ImageVerifierCode 换一换
格式:PDF , 页数:56 ,大小:478.80KB ,
资源ID:591279      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-591279.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(CAN CSA-Z11137-2007 Sterilization of health care products Radiation Part 1 Requirements for development validation and routine control of a sterilization process for medical devi.pdf)为本站会员(ideacase155)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!

CAN CSA-Z11137-2007 Sterilization of health care products Radiation Part 1 Requirements for development validation and routine control of a sterilization process for medical devi.pdf

1、 Reference numberISO 11137-1:2006(E)ISO 2006INTERNATIONAL STANDARD ISO11137-1First edition2006-04-15Sterilization of health care products Radiation Part 1: Requirements for development, validationand routine control of a sterilization process for medical devices Strilisation des produits de sant Irr

2、adiation Partie 1: Exigences relatives la mise au point, la validation et au contrle de routine dun procd de strilisation pour les dispositifs mdicaux National Standard of CanadaCAN/CSA-Z11137-1-07(ISO 11137-1:2006)International Standard ISO 11137-1:2006 (first edition, 2006-04-15) has bee n adopted

3、 withoutmodification (IDT) as CSA Standard CAN/CSA-Z11137-1-07, which has been approved as a National Standardof Canada by the Standards Council of Canada.ISBN 1-55436-449-3 March2007Legal Notice for StandardsCanadian Standards Association (CSA) standards are developed through a consensus standards

4、development process approved by the Standards Council of Canada. This process brings together volunteers representing varied viewpoints and interests to achieve consensus and develop a standard. Although CSA administers the process and establishes rules to promote fairness in achieving consensus, it

5、 does not independently test, evaluate, or verify the content of standards.Disclaimer and exclusion of liabilityThis document is provided without any representations, warranties, or conditions of any kind, express or implied, including, without limitation, implied warranties or conditions concerning

6、 this documents fitness for a particular purpose or use, its merchantability, or its non-infringement of any third partys intellectual property rights. CSA does not warrant the accuracy, completeness, or currency of any of the information published in this document. CSA makes no representations or w

7、arranties regarding this documents compliance with any applicable statute, rule, or regulation. IN NO EVENT SHALL CSA, ITS VOLUNTEERS, MEMBERS, SUBSIDIARIES, OR AFFILIATED COMPANIES, OR THEIR EMPLOYEES, DIRECTORS, OR OFFICERS, BE LIABLE FOR ANY DIRECT, INDIRECT, OR INCIDENTAL DAMAGES, INJURY, LOSS,

8、COSTS, OR EXPENSES, HOWSOEVER CAUSED, INCLUDING BUT NOT LIMITED TO SPECIAL OR CONSEQUENTIAL DAMAGES, LOST REVENUE, BUSINESS INTERRUPTION, LOST OR DAMAGED DATA, OR ANY OTHER COMMERCIAL OR ECONOMIC LOSS, WHETHER BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE), OR ANY OTHER THEORY OF LIABILITY, ARISING

9、OUT OF OR RESULTING FROM ACCESS TO OR POSSESSION OR USE OF THIS DOCUMENT, EVEN IF CSA HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INJURY, LOSS, COSTS, OR EXPENSES.In publishing and making this document available, CSA is not undertaking to render professional or other services for or on beha

10、lf of any person or entity or to perform any duty owed by any person or entity to another person or entity. The information in this document is directed to those who have the appropriate degree of experience to use and apply its contents, and CSA accepts no responsibility whatsoever arising in any w

11、ay from any and all use of or reliance on the information contained in this document. CSA is a private not-for-profit company that publishes voluntary standards and related documents. CSA has no power, nor does it undertake, to enforce compliance with the contents of the standards or other documents

12、 it publishes. Intellectual property rights and ownershipAs between CSA and the users of this document (whether it be in printed or electronic form), CSA is the owner, or the authorized licensee, of all works contained herein that are protected by copyright, all trade-marks (except as otherwise note

