ImageVerifierCode 换一换
格式:PDF , 页数:44 ,大小:1.45MB ,
资源ID:724384      下载积分:10000 积分
快捷下载
登录下载
邮箱/手机:
温馨提示:
如需开发票,请勿充值!快捷下载时,用户名和密码都是您填写的邮箱或者手机号,方便查询和重复下载(系统自动生成)。
如填写123,账号就是123,密码也是123。
特别说明:
请自助下载,系统不会自动发送文件的哦; 如果您已付费,想二次下载,请登录后访问:我的下载记录
支付方式: 支付宝扫码支付 微信扫码支付   
注意:如需开发票,请勿充值!
验证码:   换一换

加入VIP,免费下载
 

温馨提示:由于个人手机设置不同,如果发现不能下载,请复制以下地址【http://www.mydoc123.com/d-724384.html】到电脑端继续下载(重复下载不扣费)。

已注册用户请登录:
账号:
密码:
验证码:   换一换
  忘记密码?
三方登录: 微信登录  

下载须知

1: 本站所有资源如无特殊说明,都需要本地电脑安装OFFICE2007和PDF阅读器。
2: 试题试卷类文档,如果标题没有明确说明有答案则都视为没有答案,请知晓。
3: 文件的所有权益归上传用户所有。
4. 未经权益所有人同意不得将文件中的内容挪作商业或盈利用途。
5. 本站仅提供交流平台,并不能对任何下载内容负责。
6. 下载文件中如有侵权或不适当内容,请与我们联系,我们立即纠正。
7. 本站不保证下载资源的准确性、安全性和完整性, 同时也不承担用户因使用这些下载资源对自己和他人造成任何形式的伤害或损失。

版权提示 | 免责声明

本文(EN ISO 11140-1-2014 en Sterilization of health care products - Chemical indicators - Part 1 General requirements《保健产品的消毒 化学指示剂 第1部分 一般要求(ISO 11140-1 2014)》.pdf)为本站会员(terrorscript155)主动上传,麦多课文库仅提供信息存储空间,仅对用户上传内容的表现方式做保护处理,对上载内容本身不做任何修改或编辑。 若此文所含内容侵犯了您的版权或隐私,请立即通知麦多课文库(发送邮件至master@mydoc123.com或直接QQ联系客服),我们立即给予删除!

EN ISO 11140-1-2014 en Sterilization of health care products - Chemical indicators - Part 1 General requirements《保健产品的消毒 化学指示剂 第1部分 一般要求(ISO 11140-1 2014)》.pdf

1、BSI Standards PublicationBS EN ISO 11140-1:2014Sterilization of health careproducts Chemical indicatorsPart 1: General requirementsBS EN ISO 11140-1:2014Incorporating corrigendum January 2015BS EN ISO 11140-1:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN

2、ISO 11140-1:2014. It supersedes BS EN ISO 11140-1:2009 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization of medical devices.A list of organizations represented on this committee can be obtained on request to its secretary.This publi

3、cation does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2015. Published by BSI Standards Limited 2015ISBN 978 0 580 89220 2ICS 11.080.01Compliance with a British Standard cannot confer immunit

4、y from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 2014.Amendments/corrigenda issued since publicationDate Text affected31 January 2015 Implementation of CEN Correction Notice 10 December 2014. Table ZA.1 fir

5、st column updatedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11140-1 November 2014 ICS 11.080.01 Supersedes EN ISO 11140-1:2009English Version Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) Strilisation des produits de sant

6、- Indicateurs chimiques -Partie 1: Exigences gnrales (ISO 11140-1:2014) Sterilisation von Produkten fr die Gesundheitsfrsorge - Chemische Indikatoren - Teil 1: Allgemeine Anforderungen (ISO 11140-1:2014) This European Standard was approved by CEN on 23 August 2014. CEN members are bound to comply wi

7、th 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-CENELEC Mana

8、gement Centre or to any CEN 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 member into its own language and notified to the CEN-CENELEC Management Centre has the same st

9、atus as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Mal

10、ta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CE

11、N All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11140-1:2014 EBS EN ISO 11140-1:2014EN ISO 11140-1:2014 (E) 3 Foreword This document (EN ISO 11140-1:2014) has been prepared by Technical Committee ISO/TC 198 “Sterilization of heal

12、th care products“ in collaboration with Technical Committee CEN/TC 102 “Sterilizers for medical purposes” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by M

13、ay 2015, and conflicting national standards shall be withdrawn at the latest by May 2015. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent righ

14、ts. This document supersedes EN ISO 11140-1:2009. 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 Directive(s). For relationship with EU Directive(s), see informative Annex ZA,

15、which is an integral part of this document. 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, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former

16、 Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11140-1:

17、2014 has been approved by CEN as EN ISO 11140-1:2014 without any modification. BS EN ISO 11140-1:2014EN ISO 11140-1:2014 (E) 3 Foreword This document (EN ISO 11140-1:2014) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products“ in collaboration with Technical Comm

18、ittee CEN/TC 102 “Sterilizers for medical purposes” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by May 2015, and conflicting national standards shall be w

19、ithdrawn at the latest by May 2015. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 11140-1:2009. This

20、 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 Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. According

