SANS 11138-3-2007 Sterilization of health care products - Biological indicators Part 3 Biological indicators for moist heat sterilization processes《保健品消毒 生物指示剂 第3部分 湿热灭菌用生物指示剂》.pdf

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 978-0-626-19419-2 SANS 11138-3:2007Edition 2 ISO 11138-3:2006Edition 2SOUTH AFRICAN NATIONAL STANDARD Sterilization of health care products Biologic

4、al indicators Part 3: Biological indicators for moist heat sterilization processes This national standard is the identical implementation of ISO 11138-3:2006 and is adopted with the permission of the International Organization for Standardization. Published by Standards South Africa 1 dr lategan roa

5、d 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 11138-3:2007 Edition 2 ISO 11138-3:2006 Edition 2 Table of changes Change No. Date Scope National foreword This South African standard was approved

6、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 replaces th

7、e first SABS edition (SABS ISO 11138-3:1995). Reference numberISO 11138-3:2006(E)ISO 2006INTERNATIONAL STANDARD ISO11138-3Second edition2006-07-01Sterilization of health care products Biological indicators Part 3: Biological indicators for moist heat sterilization processes Strilisation des produits

8、 de sant Indicateurs biologiques Partie 3: Indicateurs biologiques pour la strilisation la chaleur humideSANS 11138-3:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11138-3:2006(E) PDF disclaimer This PDF file may contain embedded ty

9、pefaces. 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 not inf

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11、timized 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 specified,

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13、tale 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 11138-3:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11138-

14、3:2006(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 member

15、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 Electr

16、otechnical 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 adopted

17、 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 patent

18、rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 11138-3 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. This second edition cancels and replaces the first edition (ISO 11138-3:1995), which has been technically revise

19、d. 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 processe

20、s Part 4: Biological indicators for dry heat sterilization processes Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes SANS 11138-3:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11138-3

21、: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 proces

22、ses. This part of ISO 11138 gives specific requirements for those biological indicators intended for use in moist heat sterilization processes. The intent of providing requirements in the ISO 11138 series of International Standards is to provide general requirements and requirements for test methods

23、. 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 advised, b

24、ut to provide common requirements for the production of those biological indicators known to be in use today. Standards exist providing requirements for the validation and control of moist heat sterilization (see ISO 17665). NOTE Some countries or regions may have published standards covering requir

25、ements for sterilization or biological indicators. Advice on selection, use and interpretation of results when using biological indicators can be found in ISO 14161. SANS 11138-3:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .INTERNATION

26、AL STANDARD ISO 11138-3:2006(E) ISO 2006 All rights reserved 1Sterilization of health care products Biological indicators Part 3: Biological indicators for moist heat sterilization processes 1 Scope This part of ISO 11138 provides specific requirements for test organisms, suspensions, inoculated car

27、riers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent. Moist heat as the sterilizing agent is defined in this part of ISO 11138 as dry saturated steam. While air-steam mixtures may be used

28、in moist heat sterilization processes, the methods and performance requirements of this part of ISO 11138 might not be applicable for biological indicators used in such processes. NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by ISO 17665. NOTE 2 N

29、ational or regional regulations may provide requirements for work place safety. 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 the re

30、ferenced document (including any amendments) applies. ISO 11138-1:2006, Sterilization of health care products Biological indicators Part 1: General requirements ISO 18472, Sterilization of health care products Biolgical and chemical indicators Test equipment 3 Terms and definitions For the purposes

31、of this document, the terms and definitions given in ISO 11138-1 apply. 4 General requirements The requirements of ISO 11138-1 apply. SANS 11138-3:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11138-3:2006(E) 2 ISO 2006 All rights r

32、eserved5 Test organism 5.1 The test organisms shall be spores of Geobacillus stearothermophilus or other strains of microorganism of demonstrated equivalent performance as required by this part of ISO 11138. NOTE 1 Bacillus stearothermophilus has been reclassified as Geobacillus stearothermophilus.