13、d to the contrary), and all inventions and trade secrets that may be contained in this document, whether or not such inventions and trade secrets are protected by patents and applications for patents. Without limitation, the unauthorized use, modification, copying, or disclosure of this document may

14、 violate laws that protect CSAs and/or others intellectual property and may give rise to a right in CSA and/or others to seek legal redress for such use, modification, copying, or disclosure. To the extent permitted by licence or by law, CSA reserves all intellectual property rights in this document

15、.Patent rightsAttention is drawn to the possibility that some of the elements of this standard may be the subject of patent rights. CSA shall not be held responsible for identifying any or all such patent rights. Users of this standard are expressly advised that determination of the validity of any

16、such patent rights is entirely their own responsibility.Authorized use of this documentThis document is being provided by CSA for informational and non-commercial use only. The user of this document is authorized to do only the following:If this document is in electronic form:.load this document ont

17、o a computer for the sole purpose of reviewing it;.search and browse this document; and.print this document. Limited copies of this document in print or paper form may be distributed only to persons who are authorized by CSA to have such copies, and only if this Legal Notice appears on each such cop

18、y.In addition, users may not and may not permit others to.alter this document in any way or remove this Legal Notice from the attached standard;.sell this document without authorization from CSA; or.make an electronic copy of this document.If you do not agree with any of the terms and conditions con

19、tained in this Legal Notice, you may not load or use this document or make any copies of the contents hereof, and if you do make such copies, you are required to destroy them immediately. Use of this document constitutes your acceptance of the terms and conditions of this Legal Notice.The Canadian S

20、tandards Association (CSA), under whose auspices this National Standard has been produced, was chartered in 1919 and accredited by the Standards Council of Canada to the National Standards system in 1973. It is a not-for-profit, nonstatutory, voluntary membership association engaged in standards dev

21、elopment and certification activities. CSA standards reflect a national consensus of producers and users including manufacturers, consumers, retailers, unions and professional organizations, and governmental agencies. The standards are used widely by industry and commerce and often adopted by munici

22、pal, provincial, and federal governments in their regulations, particularly in the fields of health, safety, building and construction, and the environment. Individuals, companies, and associations across Canada indicate their support for CSAs standards development by volunteering their time and ski

23、lls to CSA Committee work and supporting the Associations objectives through sustaining memberships. The more than 7000 committee volunteers and the 2000 sustaining memberships together form CSAs total membership from which its Directors are chosen. Sustaining memberships represent a major source of

24、 income for CSAs standards development activities. The Association offers certification and testing services in support of and as an extension to its standards development activities. To ensure the integrity of its certification process, the Association regularly and continually audits and inspects

25、products that bear the CSA Mark. In addition to its head office and laboratory complex in Toronto, CSA has regional branch offices in major centres across Canada and inspection and testing agencies in eight countries. Since 1919, the Association has developed the necessary expertise to meet its corp

26、orate mission: CSA is an independent service organization whose mission is to provide an open and effective forum for activities facilitating the exchange of goods and services through the use of standards, certification and related services to meet national and international needs.For further infor

27、mation on CSA services, write toCanadian Standards Association5060 Spectrum Way, Suite 100Mississauga, Ontario, L4W 5N6CanadaThe Standards Council of Canada (SCC) is thecoordinating body of the National StandardsSystem, a coalition of independent, autonomousorganizations working towards the furtherd

28、evelopment and improvement of voluntarystandardization in the national interest.The principal objects of the SCC are to fosterand promote voluntary standardization as a meansof advancing the national economy, benefiting thehealth, safety, and welfare of the public, assistingand protecting the consum

29、er, facilitating domesticand international trade, and furthering internationalcooperation in the field of standards.A National Standard of Canada (NSC) is a standardprepared or reviewed by an accredited Standards Development Organization (SDO) and approved by the SCC according to the requirements of

