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 978-0-626-19692-9 SANS 11137-3:2007Edition 1 ISO 11137-3:2006Edition 1SOUTH AFRICAN NATIONAL STANDARD Sterilization of health care products Radiatio
4、n Part 3: Guidance on dosimetric aspects This national standard is the identical implementation of ISO 11137-3:2006 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 000
5、1 tel: 012 428 7911 fax: 012 344 1568 international code + 27 12 www.stansa.co.za Standards South Africa SANS 11137-3:2007 Edition 1 ISO 11137-3:2006 Edition 1 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 11137 was published in May 2007. This SANS document supersedes SANS 11137:2006 (edition 1, ISO tech. corr. 1, and ISO
7、amdt 1) in part. Reference numberISO 11137-3:2006(E)ISO 2006INTERNATIONAL STANDARD ISO11137-3First edition2006-04-15Sterilization of health care products Radiation Part 3: Guidance on dosimetric aspects Strilisation des produits de sant Irradiation Partie 3: Directives relatives aux aspects dosimtri
8、ques SANS 11137-3:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11137-3:2006(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 no
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13、ww.iso.org Published in Switzerland ii ISO 2006 All rights reservedSANS 11137-3:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11137-3:2006(E) ISO 2006 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Nor
14、mative references . 1 3 Terms and definitions. 1 4 Measurement of dose. 1 5 Selection and calibration of dosimetry systems . 2 5.1 General. 2 5.2 Selection of dosimetry systems 2 5.3 Calibration of dosimetry system . 2 6 Establishing the maximum acceptable dose . 2 7 Establishing the sterilization d
15、ose 3 8 Installation qualification. 4 9 Operational qualification 4 9.1 General. 4 9.2 Gamma irradiators 5 9.3 Electron beam irradiators 6 9.4 X-ray irradiators 7 10 Performance qualification 8 10.1 General. 8 10.2 Gamma and X-ray . 9 10.3 Electron beam . 10 11 Routine monitoring and control 11 11.1
16、 General. 11 11.2 Frequency of dose measurements . 11 Annex A (informative) Mathematical modelling 12 Bibliography . 15 SANS 11137-3:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11137-3:2006(E) iv ISO 2006 All rights reservedForewo
17、rd 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 body interested in a subject for which a technic
18、al 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 Electrotechnical Commission (IEC) on all matters of el
19、ectrotechnical 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 by the technical committees are circulated to t
20、he 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 rights. ISO shall not be held responsible for id
21、entifying any or all such patent rights. ISO 11137-3 was prepared by Technical Committee ISO/TC 198, Sterilization of health care product. This first edition, together with ISO 11137-1 and ISO 11137-2, cancels and replaces ISO 11137:1995. ISO 11137 consists of the following parts, under the general
22、title Sterilization of health care products Radiation: Part 1: Requirements 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 11137-3:2007This s tandard may only be us
23、ed and printed by approved subscription and freemailing clients of the SABS .ISO 11137-3:2006(E) ISO 2006 All rights reserved vIntroduction An integral part of radiation sterilization is the ability to measure dose. Dose is measured during all stages of development, validation and routine monitoring
24、 of the sterilization process. It has to be demonstrated that dose measurement is traceable to a national or International Standard, that the uncertainty of measurement is known, and that the influence of temperature, humidity and other environmental considerations on dosimeter response is known and
25、 taken into account. Process parameters are established and applied based on dose measurements. This part of ISO 11137 provides guidance on the application of dose measurements (dosimetry) during all stages of the sterilization process. ISO 11137-1 describes requirements that, if met, will provide a
26、 radiation sterilization process, intended to sterilize medical devices, which has appropriate microbicidal activity. Furthermore, compliance with the requirements helps ensure that this activity is both reliable and reproducible so that predictions can be made, with reasonable confidence, that ther
27、e is a low level of probability of there being a viable microorganism present on product after sterilization. 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 managem
28、ent systems for medical device production are given in ISO 13485. The standards for quality management systems recognize that, for certain processes used in manufacturing or reprocessing, the effectiveness of the process cannot be fully verified by subsequent inspection and testing of the product. S
29、terilization is an example of such a process. For this reason, sterilization processes are validated for use, the performance of the sterilization process monitored routinely and the equipment maintained. Requirements in regard to dosimetry are given in ISO 11137-1 and ISO 11137-2. This part of ISO
30、11137 gives guidance to these requirements. The guidance given 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 guidanc
