EN 1041-2008 医疗器械厂商提供的信息(中英文版)

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Information supplied
by the manufacturer of
medical devices
医疗器械厂商提供的信息
I C S 01.110; 11.040.01; 11.120.01
B R I T I S H S T A N D A R D B S E N
1041:2008
N O COPYING W I T H O U T BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT L A W
B S E N 1041:2008
National foreword
国家前言
This British Standard is the U K implementation of E N 1041:2008. It
supersedes BS E N1041:1998, which will be withdrawn on 3 August 2011.
此英国标准是英国执行的EN1041:2008,取代了英国标准EN 1041:1998,将于
2011年8月3日被孤立。

The U K participation in its preparation was entrusted to Technical
Committee CH/210/3, General terminology and symbols.
A list of organizations represented on this committee can be obtained on request
to its secretary.
This publication does not purport to include all the necessary provisions of
a contract. Users are responsible for its correct application.
Compliance with a British Standard cannot confer immunity from
legal obligations.
英国参与此制定是委托了技术委员会CH/210/3,常规术语和符号。

包括此委员会代表的组织列表,如有需求可询问委员会秘书。

此出版不包括协议中所有必要的规定。

使用者负责正确的应用。

依照英国标准不会协商法律规定的免疫性。

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2008 此英国标准在标准准则和委员会
的授权下于2008年8月31日出版© BSI 2008
I S B N 978 0 580 54661 7 Amendments/corrigenda issued since publication
出版时颁布的修改
Date Comments
EUROPEAN STANDARD
EN 1041 NORME EUROP ÉENNE
EUROP ÄISCHE NORM
August 2008 ICS 01.110; 11.040.01; 11.120.01 Supersedes EN 1041:1998
English version
Information supplied by the manufacturer of medical devices
医疗器械厂商提供的信息
Informations fournies par le fabricant de dispositifs
Bereitstellung von Informationen durch den Hersteller von m édicaux Medizinprodukten
This European Standard was approved by CEN on 4 July 2008.
CEN andCENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN or CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN and/or CENELEC member into its own language and notified to the CEN Management Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees, respectively, of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. CEN Management Centre:
CENELEC Central Secretariat: rue de Stassart, 36 B-1050 Brussels
© 2008 CEN/CENELEC All rights of exploitation in any form
and by any means reserved
BS EN 1041:2008
BS EN 1041:2008
EN 1041:2008 (E)
Contents Page
Foreword (3)
Introduction (4)
1 Scope (5)
2 Normative references (5)
3 Terms and definitions (5)
4 Requirements (6)
4.1 General (6)
4.2 Units, symbols and colours (6)
4.3 Language and country identifiers (7)
4.4 Dates (7)
4.5 Device nomenclature (7)
4.5.1 Identifiers of nomenclature (7)
4.5.2 Device common terms (7)
4.5.3 Batch code; lot number; batch number; lot code (7)
5 Requirements for provision of information (7)
5.1 General (7)
5.2 Specific requirements (8)
5.2.1 Applicability (8)
5.2.2 Accessibility (8)
5.2.3 Legibility (8)
5.2.4 Availability (8)
5.2.5 Security (8)
5.2.6 Changes to information provided (8)
6 Documentation (8)
Annex A (informative) Requirements and guidance for Directives 93/42/EEC and 90/385/EEC, as amended (9)
A.1 Requirements and guidance for medical devices (Directive 93/42/EEC) (9)
A.2 Requirements and guidance for active implantable medical devices (Directive 90/385/EEC) (15)
Annex B (informative) Guidance on alternative labelling for instructions for use (IFU) (19)
B.1 Guidance on alternative labelling for medical devices (Directive 93/42/EEC) (20)
B.2 Guidance on alternative labelling for active implantable medical devices (Directive
90/385/EEC) (21)
Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EC (22)
Annex ZB (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EC (23)
Bibliography (24)
2
BS EN 1041:2008
EN 1041:2008 (E)
Foreword 前言
This document (EN 1041:2008) has been prepared by Technical Committee CEN/CLC TC 3 “Quality management and corresponding general aspects for medical devices”, the secretariat of which is held by NEN.
此文件由技术委员会CEN/CLC TC 3“医疗器械质量管理和相应常规方面”制定,秘书处由NEN担任。

