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 978-0-626-20845-5 SANS 11135-1:2008 Edition 1 ISO 11135-1:2007 Edition 1SOUTH AFRICAN NATIONAL STANDARD Sterilization of health care products Ethyle
4、ne oxide 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 11135-1:2007 (corrected version) and is adopted with the permission of the International Organization for Standar
5、dization. Published by Standards 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 This standard may only be used and printed by approved subscription and freemailing clients
6、 of the SABS.SANS 11135-1:2008 Edition 1 ISO 11135-1:2007 Edition 1 Table of changes Change No. Date Scope National foreword This South African standard was approved by National Committee StanSA SC 5140.37D, Medical devices Sterilization of healthcare products, in accordance with procedures of Stand
7、ards South Africa, in compliance with annex 3 of the WTO/TBT agreement. This SANS document was published in April 2008. This SANS document supersedes SABS ISO 11135:1994 (first edition). This standard may only be used and printed by approved subscription and freemailing clients of the SABS. Referenc
8、e number ISO 11135-1:2007(E) ISO 2007INTERNATIONAL STANDARD ISO 11135-1 First edition 2007-05-01 Corrected version 2007-11-01 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices Stril
9、isation des produits de sant Oxyde dthylne Partie 1: Exigences de dveloppement, de validation et de contrle de routine dun processus de strilisation pour des dispositifs mdicaux SANS 11135-1:2008This standard may only be used and printed by approved subscription and freemailing clients of the SABS.I
10、SO 11135-1:2007(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 down
11、loading 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 the
12、 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
13、given below. COPYRIGHT PROTECTED DOCUMENT ISO 2007 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
14、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 2007 All rights reservedSANS 11135-1:2008This standard ma
15、y only be used and printed by approved subscription and freemailing clients of the SABS.ISO 11135-1:2007(E) ISO 2007 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 2 3 Terms and definitions. 2 4 Quality management systems . 9 4.1 Documentation 9
16、 4.2 Management responsibility . 9 4.3 Product realization 9 4.4 Measurement, analysis and improvement Control of nonconforming product 10 5 Sterilizing agent characterization . 10 5.1 Sterilizing agent 10 5.2 Microbicidal effectiveness . 10 5.3 Material effects 10 5.4 Environmental considerations 1
17、0 6 Process and equipment characterization 10 6.1 Process characterization . 10 6.2 Equipment characterization. 11 7 Product definition . 12 7.1 General. 12 7.2 Product safety and performance. 12 7.3 Microbiological quality. 12 7.4 Documentation 13 8 Process definition. 13 9 Validation. 14 9.1 Insta
18、llation qualification. 14 9.2 Operational qualification 14 9.3 Performance qualification 14 9.4 Varying load configurations 16 9.5 Review and approval of validation 16 10 Routine monitoring and control 18 11 Product release from sterilization. 19 12 Maintaining process effectiveness . 19 12.1 Genera
19、l. 19 12.2 Maintenance of equipment 19 12.3 Requalification 19 12.4 Assessment of change. 20 Annex A (normative) Determination of lethal rate of the sterilization process Biological indicator/bioburden approach. 21 Annex B (normative) Conservative determination of lethal rate of the sterilization pr
20、ocess Overkill approach 23 Annex C (informative) General guidance. 25 Bibliography . 41 SANS 11135-1:2008This standard may only be used and printed by approved subscription and freemailing clients of the SABS.ISO 11135-1:2007(E) iv ISO 2007 All rights reservedForeword ISO (the International Organiza
21、tion 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
22、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. In
23、ternational 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. Publi
24、cation 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 r
25、ights. ISO 11135-1 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. ISO 11135 consists of the following parts, under the general title Sterilization of health care products Ethylene oxide: Part 1: Requirements for development, validation and routine control of a
26、 sterilization process for medical devices Part 2: Guidance on the application of ISO 11135-1 ISO 11135-1, together with ISO 11135-2, cancels and replaces ISO 11135:1994 and ISO 11135-4/Cor. 1:1994, which have been technically revised. This corrected version of ISO 11135-1:2007 includes the followin
27、g corrections: page iv, Foreword: the sentence “ISO 11135-1, together with ISO 11135-2, cancels and replaces . technically revised.” has been added. SANS 11135-1:2008This standard may only be used and printed by approved subscription and freemailing clients of the SABS.ISO 11135-1:2007(E) ISO 2007 A
28、ll rights reserved v Introduction A sterile medical device is one that is free of viable microorganisms. International Standards that specify requirements for validation and routine control of sterilization processes, require, when it is necessary to supply a sterile medical device, that adventitiou
29、s 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, prior to sterilization, have microorg
30、anisms 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 pure culture of microorganisms by phy
31、sical 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 ethylene oxide; inevitably this means that there is always a finite probability that a mi
32、croorganism 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 follows that the sterility of any one medica
33、l 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 11135 describes requirements that, if met, will p
34、rovide an ethylene oxide sterilization process intended to sterilize medical devices, which has appropriate microbicidal activity. Furthermore, compliance with the requirements ensures that this activity is both reliable and reproducible so that it can be predicted, with reasonable confidence, that
35、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/AAMI ST67). Generic requirements of the q
36、uality management systems 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 management systems recognise that, for certain
37、 processes used in manufacturing or reprocessing, 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 performance of the steri
38、lization process monitored routinely and the equipment maintained. Exposure to a properly validated, accurately controlled sterilization process is not the only factor associated with the provision of reliable assurance that the product is sterile and, in this regard, suitable for its intended use.
39、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 environment in which the produ
40、ct is manufactured or reprocessed, 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 11135-1:2008This standard may only
41、be used and printed by approved subscription and freemailing clients of the SABS.ISO 11135-1:2007(E) vi ISO 2007 All rights reservedThe type of contamination on a product to be sterilized varies and this impacts upon the effectiveness of a sterilization process. Products that have been used in a hea
42、lth care setting and are being presented for resterilization in accordance with the manufacturers instructions (see ISO 17664) should be regarded as a special case. There is the potential for such products to possess a wide range of contaminating microorganisms and residual inorganic and/or organic
43、contamination in spite of the application of a cleaning process. Hence, it is important to pay particular attention to the validation and control of the cleaning and disinfection processes used during reprocessing. The requirements are the normative parts of this part of ISO 11135 with which complia
44、nce 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 suitable means for complying with the requirements. Methods other than those given in the guidance
45、 may be used if they are effective in achieving compliance with the requirements of this part of ISO 11135. The development, validation and routine control of a sterilization process comprises a number of discrete but interrelated activities; e.g. calibration, maintenance, product definition, proces
46、s definition, installation qualification, operational qualification and performance qualification. While the activities required by this part of ISO 11135 have been grouped together and are presented in a particular order, this part of ISO 11135 does not require that the activities be performed in t
47、he order in which 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, each of whom un
48、dertakes one or more of these activities. This part of ISO 11135 does not specify the particular individuals or organizations to carry out the activities. When determining the suitability of ethylene oxide (EO) for sterilization of medical devices, it is important that patient safety is addressed by
49、 minimizing exposure to residual EO, ethylene chlorohydrin (ECH) and ethylene glycol (EG) during normal product use (see ISO 10993-7). SANS 11135-1:2008This standard may only be used and printed by approved subscription and freemailing clients of the SABS.INTERNATIONAL STANDARD ISO 11135-1:2007(E) ISO 2007 All rights reserved 1 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices 1 Scope This part of I
