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 978-0-626-19418-5 SANS 11138-2:2007Edition 2 ISO 11138-2:2006Edition 2SOUTH AFRICAN NATIONAL STANDARD Sterilization of health care products Biologic
4、al indicators Part 2: Biological indicators for ethylene oxide sterilization processes This national standard is the identical implementation of ISO 11138-2:2006 and is adopted with the permission of the International Organization for Standardization. Published by Standards South Africa 1 dr lategan
5、 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 11138-2:2007 Edition 2 ISO 11138-2:2006 Edition 2 Table of changes Change No. Date Scope National foreword This South African standard was appro
6、ved 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 11138 was published in April 2007. This SANS edition cancels and replace
7、s the first SABS edition (SABS ISO 11138-2:1994). Reference numberISO 11138-2:2006(E)ISO 2006INTERNATIONAL STANDARD ISO11138-2Second edition2006-07-01Sterilization of health care products Biological indicators Part 2: Biological indicators for ethylene oxide sterilization processes Strilisation des
8、produits de sant Indicateurs biologiques Partie 2: Indicateurs biologiques pour la strilisation loxyde dthylneSANS 11138-2:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11138-2:2006(E) PDF disclaimer This PDF file may contain embedd
9、ed 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 downloading this file, parties accept therein the responsibility of no
10、t 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 General Info relative to the file; the PDF-creation parameters we
11、re 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 given below. ISO 2006 All rights reserved. Unless otherwise specif
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13、e 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 reservedSANS 11138-2:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 1
14、1138-2:2006(E) ISO 2006 All rights reserved iiiForeword ISO (the International Organization 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 me
15、mber body interested in a subject for which a technical committee has been established 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 E
16、lectrotechnical Commission (IEC) on all matters of electrotechnical standardization. International 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 ad
17、opted 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 member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of pa
18、tent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 11138-2 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. This second edition cancels and replaces the first edition (ISO 11138-2:1994), which has been technically r
19、evised. ISO 11138 consists of the following parts, under the general title Sterilization of health care products Biological indicators: Part 1: General requirements Part 2: Biological indicators for ethylene oxide sterilization processes Part 3: Biological indicators for moist heat sterilization pro
20、cesses Part 4: Biological indicators for dry heat sterilization processes Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes SANS 11138-2:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11
21、138-2:2006(E) iv ISO 2006 All rights reservedIntroduction ISO 11138-1 specifies production, labelling, test methods and performance requirements for the manufacture of biological indicators including inoculated carriers and suspensions intended for use in validation and monitoring of sterilization p
22、rocesses. This part of ISO 11138 gives specific requirements for those biological indicators intended for use in ethylene oxide sterilization processes. The intent of providing requirements in the ISO 11138 series of International Standards is to provide general requirements and requirements for tes
23、t methods. This series of International Standards represents the current “state-of-the-art” according to the experts representing manufacturers, users and regulatory authorities involved in developing the standard. The intent is not to promote the use of biological indicators where such use is not a
24、dvised, but rather to provide common requirements for the production of those biological indicators that are known to be in use today. Standards exist providing requirements for the validation and control of ethylene oxide sterilization (see ISO 11135). NOTE Some countries or regions may have publis
25、hed other standards covering requirements for sterilization or biological indicators. Advice on selection, use and interpretation of results when using biological indicators can be found in ISO 14161. SANS 11138-2:2007This s tandard may only be used and printed by approved subscription and freemaili
26、ng clients of the SABS .INTERNATIONAL STANDARD ISO 11138-2:2006(E) ISO 2006 All rights reserved 1Sterilization of health care products Biological indicators Part 2: Biological indicators for ethylene oxide sterilization processes 1 Scope This part of ISO 11138 provides specific requirements for test
27、 organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent
28、gases, at sterilizing temperatures within the range of 29 C to 65 C. NOTE 1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135. NOTE 2 National or regional regulations could provide requirements for work place safety. 2 Normative references Th
29、e 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 the referenced document (including any amendments) applies. ISO 11138-1:2006, Sterilization of health care prod
30、ucts Biological indicators Part 1: General requirements ISO 18472, Sterilization of health care products Biological and chemical indicators Test equipment 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 11138-1 apply. 4 General requirements The requi