This European Standard EN 1041:2008 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by February 2009 and conflicting national standards shall be withdrawn at the latest by August 2011.
此欧洲标准EN 1041:2008表示了国际标准的状态,最晚在2009年2月前通过出版同样的内容或签注,不一致的国际标准将最晚在2011年8月前被取消。

This document supersedes EN 1041:1998.
此文件代替了EN 1041:1998
This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directives 93/42/EEC and 90/385/EEC, as amended, with the exception of 3.3 and Annex B.
此文件根据欧洲委员会和欧洲自由贸易组织提供的CEN收到的要求进行制定,向EU指示93/42/EEC和90/385/EEC提供了必要的需求,如补偿,除了3.3和附件B。

Annex A provides practical guidance about the implementation of the essential requirements of the applicable Directives.
附件A提供了操作指南,关于可适用指示的必要需求的执行。

For relationship with EU Directives, see informative Annexes ZA and ZB, which are integral parts of this document. 为了EU 指示关系,请见信息的附件ZA和ZB,是此文件的主要部分。

According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
根据CEN/CENELEC国际规定,以下国家的国际标准组织必须执行此欧洲标准:
3
BS EN 1041:2008
EN 1041:2008 (E)
Introduction 介绍
The first edition of this standard was drafted in a period when the Active Implantable Medical Device Directive (AIMDD) (90/385/EEC) and the Medical Device Directive (MDD) (93/42/EEC) were relatively new and the In Vitro Diagnostic Medical Device Directive (IVDD) (98/79/EEC) was not in existence. In addition, at the time the previous edition of this standard was adopted, the established method of providing information on, with, or otherwise in association with a device was by hard copy. Predominantly, this was printed copy on substrates such as paper, card, or plastic.
此标准的第一个版本是在活性可植入医疗器械指示以及医疗器械指示相对新,生物体外植入医疗器械指示不存在。

除此以外,当适应旧版标准时,建立的提供信息的方法,或者相反联合器械是一个硬复制。

有影响的是,此标准被以纸张、卡片或塑料的形式印刷复印
Since the time of approval of the first edition of this standard on 18 January 1998, the MDD and AIMDD have been amended. In addition, other methods of provision of information have become freely available and widely used.
自从1998年1月18日该标准第一版通过时,MDD和AIMDD已经过修改。

除此以外,其他提供信息的方法已开始自由利用并广泛使用。

The intention of this second edition is to make available guidance for manufacturers of medical devices that is appropriate regardless of the means used to disseminate that information as well as to update the requirements to reflect the changes to Directives 90/385/EEC and 93/42/EEC. In this standard, Directives 90/385/EEC and 93/42/EEC refer to the versions amended in 2007. The guidance reflects the desire to take into account different methods of provision of information, and it is intended that it should, as far as possible, be suitable for future methods of provision of information.
此第二版的目的在于为医疗器械厂商制定适用的指南,适当不顾散步信息的方法并更新需求以反映对指示90/385/EEC 和93/42/EEC的修改。

在此标准中,指示90/385/EEC和93/42/EEC涉及2007中修改的翻译。

指南反映的是考虑提供不同信息的方法,并尽可能合适于以后的信息提供方法。

The requirements and guidance will provide manufacturers with appropriate means to ensure that their provision of information is relevant to all intended recipients and is in compliance with the Essential Requirements of the Directives. The requirements may also provide means by which compliance can be tested by regulatory and inspection agencies.
需求和指南将为厂家提供适当方法以确定他们提供的信息对有意收件人有关并顺从于指示的基本需求。

需求也提供测试是否顺从规定和检查指导的方法。

The possibility of providing information by alternative means is foreseen in Directives 93/42/EEC and 90/385/EEC. Annex B provides guidance on alternative labelling.
通过选择提供信息的可能性可在指示9342/EEC和90/385/EEC中预见。

