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1、BRITISH STANDARD BS EN 15424:2007 Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices The European Standard EN 15424:2007 has the status of a British Standard ICS 11.080.01
2、 ? Licensed Copy: London South Bank University, London South Bank University, Mon May 07 12:20:30 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS EN 15424:2007 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2007 BSI 2007 ISBN 978 0 58
3、0 50632 1 National foreword This British Standard was published by BSI. It is the UK implementation of EN 15424:2007. The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization of medical devices. A list of organizations represented on this committee can be ob
4、tained 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. Amendments issued since publication Amd. N
5、o. DateComments Licensed Copy: London South Bank University, London South Bank University, Mon May 07 12:20:30 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 15424 April 2007 ICS 11.080.01 English Version Sterilization of medical devices - Low tempera
6、ture steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices Strilisation des dispositifs mdicaux - Dveloppement, validation et contrle de routine des procds de strilisation - Vapeur deau basse temprature et au formaldhyde
7、Sterilisation von Medizinprodukten - Niedertemperatur- Dampf-Formaldehyd - Anforderungen an die Entwicklung, Validierung und Routineberwachung von Sterilisationsverfahren fr Medizinprodukte This European Standard was approved by CEN on 17 February 2007. CEN members are bound to comply with the CEN/C
8、ENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to
9、any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official version
10、s. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spai
11、n, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2007 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national M
12、embers. Ref. No. EN 15424:2007: E Licensed Copy: London South Bank University, London South Bank University, Mon May 07 12:20:30 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 15424:2007 (E) 2 Contents Page Foreword4 Introduction.5 1 Scope 7 1.1 Inclusions .7 1.2 Exclusions7 2 Normative references8 3
13、 Terms and definitions .8 4 Quality Management System Elements.14 4.1 Documentation.14 4.2 Management responsibility 14 4.3 Product realization.14 4.4 Control of non-conforming product.15 5 Sterilizing agent characterization 15 5.1 General15 5.2 Sterilizing agent.15 5.3 Microbicidal effectiveness15
14、5.4 Material effects.15 5.5 Environmental considerations.15 6 Process and equipment characterization .16 6.1 General16 6.2 Process.16 6.3 Equipment 16 7 Product definition17 8 Process definition18 9 Validation19 9.1 General19 9.2 Installation qualification19 9.2.1 General19 9.2.2 Installation19 9.2.
15、3 Equipment 20 9.3 Operational qualification.20 9.4 Performance qualification.20 9.4.1 General20 9.4.2 Performance qualification physical21 9.4.3 Performance qualification microbiological21 9.4.4 Performance qualification desorption and drying 22 9.5 Review and approval of validation.22 10 Routine m
16、onitoring and control.23 10.1 General23 10.2 Biological indicators .23 10.3 Chemical indicators.23 10.4 Records.23 11 Product release from sterilization24 12 Maintaining process effectiveness24 12.1 General24 12.2 Maintenance of equipment .24 12.3 Requalification.24 12.4 Assessment of change25 Annex
17、 A (normative) Process definition based on inactivation of reference microorganisms and knowledge of bioburden on product items to be sterilized 26 Licensed Copy: London South Bank University, London South Bank University, Mon May 07 12:20:30 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 15424:2007
18、(E) 3 A.1 General .26 A.2 Procedure.26 Annex B (normative) Process definition based on inactivation of reference microorganisms27 B.1 General .27 B.1.1 Overkill approach 27 B.1.2 Penetration characteristics into medical devices27 B.2 Test procedure.28 B.2.1 General .28 B.2.2 Biological indicators.28
19、 B.2.3 Test systems28 B.2.4 Load configuration28 B.2.5 Testing28 Annex C (informative) Guidance on application of this European Standard30 C.1 Scope30 C.2 Normative references30 C.3 Terms and definitions.30 C.4 Quality management system elements.30 C.5 Sterilizing agent characterization30 C.5.1 Neut
20、ralization.30 C.5.2 Studies of microbial inactivation.31 C.6 Process and equipment characterization.31 C.7 Product definition31 C.7.1 General .31 C.7.2 Design considerations for medical devices intended for sterilization 32 C.7.3 Packaging considerations32 C.8 Process definition .32 C.8.1 General .3
21、2 C.8.2 Influence on product and packaging.33 C.8.3 Determination of process effectiveness.33 C.9 Validation34 C.9.1 General .34 C.9.2 Installation qualification (IQ)34 C.9.3 Operational qualification (OQ) .35 C.9.4 Performance qualification (PQ)36 C.9.5 Documentation and approval of validation.37 C
22、.10 Routine monitoring and control.37 C.11 Product release from sterilization .38 C.11.1 General .38 C.11.2 Product release using biological indicators.38 C.11.3 Parametric release.38 C.12 Maintaining process effectiveness38 C.12.1 Change control 38 C.12.2 Requalification.39 Annex D (informative) En
23、vironmental aspects regarding development, validation and routine control of Low Temperature Steam and Formaldehyde processes.40 D.1 General .40 D.2 Formaldehyde (brief description) 40 D.3 Environmental impact of formaldehyde40 D.4 Other environmental burdens41 Annex ZA (informative) Relationship be
24、tween this European Standard and the Essential Requirements of EU Directive 93/42/EEC Medical devices.44 Bibliography45 Licensed Copy: London South Bank University, London South Bank University, Mon May 07 12:20:30 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 15424:2007 (E) 4 Foreword This document
25、 (EN 15424:2007) has been prepared by Technical Committee CEN/TC 204 “Sterilization of medical devices”, the secretariat 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 Oc
26、tober 2007, and conflicting national standards shall be withdrawn at the latest by October 2007. 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 w
27、ith EU Directive(s), see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Repub
28、lic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: London South Bank University, London Sout
