1、 Collection of SANS standards in electronic format (PDF) 1. Copyright This standard is available to staff members of companies that have subscribed to the complete collection of SANS standards in accordance with a formal copyright agreement. This document may reside on a CENTRAL FILE SERVER or INTRA
2、NET SYSTEM only. Unless specific permission has been granted, this document MAY NOT be sent or given to staff members from other companies or organizations. Doing so would constitute a VIOLATION of SABS copyright rules. 2. Indemnity The South African Bureau of Standards accepts no liability for any
3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. ISBN 978-0-626-19690-5 SANS 11137-1:2007Edition 1 ISO 11137-1:2006Edition 1SOUTH AFRICAN NATIONAL STANDARD Sterilization of health care products Radiatio
4、n Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices This national standard is the identical implementation of ISO 11137-1:2006 and is adopted with the permission of the International Organization for Standardization. Published by Stan
5、dards South Africa 1 dr lategan road groenkloof private bag x191 pretoria 0001 tel: 012 428 7911 fax: 012 344 1568 international code + 27 12 www.stansa.co.za Standards South Africa SANS 11137-1:2007 Edition 1 ISO 11137-1:2006 Edition 1 Table of changes Change No. Date Scope National foreword This S
6、outh African standard was approved by National Committee StanSA SC 5140.37D, Medical devices Sterilization of healthcare products, in accordance with procedures of Standards South Africa, in compliance with annex 3 of the WTO/TBT agreement. This part of SANS 11137 was published in May 2007. This SAN
7、S document supersedes SANS 11137:2006 (edition 1, ISO tech. corr. 1, and ISO amdt 1) in part. 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
8、 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 SANS 11137-1:2007This s tandard may only be used and pri
9、nted by approved subscription and freemailing clients of the SABS .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 licen
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12、o it is found, please inform the Central Secretariat at the address 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 pe
13、rmission in writing from either ISO at the address below or ISOs member 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 Published in Switzerland ii ISO 2006 All rights re
14、servedSANS 11137-1:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11137-1:2006(E) ISO 2006 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 2 3 Terms and definitions. 2 4 Quality ma
15、nagement 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 eff
16、ects 9 5.4 Environmental considerations 10 6 Process and equipment characterization 10 6.1 Process 10 6.2 Equipment . 10 7 Product definition . 11 8 Process definition. 12 8.1 Establishing the maximum acceptable dose . 12 8.2 Establishing the sterilization dose 12 8.3 Specifying the maximum acceptab
17、le dose and the sterilization dose 13 8.4 Transference of maximum acceptable, verification or sterilization dose between radiation sources 13 9 Validation. 14 9.1 Installation qualification. 14 9.2 Operational qualification 14 9.3 Performance qualification 15 9.4 Review and approval of validation 15
18、 10 Routine monitoring and control 16 11 Product release from sterilization. 17 12 Maintaining process effectiveness . 17 12.1 Demonstration of continued effectiveness 17 12.2 Recalibration . 20 12.3 Maintenance of equipment 20 12.4 Requalification of equipment 20 12.5 Assessment of change. 20 Annex
19、 A (informative) Guidance. 21 Bibliography . 36 SANS 11137-1:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11137-1:2006(E) iv ISO 2006 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwi
20、de 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 tha
21、t 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 a
22、ccordance 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 re
23、quires 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 11137-1 was prepared by Tec
24、hnical Committee ISO/TC 198, Sterilization of health care product. This first edition, together with ISO 11137-2 and ISO 11137-3, cancels and replaces ISO 11137:1995. ISO 11137 consists of the following parts, under the general title Sterilization of health care products Radiation: Part 1: Requireme
25、nts for development, validation and routine control of a sterilization process for medical devices Part 2: Establishing the sterilization dose Part 3: Guidance on dosimetric aspects SANS 11137-1:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the S
26、ABS .ISO 11137-1:2006(E) ISO 2006 All rights reserved vIntroduction A sterile medical device is one that is free of viable microorganisms. International Standards, which specify requirements for validation and routine control of sterilization processes, require, when it is necessary to supply a ster
27、ile medical device, that adventitious microbiological contamination of a medical device prior to sterilization be minimized. Even so, medical devices produced under standard manufacturing conditions in accordance with the requirements for quality management systems (see, for example, ISO 13485) may,
28、 prior to sterilization, have microorganisms on them, albeit in low numbers. Such medical devices are non-sterile. The purpose of sterilization is to inactivate the microbiological contaminants and thereby transform the non-sterile medical devices into sterile ones. The kinetics of inactivation of a
29、 pure culture of microorganisms by physical and/or chemical agents used to sterilize medical devices can generally best be described by an exponential relationship between the numbers of microorganisms surviving and the extent of treatment with the sterilizing agent; inevitably this means that there