附件B提供关于选择性商标的指南。

4
BS EN 1041:2008
EN 1041:2008 (E)
1 Scope 范围
This standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices. It does not specify the language to be used for such information, nor does it specify the means by which the information is to be supplied. It is also intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on means by which certain requirements can be met. If a manufacturer follows these means, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be supplied.
此标准指定了信息必须由医疗器械厂家提供,并根据相关活性可植入医疗器械的委员会指示90/385/EEC和关于医疗器械的委员会指示93/42/EEC的规定。

This standard does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards (see Bibliography).
此标准不包含生物体外植入医疗器械的信息提供要求,这些包含于商标标准。

NOTE When national transpositions of the Directives specify the means by which information shall be supplied, this standard does not provide derogation from these requirements for that country.
注意当国家变换指示指定信息提供的方法,此标准不向该国家提供源自这些要求的损失。

2 Normative references 标准化参考
The 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.
以下相关的文档对于此文件的运用是不可或缺的。

关于有日期的参考资料,只有引用的内容运用了。

没有日期的内容,运用了最近的参考内容。

EN 980, Symbols for use in the labelling of medical devices
医疗器械商标的符号
EN ISO 3166-1, Codes for the representation of names of countries and their subdivisions - Part 1: Country codes (ISO 3166-1:2006)
各国代理的名称和细分-第一部分:国家代码
ISO 639-1, Codes for the representation of names of languages – Part 1: Alpha-2 Code
代理名称的语言代码-第一部分:2代码
ISO 1000, SI units and recommendations for the use of their multiples and of certain other units
使用他们倍数和其他确定单位的SI单位和建议
ISO 8601, Data elements and interchange formats – Information interchange – Representation of dates and times 日期元素和交换形式-信息交换-日期和时间的表示
CEN/TR 15133, Nomenclature - Collective terms and codes for groups of medical devices
术语-一批医疗器械的集体术语和代码
3 Terms and definitions 项目和定义
For the purposes of this document, the following terms and definitions apply.
为了此文件,使用了以下项目和定义
3.1
batch; lot 批
defined amount of material or a number of devices, including finished product and accessories, that is processed in one process or a series of related processes
定义了材料的数量或器械的数量,包括成品和附件,经过一项生产过程或一系列相关过程。

5
NOTE The defined amount of material or number of devices will normally be associated with a unique statement of conformity to a defined quality specification.
注意定义的材料和器械数量将普遍与定义的质量标准相一致的唯一状态相关联。

3.2
batch code; lot number; batch number; lot code 代码;批号;批数;批代码
unique identifier associated with a single batch or lot (see 3.1)
唯一认同与一批的关联
BS EN 1041:2008
EN 1041:2008 (E)
3.3
alternative labeling 选择性商标
any form of electronically accessible information supplied by the manufacturer (see 3.4) related to a medical device such as CD/DVD-ROM, Internet or other mode
任何形式的厂商提供的可接近电子信息与医疗器械,如CD/DVD-ROM,英特尔或其他方法。

3.4
information supplied by the manufacturer 厂商提供的信息
all material, however provided, relating to the identification, technical description and use of a medical device that is intended to ensure the safe, effective and compliant use of the device
提供的任何材料只要关于定义、技术描述以及医疗器械的使用就是为了确保安全、有效、适应的使用器械。

NOTE Shipping documents and promotional material are excluded from this definition when identification, technical description and use of a medical device are not intended to ensure the safe, effective and compliant use of the device.
注意当定义、技术描述和医疗器械使用不是为了确保安全、有效和适应的使用器械,船运单据和奖励物质就不包括在此定义中。

