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 978-0-626-19417-8 SANS 11138-1:2007Edition 2 ISO 11138-1:2006Edition 2SOUTH AFRICAN NATIONAL STANDARD Sterilization of health care products Biologic
4、al indicators Part 1: General requirements This national standard is the identical implementation of ISO 11138-1:2006 and is adopted with the permission of the International Organization for Standardization. Published by Standards South Africa 1 dr lategan road groenkloof private bag x191 pretoria 0
5、001 tel: 012 428 7911 fax: 012 344 1568 international code + 27 12 www.stansa.co.za Standards South Africa SANS 11138-1:2007 Edition 2 ISO 11138-1:2006 Edition 2 Table of changes Change No. Date Scope National foreword This South African standard was approved by National Committee StanSA SC 5140.37D
6、, 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 11138 was published in April 2007. This SANS edition cancels and replaces the first SABS edition (SABS ISO 11138-1:1
7、994). Reference numberISO 11138-1:2006(E)ISO 2006INTERNATIONAL STANDARD ISO11138-1Second edition2006-07-01Sterilization of health care products Biological indicators Part 1: General requirements Strilisation des produits de sant Indicateurs biologiques Partie 1: Exigences gnrales SANS 11138-1:2007Th
8、is s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11138-1:2006(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 t
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11、ikely event that a problem relating to 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 p
12、hotocopying and microfilm, without permission 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
13、Switzerland ii ISO 2006 All rights reservedSANS 11138-1:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11138-1:2006(E) ISO 2006 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 1.1 General. 1 1.2 Exclusions
14、 . 1 2 Normative references . 1 3 Terms and definitions. 2 4 General manufacturing requirements. 4 4.1 Manufacturing controls 4 4.2 Test organism . 5 4.3 Information supplied by manufacturer (labelling). 6 4.4 Storage and transport 6 5 Specific manufacturing requirements 7 5.1 Suspensions 7 5.2 Carr
15、ier, primary and secondary packaging . 7 5.3 Inoculated carrier 8 5.4 Biological indicators. 8 5.5 Self-contained biological indicators. 8 6 Determination of resistance 8 6.1 General resistance requirements 8 6.2 Test organism . 9 6.3 Population of test organisms 9 6.4 Resistance characteristics 9 6
16、.5 Test conditions . 10 7 Culture conditions 10 7.1 Incubator 10 7.2 Growth medium. 10 7.3 Incubation 10 Annex A (normative) Determination of viable count 11 Annex B (normative) Determination of growth inhibition by carriers and primary packaging materials exposed to sterilization processes 13 Annex
17、 C (normative) D value determination by survivor curve method 15 Annex D (normative) D value determination by fraction negative method 19 Annex E (normative) Survival-kill response characteristics . 35 Annex F (informative) Relationship between components of biological indicators . 36 Bibliography .
18、 37 SANS 11138-1:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11138-1:2006(E) iv ISO 2006 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (
19、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 that committee. International organizations, go
20、vernmental 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 accordance with the rules given in the ISO/IE
21、C 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 requires approval by at least 75 % of the memb
22、er 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 11138-1 was prepared by Technical Committee ISO/TC 198, Sterilization o
23、f health care products. This second edition cancels and replaces the first edition (ISO 11138-1:1994), which has been technically revised. ISO 11138 consists of the following parts, under the general title Sterilization of health care products Biological indicators: Part 1: General requirements Part
24、 2: Biological indicators for ethylene oxide sterilization processes Part 3: Biological indicators for moist heat sterilization processes Part 4: Biological indicators for dry heat sterilization processes Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processe
25、s SANS 11138-1:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11138-1:2006(E) ISO 2006 All rights reserved vIntroduction This part of ISO 11138 specifies general requirements for production, labelling, test methods and performance re
26、quirements for the manufacture of biological indicators including inoculated carriers and suspensions intended for use in validation and monitoring of sterilization processes. Subsequent parts of ISO 11138 provide additional specific requirements for biological indicators for defined sterilization p
27、rocesses. A graphic description of a biological indicator and its components is presented in Annex F. The presentation includes the two types of biological indicator which are covered by ISO 11138. This shows that inoculated carriers can be presented directly to the sterilizing agent without prior p
28、ackaging, or included in a primary package that permits access by the sterilizing agent. The resistance characteristics depend on the type of test organism, its numbers, the method of preparation and the effects of the primary package. Advice on selection, use and interpretation of results of biolog