30、 is always a finite probability that a microorganism may survive regardless of the extent of treatment applied. For a given treatment, the probability of survival is determined by the number and resistance of microorganisms and by the environment in which the organisms exist during treatment. It fol
31、lows that the sterility of any one medical device in a population subjected to sterilization processing cannot be guaranteed and the sterility of a processed population is defined in terms of the probability of there being a viable microorganism present on a medical device. This part of ISO 11137 de
32、scribes requirements that, if met, will provide a radiation sterilization process intended to sterilize medical devices, that has appropriate microbicidal activity. Furthermore, compliance with the requirements ensures that this activity is both reliable and reproducible so that predictions can be m
33、ade, with reasonable confidence, that there is a low level of probability of there being a viable microorganism present on product after sterilization. Specification of this probability is a matter for regulatory authorities and may vary from country to country (see, for example, EN 556-1 and ANSI/A
34、AMI ST67). Generic requirements of the quality management system for design and development, production, installation and servicing are given in ISO 9001 and particular requirements for quality management systems for medical device production are given in ISO 13485. The standards for quality managem
35、ent systems recognise that, for certain processes used in manufacturing, the effectiveness of the process cannot be fully verified by subsequent inspection and testing of the product. Sterilization is an example of such a process. For this reason, sterilization processes are validated for use, the p
36、erformance of the sterilization process is monitored routinely and the equipment is maintained. Exposure to a properly validated, accurately controlled sterilization process is not the only factor associated with the provision of reliable assurance that the products are sterile and, in this regard,
37、suitable for its intended use. Attention is therefore given to a number of considerations including: a) the microbiological status of incoming raw materials and/or components; b) the validation and routine control of any cleaning and disinfection procedures used on the product; c) the control of the
38、 environment in which the product is manufactured, assembled and packaged; d) the control of equipment and processes; e) the control of personnel and their hygiene; f) the manner and materials in which the product is packaged; g) the conditions under which product is stored. SANS 11137-1:2007This s
39、tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11137-1:2006(E) vi ISO 2006 All rights reservedThis part of ISO 11137 describes the requirements for ensuring that the activities associated with the process of radiation sterilization are performe
40、d properly. These activities are described in documented work programmes designed to demonstrate that the radiation process will consistently yield sterile products on treatment with doses falling within the predetermined limits. The requirements are the normative parts of this part of ISO 11137 wit
41、h which compliance is claimed. The guidance given in the informative annexes is not normative and is not provided as a checklist for auditors. The guidance provides explanations and methods that are regarded as being a suitable means for complying with the requirements. Methods other than those give
42、n in the guidance may be used, if they are effective in achieving compliance with the requirements of this part of ISO 11137. The development, validation and routine control of a sterilization process comprise a number of discrete but interrelated activities; e.g. calibration, maintenance, product d
43、efinition, process definition, installation qualification, operational qualification and performance qualification. While the activities required by this part of ISO 11137 have been grouped together and are presented in a particular order, this part of ISO 11137 does not require that the activities
44、be performed in the order that they are presented. The activities required are not necessarily sequential, as the programme of development and validation may be iterative. It is possible that performing these different activities will involve a number of separate individuals and/or organizations, ea
45、ch of whom undertake one or more of these activities. This part of ISO 11137 does not specify the particular individuals or organizations to carry out the activities. SANS 11137-1:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .INTERNATIO
46、NAL STANDARD ISO 11137-1:2006(E) ISO 2006 All rights reserved 1Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices 1 Scope 1.1 This part of ISO 11137 specifies requirements for the develop
47、ment, validation and routine control of a radiation sterilization process for medical devices. NOTE Although the scope of this part of ISO 11137 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment. This part of ISO 111
48、37 covers radiation processes employing irradiators using, a) the radionuclide 60Co or 137Cs, b) a beam from an electron generator or c) a beam from an X-ray generator. 1.2 This part of ISO 11137 does not specify requirements for development, validation and routine control of a process for inactivat
49、ing the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. NOTE See, for example, ISO 22442-1, ISO 22442-2 and ISO 22442-3. 1.2.1 This part of ISO 11137 does not detail specified requirements for designating a medical device as sterile. NOTE Attention is drawn to regional and national requirements for des