3.5
medical device 医疗器械
any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
任何器具、仪器、用具、软件、材料或其他物品,无论是单独使用还是结合使用,包括厂商有意制定的特别使用于诊断或治疗目的并对于其适当使用必要的以及厂商有意使用于人类的软件:
diagnosis, prevention, monitoring, treatment or alleviation of disease;
诊断、预防、监管、治疗或疾病缓和
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
诊断、监管、治疗、缓和或补偿受伤或残疾。

investigation, replacement or modification of the anatomy or of a physiological process;
调查、解剖学或生理学过程的取代或修改
control of conception;
概念的控制
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means
没有达到其在药理学、免疫学或新陈代谢方式上对于人体操作的原理,但是通过此方法可有助其功能。

[Council Directive concerning medical devices (93/42/EEC), Article 1, paragraph 2 (a)]
3.6
user
使用者
any person, legal or natural, for whom the information supplied (see 3.4) is intended
任何人,法人或自然人,信息是有意为他们提供的。

4 Requirements
6
需求
4.1 General 普遍
Product information and labelling shall be part of risk management procedures.产品信息和商标是产品管理的一部分风险
NOTE 1 Due consideration should be given to the guidance provided in Annex A.
注意1 指南附件A中必须提供权利思考
NOTE 2 Product-related standards may require additional information to be supplied.
注意2 产品相关标准可能需要提供额外的信息
4.2 Units, symbols and colours 单位、符号和颜色
Units used shall be SI units as specified in ISO 1000 or any other legal units.
单位使用S1单位,根据ISO1000或其他法定单位指定
Symbols and safety-related identification colours shall be explained in the information supplied unless they are taken from harmonized standards, e.g. EN 980.
符号和相关安全的辨认颜色必须在信息中加以注释,除非是出自协调标准。

BS EN 1041:2008
EN 1041:2008 (E) 4.3 Language and country identifiers
语言和国家标识符
If the manufacturer decides to identify the language used in the information provided, for example to indicate to users the appropriate language in a multilingual document, this shall be done using the language codes given in ISO 639-1 and/or the plain text of the language (e.g. “English”).
如果厂家决定识别用于信息中的语言,例如在多种语言文件中向使用者指出合适语言,必须使用ISO 639-1中的语言代号或者语言的纯文本。

If the manufacturer decides to identify the country in the information provided, for example to indicate to users the appropriate customer service contact details for their country, this shall be done using the country codes given in EN ISO 3166-1 and/or the plain name of the country (e.g. “France”).
如果厂家决定识别信息中的国家,例如向使用者指出适合他们国家的客户服务联系方式,使用EN ISO 3166-1中的国家代码或国家简称。

4.4 Dates 日期
Any human-readable date shall be expressed in the format YYYY-MM-DD, YYYY-MM or YYYY, in accordance with ISO 8601.
任何易于人们阅读的日期必须以YYYY-MM-DD, YYYY-MM或YYYY的形式
NOTE The choice of format will be determined by the requirements of the relevant Directives and the specific nature of the devices concerned.
注意选择的格式由相关指示的要求和相关器械的特殊种类所决定
4.5 Device nomenclature 器械术语
4.5.1 Identifiers of nomenclature 术语的标识符
When it is required to include the identification of the generic device group or the device category in the information supplied with the device, this may be done using a nomenclature that is in compliance with EN ISO 15225.
当要求器械的信息中包括普通器械组的鉴定或设备种类时,可能需要使用符合EN ISO 15225的标识符。

NOTE For details of nomenclatures claimed to be in compliance with EN ISO 15225, see the Bibliography.
注意符合EN ISO 15225的具体标识符,请见参考书目。

4.5.2 Device common terms 设备常规项目
When it is appropriate to identify collective terms for medical devices in the information supplied, for example common technology or common materials of construction, this shall be done using the terms and codes set out in CEN/TR 15133.
当信息中为医疗器械提供适当的集体项目确定时,例如普通技术或普通建筑材料,必须使用CEN/TR 15133中的项目和代码。

4.5.3 Batch code; lot number; batch number; lot code 批代码、批号、批数、批代号
These shall consist of alphanumeric characters but may also be presented by other means, for example by using machine-readable codes.
5 Requirements for provision of information
信息提供的需求
5.1 General 常规
7
Any means of provision of information with medical devices shall take into account the intended users, the conditions of use and any issues specific to individual device types that are necessary for the safe and effective use of the device. This shall apply regardless of whether the specific requirements listed below apply to the device. 任何提供的医疗设备信息必须考虑有意使用者、使用状态以及个别设备种类的特殊问题,这些对于安全、有效使用设备是必要的。

