without tolerance.Copyright International Organization for Standardization--`,,```,,,,````-`-`,,`,,`,`,,`---ISO 8362-6:2010(E)© ISO 2010 – All rights reserved35 DesignationAluminium-plastics caps shall be designated according to type; the designation shall be expressed as the word “cap”, the number and part of this part of ISO 8362 followed by the type letters, followed by the nominal size of the container.For example, a Type ZD aluminium-plastics cap of nominal size 13 complying with the requirements laid down in this part of ISO 8362 is designated as follows:Cap ISO 8362-6 - ZD - 136 Requirements6.1 General requirements6.1.1The requirements for aluminium caps shall be in accordance with ISO 8362-3.6.1.2 The requirements for plastics components, and the combination between the plastics component and the aluminium cap, shall be in accordance with ISO 10985.6.1.3 Construction elements which penetrate into the interior space of the aluminium cap shall not interfere with the sealing process.6.2 Forces required to remove tab6.2.1The maximum forces required to remove the tab shall comply with Table 2.6.2.2 For incoming control, a minimum value for the tear-off tab removal force shall be agreed between the supplier and user. The injection caps shall also withstand a sterilization process in accordance with ISO 8872:2003, 5.1.Table 2 — Forces required to completely remove plastics component and tear-off tabForces in newtonsNominal sizeForce to remove plastics component(in accordance with ISO 10985)max.Force to remove tear-off tab completely(in accordance with ISO 8872)max. 13 2025 3530 407 PackagingPackaging shall comply with the requirements of ISO 8872.8 MarkingMarking shall be in accordance with ISO 8872 and the designation shall be as specified in Clause 5.Copyright International Organization for Standardization --`,,```,,,,````-`-`,,`,,`,`,,`---ISO 8362-6:2010(E)ICS 11.040.20Price based on 3 pages--`,,```,,,,````-`-`,,`,,`,`,,`---© ISO 2010 – All rights reservedCopyright International Organization for Standardization。
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Reference number ISO 8362-6:2010(E)© ISO 2010INTERNATIONAL STANDARD ISO 8362-6Second edition 2010-06-01Injection containers and accessories — Part 6:Caps made of aluminium-plastics combinations for injection vialsRécipients et accessoires pour produits injectables —Partie 6: Capsules pour flacons d'injection fabriquées en un mélange aluminium-plastiqueCopyright International Organization for Standardization --`,,```,,,,````-`-`,,`,,`,`,,`---ISO 8362-6:2010(E)PDF disclaimerThis PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed butshall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area.Adobe is a trademark of Adobe Systems Incorporated.Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.COPYRIGHT PROTECTED DOCUMENT© ISO 2010All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright officeCase postale 56 • CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyright@ Web Published in Switzerlandii© ISO 2010 – All rights reservedCopyright International Organization for Standardization --`,,```,,,,````-`-`,,`,,`,`,,`---ISO 8362-6:2010(E)© ISO 2010 – All rights reservediii ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 8362-6 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use .This second edition cancels and replaces the first edition (ISO 8362-6:1992), Clause 2, 6.2 and Table 2 of which have been technically revised.ISO 8362 consists of the following parts, under the general title Injection containers and accessories : ⎯ Part 1: Injection vials made of glass tubing ⎯ Part 2: Closures for injection vials ⎯ Part 3: Aluminium caps for injection vials ⎯ Part 4: Injection vials made of moulded glass ⎯ Part 5: Freeze drying closures for injection vials⎯ Part 6: Caps made of aluminium-plastics combinations for injection vials⎯ Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics partCopyright International Organization for Standardization --`,,```,,,,````-`-`,,`,,`,`,,`---ISO 8362-6:2010(E)iv© ISO 2010 – All rights reservedIntroductionThe materials from which injection containers (including elastomeric closures) are made are suitable primary packaging materials for storing injectable products until they are administered. However, in this part of ISO 8362, caps are not considered as primary packaging materials in direct contact with pharmaceutical preparations.Copyright International Organization for Standardization --`,,```,,,,````-`-`,,`,,`,`,,`---INTERNATIONAL STANDARD ISO 8362-6:2010(E)© ISO 2010 – All rights reserved1Injection containers and accessories —Part 6:Caps made of aluminium-plastics combinations for injection vials1 ScopeThis part of ISO 8362 specifies caps made of aluminium-plastics combinations for injection vials as specified in ISO 8362-1 and ISO 8362-4.