BS-EN-13060-2004.pdf
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1、BRITISH STANDARD BS EN 13060:2004 Incorporating Corrigendum No. 1 Small steam sterilizers The European Standard EN 13060:2004 has the status of a British Standard ICS 11.080.10 ? BS EN 13060:2004 This British Standard was published under the authority of the Standards Policy and Strategy Committee o
2、n 3 August 2005 BSI 14 March 2006 ISBN 0 580 46187 4 National foreword This British Standard is the official English language version of EN 13060:2004. It supersedes BS 3970-4:1990 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee LBI/35, Sterilizers, a
3、utoclaves and disinfectors, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European
4、developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. NOTE The United Kingdom was not in favour of publication of this standard and had various comments on the draft. A user guide is under consideration by the B
5、ritish committee for publication as a supplement to this BS EN giving guidance as to its application under United Kingdom conditions. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the
6、 section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct applicati
7、on. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 66, an inside back cover and a back cover. The BSI copyright notice displayed in this documen
8、t indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments 16207? Corrigendum No. 1 March 2006See revised national foreword EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13060 June 2004 ICS 11.080.10 English version Small steam sterilizers Petits
9、strilisateurs la vapeur deauDampf-Klein-Sterilisatoren This European Standard was approved by CEN on 16 April 2004. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any
10、 alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application 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
11、translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Gree
12、ce, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre
13、: rue de Stassart, 36 B-1050 Brussels 2004 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13060:2004: E Incorporating Corrigendum January 2006 EN 13060:2004 (E) 2 Contents page Foreword3 Introduction.4 1Scope 5 2Normative reference
14、s5 3Terms and definitions .6 4General technical requirements.13 5Performance requirements.29 6Safety 30 7Categories of tests.30 8Test equipment 32 9Test programme.40 10Test methods41 Annex A (informative) Clarification of the definition of hollow space A and hollow space B (see 3.19 and 3.20) .57 An
15、nex B (informative) Process evaluation system.59 Annex C (informative) Suggested maximum limits of contaminants in and specification for water for steam sterilization60 Annex D (informative) Example of a table to be supplied with pre-purchase documentation and with the instructions for use.61 Annex
16、E (informative) Load support systems.62 Annex F (informative) Rationale for the tests63 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42 EEC on medical devices .65 Bibliography66 EN 13060:2004 (E) 3 Foreword This document (EN 130
17、60:2004) has been prepared by Technical Committee CEN/TC 102 “Sterilizers for medical purposes”, the secretariat of which is held by DIN. 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 December 2
18、004, and conflicting national standards shall be withdrawn at the latest by December 2004. 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
19、 Directive(s), see informative annex ZA which is an integral part of this document. The annexes A, B, C, D, E and F are informative. This document includes a Bibliography. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to
20、implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kin
21、gdom. EN 13060:2004 (E) 4 Introduction Small steam sterilizers are widely used for medical purposes, e.g. in general medical practices, dentistry, facilities for personal hygiene and beauty care and also veterinary practices. They are also used for materials and equipment, which are likely to come i
22、nto contact with blood or body fluids, e.g. implements used by beauty therapists, tattooists, body piercers and hairdressers. The very specific sterilizer loads used within these fields of application call for different performance requirements for the sterilization cycles and different correspondin
23、g test methods. This European Standard specifies the general requirements for small steam sterilizers and test methods for specified sterilizer loads according to Table 1. These loads include unwrapped solid products, full porous load, small porous load, small porous items, hollow loads A, hollow lo
24、ads B, single wrapped products and double wrapped products. The performance tests specified in this standard can also be used by device manufacturers to specify the appropriate performance for decontamination processes according to the requirements for information to be given by medical device manuf
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