无论特殊需求例举与否,这些应用于设备的信息都必须适用。

The appropriate way of providing information shall be based on a risk assessment and in line with the training, experience and education of the intended users.
适当的提供信息的途径必须以风险评估为基础并符合培训以及有意使用者的经验和教育。

BS EN 1041:2008
EN 1041:2008 (E)
5.2 Specific requirements 特殊需求
5.2.1 Applicability 适应性
These specific requirements shall be applicable to all devices to the extent that they are applicable to the specific device type concerned and to the means of provision of the relevant information. For example, the requirement to allow for a “use by” date is not applicable to devices that do not bear a “use by” date.
这些特殊要求必须适用于所有器械,以至于适用于相应特殊设备种类以及相关信息提供方法。

例如,需求要虑及到有效期不适用于设备,所以不需要有效期。

5.2.2 Accessibility 可理解性
The information presented with a device shall be accessible to intended users taking into account their age, education, knowledge and training.
设备上显示的信息必须考虑到使用者的年龄、教育程度、知识和培训,使其易懂。

When appropriate, a specific means of provision may be restricted to users to whom it is particularly applicable.
适当时,可能需要向使用者限制规定的特殊方法,因为对于他们是特别适用的。

NOTE This requirement may result in more than one means of provision being necessary.
注意此需求可能导致多余一种的规定成为必要。

5.2.3 Legibility 易理解性
Information intended for visual recognition shall be easily legible when viewed using normal vision, corrected if necessary, taking into account the specific size and conditions of use of the particular device.
当用普通视觉看时,可视的信息必须易懂,必要时可修改,考虑特殊尺寸和特殊设备的使用情况。

5.2.4 Availability 实用性
Information shall be available as long as reasonably necessary, taking the lifetime of the device into consideration. 只要适当必要,信息必须可接受,考虑设备的使用寿命。

5.2.5 Security 安全
As far as practicably possible, the medium of information provision shall be protected from corruption, degradation and deliberate change by those other than the manufacturer, whether malicious or not.
至于实际可能,信息规定的媒介必须受到保护以免腐败,退化,以及被除厂家以外的人进行恶意或非恶意的故意修改。

If the user can readily identify faulty information, for example by virtue of damaged labels, advice on the action to take shall be provided.
如果使用者能够容易地识别错误信息,例如利用破损的商标,应该提供如何操作的建议。

Where the damage to information is not readily apparent and/or the consequences of damage are not obvious, guidance shall be provided on how to maintain the security of the information and limit any adverse consequences.
如果破坏的信息不显而易见或破坏的结果不明显,应该提供如何保持安全的指南并限制不利结果。

NOTE When appropriate and relevant, manufacturers should consider if there are any preventative measures that can
be taken to maintain information security in relation to customer service.
注意当适当而相关时,厂商必须考虑是否存在预防性措施以保护客户服务的信息安全。

5.2.6 Changes to information provided 提供信息的修改
Any changes to information provided for existing users shall be clearly communicated if they are important for
8
patient safety.
任何对现有使用者提供的信息修改必须清楚的沟通,如果对人生安全重要。

6 Documentation 文件
Documentation relating to information provided shall be maintained in the technical documentation(s) relating to the device(s) that are the subject of the information. This may take the form of a specific section holding all the documentation or, alternatively, references to parts of a larger document where the information may be found, such as a quality manual.
关于提供信息的文件必须保存在有关设备的技术文件内,因为隶属于信息。