31、e may be used, if they are effective in achieving compliance with the requirements of ISO 11137-1. SANS 11137-3:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .SANS 11137-3:2007This s tandard may only be used and printed by approved subsc
32、ription and freemailing clients of the SABS .INTERNATIONAL STANDARD ISO 11137-3:2006(E) ISO 2006 All rights reserved 1Sterilization of health care products Radiation Part 3: Guidance on dosimetric aspects 1 Scope This part of ISO 11137 gives guidance on the requirements in ISO 11137 parts 1 and 2 re
33、lating to dosimetry. Dosimetry procedures related to the development, validation and routine control of a radiation sterilization process are described. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the ed
34、ition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 11137-1, Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devi
35、ces ISO 11137-2:2006, Sterilization of health care products Radiation Part 2: Establishing the sterilization dose 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 11137-1, ISO 11137-2 and the following apply. 3.1 dosimetry system interrelated elements
36、 used for determining absorbed dose, including dosimeters, instruments, associated reference standards and procedures for their use ISO/TS 11139:2005 4 Measurement of dose Measurement of absorbed dose in connection with the radiation sterilization of medical devices is expressed in terms of absorbed
37、 dose to water. Dosimetry systems should be calibrated in terms of absorbed dose to water. In this part of ISO 11137, absorbed dose is referred to as dose. SANS 11137-3:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11137-3:2006(E) 2
38、 ISO 2006 All rights reserved5 Selection and calibration of dosimetry systems 5.1 General The dosimetry system(s) used to monitor the irradiation of product has to be capable of providing accurate and precise results over the entire dose range of interest. 5.2 Selection of dosimetry systems 5.2.1 Do
39、simetric measurements are required in sterilization dose establishment, validation and routine control of radiation sterilization; different dosimetry systems might be needed for these different tasks. In dose establishment, for example, the range of doses required for a verification or incremental
40、dose experiment might be outside the recommended (and calibrated) operating range of the dosimetry system used for the measurement of sterilization dose and, in such circumstances, an alternative system would have to be employed. 5.2.2 Guidance on the selection of appropriate dosimetry systems used
41、in radiation sterilization can be found in ISO/ASTM 51261. The properties of individual dosimetry systems and procedures for their use are given in the ISO/ASTM Practices listed in the Bibliography. 5.3 Calibration of dosimetry system 5.3.1 It is a requirement in ISO 11137-1 that dose measurements b
42、e traceable to an appropriate national or International Standard and that their level of uncertainty be known. Consequently, all significant sources of measurement uncertainty should be identified and their magnitudes assessed. 5.3.2 Calibration of dosimetry systems for use in radiation sterilizatio
43、n is a significant activity. The response of most systems is influenced by the conditions of irradiation and measurement (e.g. temperature, humidity, dose rate and interval of time between termination of irradiation and measurement). In addition, the effects of these conditions are often interrelate
44、d and they can vary from batch to batch of dosimeters. Therefore, calibration should be carried out under conditions that match as closely as possible the actual conditions of use. This means that calibration is needed for each radiation facility and it is not acceptable to use the outcome of a cali
45、bration supplied by the dosimeter manufacturer without additional experimental verification of its validity. 5.3.3 A recognized national metrology institute or other calibration laboratory accredited to ISO/IEC 17025, or its equivalent, should be used in order to ensure traceability to a national or
46、 International Standard. A calibration certificate provided by a laboratory not having formal recognition or accreditation will not necessarily be proof of traceability to a national or International Standard and additional documentary evidence will be required. 5.3.4 The ability to make accurate do
47、se measurements depends on the calibration and consistency of performance of the entire dosimetry system. This means that all equipment associated with the measurement procedure, not just the dosimeters, is controlled and its performance verified. 5.3.5 Detailed calibration procedures are given in I
48、SO/ASTM 51261. Information on estimating and reporting uncertainty of measurement can be found in ISO/ASTM 51707. Additional guidance is given in Sharpe and Miller 19. 6 Establishing the maximum acceptable dose 6.1 Testing to establish the maximum acceptable dose must be carried out using product or
49、 samples of materials that have been irradiated to doses greater than those anticipated during actual processing. The value of the maximum dose received during sterilization will be influenced by the characteristics of the irradiator and the loading pattern of the product. Thus, transfer of the process to another irradiator, or a change to the loading pattern, might result in a change to the maximum dose to product. SANS 11137-3:2007This s tandard may only be used and printed by approved subscription and freemailing clie