29、ical indicators can be found in ISO 141617. For any individual sterilization process, including those covered in subsequent parts of ISO 11138, the resistance of the biological indicator will also depend on its microenvironment during testing. In theory, this could lead to an infinite variation in t
30、he preparation of biological indicators. Moreover, a sterilization process could be manipulated in infinite variety to suit each possible set of conditions to which products could be exposed. It has therefore been routine practice to manufacture biological indicators that, when exposed to a set of c
31、onditions in a defined sterilization process, provide resistance characteristics expressed as D values and, where relevant, z values. Such values are set out in the subsequent parts of ISO 11138. ISO 11138, parts 1 to 5 represent the current “state-of-the-art” according to the experts representing m
32、anufacturers, users and regulatory authorities involved in developing this International Standard. Biological indicators for specific sterilization processes not covered by reference test conditions in subsequent parts of ISO 11138 should comply with the general requirements in this part, including
33、the resistance testing procedures. Such biological indicators might not be well enough described, or might be used for novel sterilization processes, or might be represented by isolated bioburden microorganisms. If microorganisms other than risk group 1 (WHO,199327) are included in these biological
34、indicators, the appropriate containment and safety levels must be met. Standards exist providing requirements for the validation and control of sterilization processes (see Bibliography). NOTE Some countries or regions might have published other standards covering requirements for sterilization or b
35、iological indicators (see Bibliography). SANS 11138-1:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .SANS 11138-1:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .INTERNATIONAL
36、 STANDARD ISO 11138-1:2006(E) ISO 2006 All rights reserved 1Sterilization of health care products Biological indicators Part 1: General requirements 1 Scope 1.1 General 1.1.1 This part of ISO 11138 provides general requirements for production, labelling, test methods and performance characteristics
37、of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes. 1.1.2 This part of ISO 11138 specifies basic and common requirements that are applicable to all subsequent parts of ISO 11138
38、. Requirements for biological indicators for particular specified processes are provided in the subsequent parts of ISO 11138. If no specific subsequent part is provided, this part applies. NOTE National or regional regulations may apply. 1.2 Exclusions This part of ISO 11138 does not apply to micro
39、biological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This part of ISO
40、11138, however, could contain elements relevant to such microbiological test systems. 2 Normative references 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
41、the referenced document (including any amendments) applies. ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times ISO 11135:1994, Medical devices Validation and routine control of ethylene oxide sterilization ISO 11137-1, Sterilization of health ca
42、re products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO 11137-2, Sterilization of health care products Radiation Part 2: Establishing the sterilization dose ISO 11137-3, Sterilization of health care products Radiat
43、ion Part 3: Guidance on dosimetric aspects ISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems SANS 11138-1:2007This s tandard may only be used and printed by approved subscription and freemailing clients
44、of the SABS .ISO 11138-1:2006(E) 2 ISO 2006 All rights reservedISO 11607-2, Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes ISO 11737-1, Sterilization of medical devices Microbiological methods Part 1: Determination of a
45、 population of microorganisms on products ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes ISO 15223, Symbols to be used with medical device labels, labelling and information to be supplied ISO 17665-1, Sterilization of health care products Moist heat Part 1
46、: Requirements for the development, validation and routine control of a sterilization process for medical devices ISO 18472, Sterilization of health care products Biological and chemical indicators Test equipment 3 Terms and definitions For the purposes of this document, the following terms and defi
47、nitions apply. 3.1 biological indicator test system containing viable microorganisms providing a defined resistance to a specified sterilization process ISO/TS 11139, definition 2.3 3.2 carrier supporting material on or in which test microorganisms are deposited 3.3 colony forming unit CFU individua
48、l visible units of growth of microorganisms arising from a single cell or multiple cells 3.4 culture collection number unique identification of the test organism allocated by a scientifically recognised service culture collection 3.5 culture conditions combination of growth media and manner of incub
49、ation used to promote germination, growth and/or multiplication of microorganisms NOTE The manner of incubation may include the temperature, time and any other conditions specified for incubation. ISO/TS 11139, definition 2.10 3.6 D value D10value time or dose required to achieve inactivation of 90 % of a population of the test microorganism under stated dose conditions ISO/TS 11139, definition 2.11 SANS 11138-1:2007This s tandard may only be used and printed by approved subscript
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