需要进行特殊分类,保存所有文件,或选择性的,涉及更大类文件的一部分,信息可能会找不到,如质量手册。

Annex A 附件A
(informative) 信息类
Requirements and guidance for Directives 93/42/EEC and 90/385/EEC, as
amended
指示93/42/EEC和90/385/EEC的需求和指南,如修改
NOTE This annex covers those non-active and active medical devices to which Council Directives 93/42/EEC and
90/385/EEC apply, hereinafter called medical devices.
注意此附件包括委员会指示93/42/EEC和90/385/EEC中应用的非操作和操作医疗器械,以下称为医疗器械。

A.1 Requirements and guidance for medical devices (Directive 93/42/EEC)
NOTE The left-hand column reproduces verbatim the requirements for information to be supplied by the manufacturer from Directive 93/42/EEC concerning Medical Devices given in the Essential Requirements in Annex I. The right hand column gives guidance and further explanation, as appropriate. Where no guidance is given, the Essential Requirements are not reproduced below.
注意左栏逐字复制了指示93/42/EEC中厂家提供的附件I中有关医疗器械的必要需求的需求信息。

右栏是指南和适当的深入解释。

没有指南的地方,必要需求不复制于下方。

Requirements
Information Requirements from the Council Directive concerning Medical Devices given in the Essential Requirements in Annex I
需求
附件1必要需求中委员会指示关于医疗器械的信息需求Guidance
指南
BS EN 1041:2008
EN 1041:2008 (E)
9
General 普通
8.7. The packaging and/or label of the device must distinguish between identical or similar products sold in both sterile and non-sterile condition.
设备的包装和商标必须可区分同类或相似的消毒或未消毒产品In accordance with this standard, sterile devices are identified as such, preferably by the symbols as given
in EN 980 or the word stating this condition. Sterile devices should be prominently labelled by the appropriate symbols as given in EN 980. The definitions of sterile as given in EN 556-1 and EN 556-
2 apply. Where both sterile and non-sterile versions of the same device from the same manufacturer are available in similar packaging and where, in such cases, the non-sterile device could be mistaken as sterile, it may be necessary for the safety of the patient, to provide a prominent statement of non-sterility. The similarity can either originate in the device itself or its packaging.
依照此标准,消毒的设备适当的通过EN 980的符号或开始这个情况的词进行识别。

消毒的设备必须以EN 980中的适当符号明显的标贴。

对消毒的定义使用EN 556-1和EN 556-2中。

同一厂商制造的相同产品的消毒和未消毒翻译对于相似包装都适用,这样,未消毒设备会被误认为已消毒,提供明确的未消毒陈述对于保护病人的安全非常必要。

类似情况可源于设备本身或设备的包装。

10.3. The measurements made by devices with a measuring function must be expressed in legal units conforming to the provisions of Council Directive 80/181/EEC.
使用设备测量功能所做的测量必须以法定单位表示,遵照委员会指示80/181/EEC的规定See 4.2, requirements, of this standard. 见4.2,此标准的需求
11.4.1. The operating instructions for devices emitting radiation must give detailed information as to the nature of the emitted radiation, means of protecting
the patient and user and on ways of avoiding misuse and of eliminating the risks inherent in installation.
设备发射辐射的使用说明书必须有详细的信息,至于发射辐射的种类,保护病人和使用者的途径,避免错误的方法以及安装时固有风险的排除。

Radiation is not limited to ionizing radiation. Other examples of radiation include heat and laser radiation (see also 89/618/Euratom).
辐射不局限于致电离辐射。

其他如热辐射和激光辐射
13. Information supplied by the manufacturer 厂家提供的信息
13.1. Each device must be accompanied by the information needed to use it safely and properly,
taking account of the training and knowledge of the
每个设备必须伴随安全、适当使用的信息,考虑设备培训和知识。

Any information should be made available in a way that is understandable to the intended user and/or 所有信息必须通过适当途径使使用者理解。

BS EN 1041:2008
EN 1041:2008 (E)
Requirements
Information Requirements from the Council
Directive concerning Medical Devices given in the
Essential Requirements in Annex I
需求
附件1必要需求中委员会指示关于医疗器械的信息需求
Guidance 指南
potential users, and to identify the manufacturer. 潜在用户,识别厂商patient. 病人
For complex equipment a user-friendly guide on how
to check and operate the device in an emergency will be of benefit in addition to instructions of use.
至于复杂的设备,除了使用指导外,关于紧急情况下如何检查、操作设备的用户指南是有帮助的。