31、rements of ISO 11138-1 apply. 5 Test organism 5.1 The test organisms shall be spores of Bacillus atrophaeus, Bacillus subtilis or other strains of microorganisms of demonstrated equivalent performance as required by this part of ISO 11138. NOTE 1 Some strains of Bacillus subtilis have been reclassif
32、ied as Bacillus atrophaeus. NOTE 2 Bacillus atrophaeus ATCC 9372, NCTC 10073, NCIMB 8058, DSM 2277, NRRL B-4418 and CIP 77.18 have been found to be suitable. 5.2 If a test organism other than Bacillus atrophaeus is used, the suitability of the resistance of that test organism shall be determined. SA
33、NS 11138-2:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11138-2:2006(E) 2 ISO 2006 All rights reserved6 Suspension The requirements of ISO 11138-1 apply. 7 Carrier and primary packaging 7.1 The suitability of the carrier and primar
34、y packaging materials for biological indicators for use in ethylene oxide sterilization processes shall be demonstrated in accordance with the requirements of ISO 11138-1:2006, 5.2 and Annex B. 7.2 The exposure conditions for establishing compliance shall be: a) minimum exposure temperature: W 55 C;
35、 b) sterilizing agent: ethylene oxide gas at a concentration not less than 800 mg/l at W 70 % RH; c) maximum exposure temperature: as stated by the manufacturer; d) exposure time: W 6h. NOTE These conditions have been selected to represent a realistic challenge to the carrier while remaining within
36、the practical limits of an ethylene oxide sterilization process. 8 Inoculated carriers and biological indicators The requirements of ISO 11138-1 apply. 9 Population and resistance 9.1 The manufacturer shall state the resistance characteristics in accordance with ISO 11138-1:2006, 6.4. 9.2 The viable
37、 count shall be stated with increments u 0,1 10nper unit (e.g. per ml of suspension, per inoculated carrier or per biological indicator). 9.3 For inoculated carriers and biological indicators, the viable count shall be W 1,0 106. 9.4 The resistance shall be expressed as the D value in minutes at 54
38、C and/or 30 C. The D value of each batch/lot of biological indicators or inoculated carriers shall be stated in minutes to one decimal place at 54 C or 30 C, or at both temperatures. 9.5 Suspensions, inoculated carriers or biological indicators containing Bacillus atrophaeus spores shall have a D va
39、lue of not less than 2,5 min at 54 C and/or not less than 12,5 min at 30 C, when tested according to the conditions in Annex A. Other microorganisms shall have D values supporting the application. 9.6 The resistance of a biological indicator may also be indicated by the term FBIOvalue (see ISO 11138
40、-1:2006, 3.7). The resistance characteristics specified in this part of ISO 11138 and any other part of ISO 11138 apply to the specific test conditions stated in the other parts. 9.7 D values are determined according to methods given in Annexes C and D of ISO 11138-1:2006. SANS 11138-2:2007This s ta
41、ndard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11138-2:2006(E) ISO 2006 All rights reserved 39.8 Determination of D value and survival-kill response characteristics require the use of a resistometer applying the reference resistometer process par
42、ameters (see Annex A). 9.9 The survival-kill window can be calculated using the formulae in ISO 11138-1:2006, Annex E. NOTE This information may be of value to the user when comparing different batches from the same manufacturer. EXAMPLE Using the formulae in ISO 11138-1:2006, Annex E with the minim
43、um population and minimum D value requirements specified in this part of ISO 11138, the survival-kill response characteristics are: at 54 C: survival time not less than 10 min and kill time u 25 min; at 30C: survival time not less than 50 min and kill time u 125 min. SANS 11138-2:2007This s tandard
44、may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11138-2:2006(E) 4 ISO 2006 All rights reservedAnnex A (normative) Method for determination of resistance to ethylene oxide sterilization A.1 General This method requires the use of a test apparatus referre
45、d to as a resistometer in this part of ISO 11138. The specifications of the resistometer process parameters for ethylene oxide sterilization processes are provided in ISO 18472. Specific requirements related to the test method are provided in A.2. A.2 Method A.2.1 Load the samples on to suitable sam
46、ple holders. A.2.2 Preheat the resistometer chamber to the selected testing conditions (30 C or 54 C). A.2.3 Place the loaded sample holders in the chamber, close the chamber and initiate the process cycle. A.2.4 Carry out the following sequence of operations: Step 1: evacuate the chamber to a vacuu
47、m set point of 10 kPa 0,5 kPa. Step 2: admit sufficient water vapour to raise the relative humidity in the chamber to 60 % 10 %. Maintain these conditions for a period of 30 min 1 min. The samples should be allowed to warm to above the dew point prior to injection of water vapour to avoid the potent
48、ial for condensation. Step 3: admit ethylene oxide to the chamber to obtain a concentration of 600 mg/l 30 mg/l within 60 s. For the 0 min exposure time, no ethylene oxide shall be admitted. Step 4: maintain these conditions for the required exposure time 5 s. Step 5: at the end of the exposure peri
49、od, evacuate the chamber to 10 kPa or less within 60 s and then admit filtered air, or an inert gas (such as nitrogen) to ambient pressure. Step 6: repeat step 5 four additional times. Step 7: at the end of the above process, remove the samples from the chamber and transfer the samples to the growth medium and incubate (see ISO 11138-1:2006, Clause 7). A.2.5 The transfer period should be documented and the same time period should be used for all tests. A.3 Determi