30、 CAN-P-2. Approval does not refer to the technical content of the standard; this remains the continuing responsibility of the SDO. An NSC reflects a consensus of a number of capable individuals whose collective interests provide, to the greatest practicable extent, a balance of representation of gen

31、eral interests, producers, regulators, users (including consumers), and others with relevant interests, as may be appropriate to the subject in hand. It normally is a standard which is capable of making a significant and timely contribution to the national interest.Those who have a need to apply sta

32、ndards areencouraged to use NSCs. These standards are subjectto periodic review. Users of NSCs are cautionedto obtain the latest edition from the SDO which publishes the standard.The responsibility for approving standards as National Standards of Canada rests with theStandards Council of Canada270 A

33、lbert Street, Suite 200Ottawa, Ontario, K1P 6N7CanadaCette Norme nationale du Canada est offerte en anglais et en franais.Although the intended primary application of this Standard is stated in its Scope, it is importantto note that it remains the responsibility of the users to judge its suitability

34、 for their particular purpose.Registered trade-mark of Canadian Standards AssociationApproved byStandards Council of CanadaNational Standard of CanadaPublished in March 2007 by Canadian Standards AssociationA not-for-profit private sector organization5060 Spectrum Way, Suite 100, Mississauga, Ontari

35、o, Canada L4W 5N61-800-463-6727 416-747-4044Visit our Online Store at www.ShopCSA.caCAN/CSA-Z11137-1-07Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devicesPrepared byInternational Organizat

36、ion for StandardizationRegistered trade-mark of Canadian Standards AssociationReviewed byCAN/CSA-Z11137-1-07Sterilization of health care products Radiation Part 1: Requirements for development, validation androutine control of a sterilization process for medical devicesMarch 2007 Canadian Standards

37、Association CSA/3CAN/CSA-Z11137-1-07Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devicesCSA PrefaceThis is the first edition of CAN/CSA-Z11137-1, Sterilization of health care products Radia

38、tion Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11137-1 (first edition, 2006-04-15). This Standa

39、rd was reviewed for Canadian adoption by the CSA Technical Committee on Sterilization, under the jurisdiction of the Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. This Standard has been approved as a National Standard of Canada by

40、the Standards Council of Canada.March 2007 Canadian Standards Association 2007All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permission of the publisher. ISO material is reprinted with permission. Where the words “this International Standa

41、rd” appear in the text, they should be interpreted as “this National Standard of Canada”.Inquiries regarding this National Standard of Canada should be addressed toCanadian Standards Association5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4000www.csa.caTo

42、purchase CSA Standards and related publications, visit CSAs Online Store at www.ShopCSA.ca or call toll-free 1-800-463-6727 or 416-747-4044.Blank pageReference numberISO 11137-1:2006(E)ISO 2006INTERNATIONAL STANDARD ISO11137-1First edition2006-04-15Sterilization of health care products Radiation Par

43、t 1: Requirements for development, validationand routine control of a sterilization process for medical devices Strilisation des produits de sant Irradiation Partie 1: Exigences relatives la mise au point, la validation et au contrle de routine dun procd de strilisation pour les dispositifs mdicaux

44、ISO 11137-1:2006(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes 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 dow

45、nloading this file, parties accept therein the responsibility of not infringing Adobes 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 th

46、e 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

47、 given below. ISO 2006 All 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 ISOs me

48、mber body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org ii ISO 2006 All rights reservedISO 11137-1:2006(E) ISO 2006 All rights reserved iiiContents Page Foreword iv Introduc

49、tion v 1 Scope . 1 2 Normative references . 2 3 Terms and definitions. 2 4 Quality management system elements 8 4.1 Documentation 8 4.2 Management responsibility . 9 4.3 Product realization 9 4.4 Measurement, analysis and improvement Control of nonconforming product 9 5 Sterilizing agent characterization . 9 5.1 Sterilizing agent 9 5.2 Microbicidal effectiveness . 9 5.3 Material effects 9 5.4 Environmental considerations 10 6 Process

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