29、h Bank University, Mon May 07 12:20:30 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 15424:2007 (E) 5 Introduction A sterile medical device is one which is free of viable microorganisms. European Standards, which specify requirements for validation and routine control of a sterilization process requ
30、ire, when it is necessary to supply a sterile medical device, that adventitious microbiological contamination of a medical device prior to sterilization be minimized. Even so, medical devices produced under standard manufacturing conditions in accordance with the requirements for quality management
31、systems (see EN ISO 13485) or which have been subjected to a cleaning process as part of their reprocessing in a health care establishment may, prior to sterilization, have microorganisms on them, albeit in low numbers. Such products are non-sterile. The purpose of sterilization is to inactivate the
32、 microbiological contaminants and thereby transform the non-sterile products into sterile ones. The kinetics of inactivation of a pure culture of microorganisms by physical and/or chemical agents used to sterilize medical devices can generally best be described by an exponential relationship between
33、 the numbers of microorganisms surviving and the extent of treatment with the sterilizing agent; inevitably this means that there is always a finite probability that a microorganism may survive regardless of the extent of treatment applied. For a given treatment, the probability of survival is deter
34、mined by the number and resistance of microorganisms and by the environment in which the organisms exist during treatment. It follows that the sterility of any one product in a population subjected to sterilization cannot be guaranteed and the sterility of a processed population is defined in terms
35、of the probability of there being a viable microorganism present on a product item. This standard describes requirements which will enable the demonstration that a low temperature steam and formaldehyde sterilization process intended to sterilize medical devices has appropriate microbicidal activity
36、, and that this activity is both reliable and reproducible, such that the relationship for the inactivation of microorganisms can be extrapolated with reasonable confidence to low levels of probability of there being a viable microorganism present on a product after sterilization. This standard does
37、 not specify the maximal value to be taken by this probability; specification of this probability is given in EN 556-1. Requirements of the quality management system for medical device design/development, production, installation and servicing are given in EN ISO 13485. The standard for quality mana
38、gement systems recognizes that, for certain processes used in manufacturing or reprocessing, the effectiveness cannot be fully verified by subsequent inspection and testing of the product. Sterilization is an example of such a process. For this reason, sterilization processes are validated for use,
39、the performance of the sterilization process monitored routinely and the equipment maintained. Exposure to a properly validated, accurately controlled sterilization process is not the only factor associated with the provision of reliable assurance that the product is sterile and, in this regard, sui
40、table for its intended use. Attention is therefore given to a number of factors including: a) the microbiological status of incoming raw materials and/or components, b) the validation and routine control of any cleaning and disinfection procedures used on the product, c) the control of the environme
41、nt in which the product is manufactured, assembled and packaged, d) the control of equipment and processes, e) the control of personnel and their hygiene, f) the manner and materials in which the product is packaged, and, g) the conditions under which the product is transported and stored. Licensed
42、Copy: London South Bank University, London South Bank University, Mon May 07 12:20:30 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 15424:2007 (E) 6 The type of contamination on a product to be sterilized varies and this impacts upon the effectiveness of a sterilization process. Products that have b
43、een used in a health care setting and are being presented for re- sterilization in accordance with the manufacturers instructions (see EN ISO 17664) should be regarded as a special case. There is the potential for such products to possess a wide range of contaminating microorganisms and residual ino
44、rganic and/or organic contamination in spite of the application of a cleaning process. Hence, particular attention has to be given to the validation and control of the cleaning and disinfection processes used during reprocessing. The requirements are the normative parts of this standard with which c
45、ompliance is claimed. The guidance given in the informative annexes is not normative and is not provided as a checklist for auditors. The guidance provides explanations as well as methods that are accepted as being suitable means for complying with the requirements. Approaches other than those given
46、 in the guidance may be used, if they are effective in achieving compliance with the requirements of this European Standard. The development, validation and routine control of a sterilization process comprise a number of discrete but interrelated activities, for example calibration, maintenance, pro
47、duct definition, process definition, installation qualification, operational qualification, and performance qualification. While the activities required by this standard have been grouped together and are presented in a particular order, this European Standard does not require that the activities be
48、 performed in the order that they are presented. The activities required are not necessarily sequential, as the programs of development and validation may be iterative. It is possible that performing these different activities will involve a number of separate individuals and/or organizations, each
49、of whom undertake one or more of these activities. This European Standard does not specify the particular individuals or organizations to carry out the activities. Activities required by this standard might also give rise to an environmental burden that should be considered and minimized, e.g. by utilizing flexibility in planning. Environmental aspects are addressed in Annex D of this standard. Licensed Copy: London South Bank University, London South Bank University, Mon May 07 12:20:3