33、NOTE 2 Geobacillus stearothermophilus ATCC 7953 (NCTC 10007, DSM 22 and CIP 52.81), ATCC 12980 (equivalent to NRRL B-4419), have been found to be suitable. 5.2 If a test organism other than Geobacillus stearothermophilus or Bacillus subtilis ATCC 35021 (5230) is used, the suitability of the resistan

34、ce of that test organism shall be determined. NOTE For processes at less than 121 C, microorganisms such as Bacillus subtilis ATCC 35021 (5230) could be used, particularly in sterilization of heat-sensitive liquids. 6 Suspension The requirements of ISO 11138-1 apply. 7 Carrier and primary packaging

35、7.1 The suitability of the carrier and primary packaging materials for biological indicators for use in moist heat 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:

36、 a) minimum exposure temperature: W 5 C above the manufacturers stated maximum temperature; b) sterilizing agent: dry saturated steam; if the biological indicator is intended for use in a moist heat process not using dry saturated steam, e.g. an air/steam mixture, the appropriate air steam mixture s

37、hould be used and noted as an exception to this part of ISO 11138; c) maximum exposure temperature: as stated by the manufacturer; if not stated by the manufacturer, a temperature of 140 C shall be used; d) exposure time: W 30 min. NOTE These conditions have been selected to represent a realistic ch

38、allenge to the carrier while remaining within the practical limits of a moist heat 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 w

39、ith ISO 11138-1:2006, 6.4. 9.2 The viable 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 1,0 105. SANS 11138-3:2007This s tand

40、ard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11138-3:2006(E) ISO 2006 All rights reserved 39.4 The resistance shall be expressed as the D value in minutes at 121 C. The D value of each batch/lot of biological indicators or inoculated carriers sha

41、ll be stated in minutes to one decimal place at 121 C. 9.5 Suspensions, inoculated carriers or biological indicators containing Geobacillus stearothermophilus spores shall have a D121value of W 1,5 min when tested according to the conditions given in Annex A. Other microorganisms shall have D values

42、 supporting the application. The z value of the test organisms in the suspension, on the inoculated carrier or in the biological indicator shall be determined at not less than three temperatures, in the range of 110 C to 130 C. These data shall be used to calculate the z value, which shall be W 6 C

43、(see Annex B). 9.6 The resistance of a biological indicator may also be indicated by the term FBIOvalue (see 11138-1:2006, 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 standards. 9.7 D val

44、ues are determined according to methods given in Annexes C and D of ISO 11138-1:2006. 9.8 Determination of D value and survival-kill response characteristics requires the use of a resistometer applying the resistometer process parameters (see Annex A). 9.9 The survival-kill window can be calculated

45、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 minimum population and minimum D value requirements specified in this part

46、of ISO 11138, the survival-kill response characteristics are: at 121 C: survival time W 4,5 min and kill time u 13,5 min. SANS 11138-3:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11138-3:2006(E) 4 ISO 2006 All rights reservedAnnex

47、 A (normative) Method for determination of resistance to moist heat sterilization A.1 General This method requires the use of a test apparatus referred to as a resistometer in this part of ISO 11138. The specifications of the resistometer process parameters for moist heat sterilization processes are

48、 provided in ISO 18472. Specific requirements related to the test method are provided in A.2. A.2 Method A.2.1 Load the test samples on to suitable sample holders. A.2.2 Pre-heat the resistometer chamber to the required operating temperature, e.g. 121 C 0,5 C. A.2.3 Place the loaded sample holders i

49、n 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 set point of 4,5 kPa 1 kPa within 2 min. Step 2: Admit steam to the chamber to obtain the required temperature and pressure within 10 s. For the 0 minute exposure time, no steam shall be admitted. Step 3: Maintain these conditions for the required exposure time. Step 4: At the end of the exposure period, evacuate the chamber to 10 kPa