21、to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Gree

22、ce, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11140-1:2014 has been approved by CEN as EN ISO 11140-1:2014 w

23、ithout any modification. BS EN ISO 11140-1:2014EN ISO 11140-1:2014 (E) 3 Foreword his document (EN ISO 11140-1:2014) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products“ in collaboration with Technical Committee CEN/TC 102 “Sterilizers for medical purposes” the

24、 secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by May 2015, and conflicting national standards shall be withdrawn at the latest by May 2015. Attention is drawn

25、to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 11140-1:2009. This document has been prepared under a mandate given to CE

26、N by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. According to the CEN-CENELEC Internal Regulations, the national s

27、tandards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania

28、, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11140-1:2014 has been approved by CEN as EN ISO 11140-1:2014 without any modification. BS EN ISO 11140-1:2014EN ISO 1

29、1140-1:2014 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EC on medical devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to

30、provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EC on medical devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance w

31、ith the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Dir

32、ective 93/42/EC on medical devices Clause(s)/sub-clause(s) of this prEN ISO 11140-1 Essential Requirements (ERs) of Directive 93/42/EC Qualifying remarks/Notes 5.9 6.2.2 6.4.2 7.2 7.2 release of toxic substances transfer type 1 transfer type. 3 6 test procedure 5.8 g) 5.8 h) 6.2.2 7.3, 1stpart Inter

33、fering substances Safety precautions required during and/or after use Bleed and offset 4.1; 4.2; 5; 6.1; 6.2; 7; 8 8.7 type 1 indicator 5.8 13.1 Instructions for use 5.6, 5.7 13.2 Symbols 5.4, 5.6, 5.7, 5.8 i), 5.8 k) 4 5.2 13.3 a), b) Labelling Classification of indicators Critical variables and st

34、ated values 5.8 j) 13.3 c) Labelling 5.4, 5.6, 5.7, 5.8 i), 5.8 k) 4 5.2 13.3 d) Labelling Classification of indicators Critical variables and stated values 5.8 j) 13.3 e), f), g), h) Labelling, expiry date. BS EN ISO 11140-1:2014EN ISO 11140-1:2014 (E) 4 Annex ZA (informative) Relationship between

35、this European Standard and the Essential Requirements of EU Directive 93/42/EC on medical devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the

36、 New Approach Directive 93/42/EC on medical devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers,

37、within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EC on medical devices Clause(s)/sub-clause(s) of

38、this prEN ISO 11140-1 Essential Requirements (ERs) of Directive 93/42/EC Qualifying remarks/Notes 5.9 6.2.2 6.4.2 7.2 7.2 release of toxic substances transfer type 1 transfer type. 3 6 test procedure 5.8 g) 5.8 h) 6.2.2 7.3, 1stpart Interfering substances Safety precautions required during and/or af

39、ter use Bleed and offset 4.1; 4.2; 5; 6.1; 6.2; 7; 8 8.7 type 1 indicator 5.8 13.1 Instructions for use 5.6, 5.7 13.2 Symbols 5.4, 5.6, 5.7, 5.8 i), 5.8 k) 4 5.2 13.3 a), b) Labelling Classification of indicators Critical variables and stated values 5.8 j) 13.3 c) Labelling 5.4, 5.6, 5.7, 5.8 i), 5.

40、8 k) 4 5.2 13.3 d) Labelling Classification of indicators Critical variables and stated values 5.8 j) 13.3 e), f), g), h) Labelling, expiry date. BS EN ISO 11140-1:2014EN ISO 11140-1:2014 (E) 3 Foreword This document (EN ISO 11140-1:2014) has been prepared by Technical Committee ISO/TC 198 “Steriliz

41、ation of health care products“ in collaboration with Technical Committee CEN/TC 102 “Sterilizers for medical purposes” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at th

42、e latest by May 2015, and conflicting national standards shall be withdrawn at the latest by May 2015. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all suc

43、h patent rights. This document supersedes EN ISO 11140-1:2009. 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 Directive(s). For relationship with EU Directive(s), see informati

44、ve Annex ZA, which is an integral part of this document. 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, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Fi

45、nland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of

46、 ISO 11140-1:2014 has been approved by CEN as EN ISO 11140-1:2014 without any modification. BS EN ISO 11140-1:2014EN ISO 11140-1:2014 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EC on medical devices This European Stan

47、dard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EC on medical devi es. Once this standard is cited in the Official Journal of the Euro

48、pean Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requir

49、ements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EC on medical devices Clause(s)/sub-clause(s) of this prEN ISO 11140-1 Essential Requirements (ERs) of Directive 93/42/EC Qualifying remarks/Notes 5.9 6.2.2 6.4.2 7.2 7.2 release of toxic substances transfer type 1 transfer type. 3 6 test procedure 5.8 g) 5.8 h) 6.2.2 7.3, 1stpart Interfering substances Safety precautions required during and/or after use Bleed and offset 4.1; 4.2; 5; 6.1; 6.2; 7; 8 8.7 type 1 indicator 5.8 1

copyright@ 2008-2019 麦多课文库(www.mydoc123.com)网站版权所有
备案/许可证编号:苏ICP备17064731号-1