This information comprises the details on the label and the data in the instructions for use.
此信息包括商标上的详细内容以及使用指导中的数据
As far as practicable and appropriate, the information needed to use the device safely must be set out on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging. If individual packaging of each unit is not practicable, the information must be set out in the leaflet supplied with one or more devices.
至于可行和适当,如何安全使用设备的信息必须标在设备上或每个包装上,或适当的地方,销售标贴上。

如果每个独立包装不可行,则信息必须标在一个或多个设备的传单上。

When instructions for use are provided by means of a leaflet, the number of leaflets in a multiple pack is determined by the manufacturer, taking into consideration the use of the device. Information may also be provided by electronic means (see Annex B).
当使用指导通过传单发行,多样包装的传单数量由厂家决定,需考虑设备的使用。

同时信息由电子方式提供。

Many devices, particularly active devices and many non-active class I devices, will not be supplied with packaging, apart from transit containers. In the absence of suitable packaging, any information should be supplied on labelling, accompanying documentation, or marking of the device, as necessary.
许多设备,尤其是活性设备和许多非活性级别1设备,没有包装,与移动容器分离。

没有合适包装的情况下,信息必须提供在商标上,伴随文档或设备备注,是必要的
Instructions for use must be included in the packaging for every device. By way of exception, no such instructions for use are needed for devices in Class I
or Class IIa if they can be used safely without any
such instructions.
使用指示必须包含在每个设备的包装内。

除此以外,如果没有类似指示时可安全使用,那么级别1或2就不需要类似使用指示。

13.2. Where appropriate, this information should take the form of symbols. Any symbol or identification colour used must conform to harmonized standards. In areas for which no standards exist, the symbols and colours must be described in the documentation supplied with the device. Documentation can be the label and/or instructions for use. See 4.2 requirements, of this standard.
文件可以为商标或使用指示。

此标准见4.2要求
10
适当时,此信息可用符号的形式。

任何使用的符号或识别颜色必须符合协调的标准。

没有标准存在的区域,符号和颜色必须在设备提供的文件中描述。

13.3. The label must bear the following particulars: 商标必须包括以下特殊内容:
National regulations may require the information
referred to in sections 13.3 and 13.6 of Annex I of the medical devices directive to be in their national language(s) or in another Community language when a device reaches the final user, regardless of whether it is for professional or other use (93/42/EEC, Article 4, paragraph 4). The use of symbols that conform to harmonized standards will mean that there is no need to translate certain information.
当设备达到最后使用时,国家规定要求涉及医疗器械指示附件1中13.3和13.6部分的信息以本国语言或其他可沟通语言显示,不考虑是否专业使用或其他使用。

符合协调标准的符号使用意味着没有必要翻译某些信息。

(a) the name or trade name and address of the
manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorized representative where the manufacturer does not have a registered place of business in the Community; 厂商的名称、贸易名称和地址。

至于设备进口到社会上,关注设备对社会的贡献,应包含
商标或外包装或使用指示,另外,授权代表的名称和地址,厂商在社会上没有注册的商业场所。

The full postal addresses may not be necessary if the information is sufficient to contact them, e.g., name or trade name, post code, country. However, the address needs to be sufficient to contact the physical location of the manufacturer and/or the authorized representative, if applicable. The post box alone is not sufficient.
如果信息足够联系他们,那么完整的邮政地址就没必要了。

如,名称或贸易名称、邮政编码、国家。

然而,地址
必须完整以便联系厂商的实际位置或授权代表。

独立的邮
政信箱是不够的。

(b) the details strictly necessary to identify the device and the contents of the packaging especially for the 确实需要详细情况以识别设备
For many devices, the identity will be clearly evident to the intended user. Unpackaged devices, devices with 对于许多设备来说,身份对于使用者是相当明显的。

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