1、BRITISH STANDARDBS EN ISO 11137-3:2006Sterilization of health care products Radiation Part 3: Guidance on dosimetric aspectsThe European Standard EN ISO 11137-3:2006 has the status of a British StandardICS 11.080.01g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g5
2、4g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO 11137-3:2006This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 March 2007 BSI 2007ISBN 978 0 580 50366 5National fore
3、wordThis British Standard was published by BSI. It is the UK implementation of EN ISO 11137-3:2006. It supersedes BS EN 552:1994, which will be withdrawn on 1 April 2009.The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization of medical devices.A list of or
4、ganizations represented on CH/198 can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.Am
5、endments issued since publicationAmd. No. Date CommentsEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 11137-3April 2006ICS 11.080.01 Supersedes EN 552:1994 English VersionSterilization of health care products - Radiation - Part 3:Guidance on dosimetric aspects (ISO 11137-3:2006)Strilisation d
6、es produits de sant - Irradiation - Partie 3:Directives relatives aux aspects dosimtriques (ISO 11137-3:2006)Sterilisation von Produkten fr die Gesundheitsfrsorge -Strahlen - Teil 3: Anleitung zu dosimetrischen Aspekten(ISO/FDIS 11137-3:2006)This European Standard was approved by CEN on 13 April 200
7、6.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on a
8、pplication to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has
9、 the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romani
10、a,Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means reservedworldw
11、ide for CEN national Members.Ref. No. EN ISO 11137-3:2006: EForeword This document (EN ISO 11137-3:2006) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products“ in collaboration with Technical Committee CEN/TC 204 “Sterilization of medical devices“, the secretaria
12、t of which is held by BSI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by October 2006, and conflicting national standards shall be withdrawn at the latest by April 2009. This document supersedes
13、 EN 552:1994. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this do
14、cument. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, La
15、tvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 11137-3:2006 has been approved by CEN as EN ISO 11137-3:2006 without any modifications. EN ISO 11137-3:2006Referen
16、ce numberISO 11137-3:2006(E)INTERNATIONAL 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 dosimtriques EN ISO 11137-3:2006ii iiiCo
17、ntents Page Foreword iv Introduction v 1 Scope . 1 2 Normative 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 maximu
18、m acceptable dose . 2 7 Establishing the sterilization dose 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 Elec
19、tron beam . 10 11 Routine monitoring and control 11 11.1 General. 11 11.2 Frequency of dose measurements . 11 Annex A (informative) Mathematical modelling 12 Bibliography . 15 EN ISO 11137-3:2006Relationship between this European Standard and the Essential Requirements of EU Directives 90/385/EEC co
20、ncerning active implantable medimedical devices and 98/79/EEC concerning in vitro diagnostic medical devicesAnnex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directives 90/385/EEC concerning active implantable medical devices, 93/42/EEC concernin
21、g medical devices and 98/79/EEC concerning in vitro diagnostic medical devices.16 iv Foreword 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 thr
22、ough 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, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collabo
23、rates 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/IEC Directives, Part 2. The main task of technical committees is to prepare International Stand
24、ards. 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 member bodies casting a vote. Attention is drawn to the possibility that some of the elements of
25、this document may be the subject of patent rights. ISO shall not be held responsible for identifying 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
26、 and replaces ISO 11137:1995. ISO 11137 consists of the following parts, under the general 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
27、 dose Part 3: Guidance on dosimetric aspects EN ISO 11137-3:2006vIntroduction An integral part of radiation sterilization is the ability to measure dose. Dose is measured during all stages of development, validation and routine monitoring of the sterilization process. It has to be demonstrated that
28、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 taken into account. Process parameters are established and ap
29、plied 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 radiation sterilization process, intended to sterilize medica
30、l 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 there is a low level of probability of there being a viable microo
31、rganism 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 management systems for medical device production are given in ISO 134
32、85. 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. Sterilization is an example of such a process. For this reason,
33、 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 11137 gives guidance to these requirements. The guidance given
34、 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 may be used, if they are effective in achieving compliance w
35、ith the requirements of ISO 11137-1. EN ISO 11137-3:2006blank1Sterilization 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 relating to dosimetry. Dosimetry procedures related to the
36、 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 edition cited applies. For undated references, the latest
37、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 devices ISO 11137-2:2006, Sterilization of health care produ
38、cts 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 used for determining absorbed dose, including dosimeter
39、s, 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 dose to water. Dosimetry systems should be calibrated i
40、n terms of absorbed dose to water. In this part of ISO 11137, absorbed dose is referred to as dose. EN ISO 11137-3:20062 5 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
41、 results over the entire dose range of interest. 5.2 Selection of dosimetry systems 5.2.1 Dosimetric 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 dos
42、e establishment, for example, the range of doses required for a verification or incremental 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
43、 have to be employed. 5.2.2 Guidance on the selection of appropriate dosimetry systems used 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 Calib
44、ration of dosimetry system 5.3.1 It is a requirement in ISO 11137-1 that dose measurements be 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 m
45、agnitudes assessed. 5.3.2 Calibration of dosimetry systems for use in radiation sterilization 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 irra
46、diation and measurement). In addition, the effects of these conditions are often interrelated 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
47、 is needed for each radiation facility and it is not acceptable to use the outcome of a calibration 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/I
48、EC 17025, or its equivalent, should be used in order to ensure traceability to a national or 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
49、 and additional documentary evidence will be required. 5.3.4 The ability to make accurate dose 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 ISO/ASTM 51261. Information on estimating and reporting uncertainty of measurement can be found in ISO/ASTM 51707. Additional guidance is given in Sharpe a