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 2768-1, General tolerances — Part 1: Tolerances for linear and angular dimensions without individual tolerance indicationsISO 2768-2, General tolerances — Part 2: Geometrical tolerances for features without individual tolerance indicationsISO 8362-3, Injection containers and accessories — Part 3: Aluminium caps for injection vialsISO 8872:2003, Aluminium caps for transfusion, infusion and injection bottles — General requirements and test methodsISO 10985, Caps made of aluminium-plastics combinations for infusion bottles and injection vials — Requirements and test methods3 Classification of typesCaps shall be classified as follows:⎯ Type ZB: aluminium cap with central opening and plastics component; ⎯ Type ZD: aluminium cap with complete tear-off tab and plastics component.Copyright International Organization for Standardization --`,,```,,,,````-`-`,,`,,`,`,,`---ISO 8362-6:2010(E)2© ISO 2010 – All rights reserved4 Dimensions and tolerances4.1 DimensionsAll cover versions (flat, ring-shaped or others) of caps shall meet the dimensions given in Figure 1 and Table 1.NOTEThe configuration of the cap shown in Figure 1 is informative only.4.2 TolerancesThe tolerances shall be in accordance with ISO 2768-1 and ISO 2768-2.Dimensions in millimetresType ZBType ZDKey1 plastics component 2aluminium cap in accordance with ISO 8362-3 3 score lineFigure 1 — Configuration of cap Table 1 — Dimensions of capDimensions in millimetresd 1d 2a d 3be ch 1 h 2dNominalsize0,10+min.max.min.max.min.max.±0,2min.max.13 13,3 15 16 3 8 6,3 7,3 8,420 20,3 22,2 23,2 6 10 0,168 0,2427,3 8,7 9,8a The diameter d 2shall be agreed upon between the manufacturer and user. It shall not differ from the nominal value by more than±0,25 mm. The extreme limits are given without tolerance.bAfter plastics element removal.c The thickness e shall be agreed upon between the manufacturer and user. It shall not differ from the nominal value by more than ±0,022 mm. The extreme limits are given without tolerance.d The height h 2shall be agreed upon between the manufacturer and user. It shall not differ from the nominal value by more than±0,3 mm. The extreme limits are given without tolerance.Copyright International Organization for Standardization--`,,```,,,,````-`-`,,`,,`,`,,`---ISO 8362-6:2010(E)© ISO 2010 – All rights reserved35 DesignationAluminium-plastics caps shall be designated according to type; the designation shall be expressed as the word “cap”, the number and part of this part of ISO 8362 followed by the type letters, followed by the nominal size of the container.For example, a Type ZD aluminium-plastics cap of nominal size 13 complying with the requirements laid down in this part of ISO 8362 is designated as follows:Cap ISO 8362-6 - ZD - 136 Requirements6.1 General requirements6.1.1The requirements for aluminium caps shall be in accordance with ISO 8362-3.6.1.2 The requirements for plastics components, and the combination between the plastics component and the aluminium cap, shall be in accordance with ISO 10985.6.1.3 Construction elements which penetrate into the interior space of the aluminium cap shall not interfere with the sealing process.6.2 Forces required to remove tab6.2.1The maximum forces required to remove the tab shall comply with Table 2.6.2.2 For incoming control, a minimum value for the tear-off tab removal force shall be agreed between the supplier and user. The injection caps shall also withstand a sterilization process in accordance with ISO 8872:2003, 5.1.Table 2 — Forces required to completely remove plastics component and tear-off tabForces in newtonsNominal sizeForce to remove plastics component(in accordance with ISO 10985)max.Force to remove tear-off tab completely(in accordance with ISO 8872)max. 13 2025 3530 407 PackagingPackaging shall comply with the requirements of ISO 8872.8 MarkingMarking shall be in accordance with ISO 8872 and the designation shall be as specified in Clause 5.Copyright International Organization for Standardization --`,,```,,,,````-`-`,,`,,`,`,,`---ISO 8362-6:2010(E)ICS 11.040.20Price based on 3 pages--`,,```,,,,````-`-`,,`,,`,`,,`---© ISO 2010 – All rights reservedCopyright International Organization for Standardization。