BS-EN-ISO-14937-2001.pdf
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1、BRITISH STANDARD BS EN ISO 14937:2001 Incorporating corrigenda nos. 1, 2 and 3 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices The European Standa
2、rd EN ISO 14937:2000 has the status of a British Standard ICS 11.080.01 ? BS EN ISO 14937:2001 This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 Marc
3、h 2001 BSI 2007 ISBN 0 580 37085 2 National foreword This British Standard was published by BSI. It is the UK implementation of EN ISO 14937:2000, incorporating corrigenda December 2003 and March 2005. It is identical with ISO 14937:2000, incorporating Technical Corrigendum June 2003. The UK partici
4、pation in its preparation was entrusted to Technical Committee CH/67, Sterilization of medical devices. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users ar
5、e responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments issued since publication Amd. No. DateComments 13353 Corrigendum No. 1 September 2001 Insertion of Annex ZB and Annex ZC 15195 Corrigendum No. 2 16 June 2004Change
6、to D.2.5 and deletion of Annex ZA 17059 Corrigendum No. 3 30 April 2007Annex ZC renumbered as Annex ZA EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14937 December 2000 ICS 11.080.01 Incorporating corrigenda December 2003 and March 2005 English version Sterilization of health care product
7、s - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000) Strilisation des produits de sant - Exigences gnrales pour la caractrisation dun agent strilisant et pour le dvelop
8、pement, la validation et la vrification de routine dun processus de strilisation pour dispositifs mdicaux (ISO 14937:2000) Sterilisation von Produkten fr die Gesundheitsfrsorge - Allgemeine Anforderungen an die Charakterisierung eines Sterilisiermittels und an die Entwicklung, Validierung und Routin
9、eberwachung eines Sterilisationsverfahrens fr Medizinprodukte (ISO 14937:2000) This European Standard was approved by CEN on 15 December 2000. 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 na
10、tional standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in an
11、y other language made by translation under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany
12、, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, 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 2000 CENAll rights
13、of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14937:2000 E gaPe 2 I NESO 4173902:00 Foreword Corrected 2001-02-14 The text of the International Standard ISO 14937:2000 has been prepared by Technical Committee ISO/TC 198 “Sterilization of he
14、alth care products“ in collaboration with 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 b
15、y June 2001, and conflicting national standards shall be withdrawn at the latest by June 2001. This European Standard 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 relatio
16、nship with EU Directive(s), see informative Annex ZB, which is an integral part of this standard. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmar
17、k, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO 14937:2000 was approved by CEN as a European Standard without any modification. NO
18、TE: Normative references to International Standards are listed in annex ZA (normative). EN ISO 14937:2000 I NESO 13:6402/00AC:20( 30EF/)D/ 2 v hsilgnEenoisr Endorsement notice The text of ISO 3146:2000/Cor.1:2002 has been approved by CEN as a European without any modifications. f noisreVrianaes cito
19、Ne edntrienemtn xet eLted e IlSO 13:640002roC/.102:20 t aa rppuov rap le CEc NommroC erinegmud ruepos neasn cuaum enfidoicaoitn. DetuaF ehcsgnuss Anerkesgnunnziton reD Text I novSO 3:64102C/00or.2:1200 wurdv eom sla NEC ruEopsicseh Corriegmudn enho rigdneniee bArednnuneg gmhe.tgi Page 2 EN ISO 14937
20、:2000 weroFdro oCerrtcde 2-1000-241 Txet eht fo nI ehtretantoianS ltnaradI dSO 139402:7h 00sa bnee rpperade by TcecinhC lamomeetti OSI/TC 891 tS“eriiltazion fo aehhtl care rpocudst“ c niollrobaatoin T htiweccinhamoC lmT/NEC eettiC 402 tS“eriliztanoi fo mcideaed lcives“ht ,s eecrratetai fo whcih si e
21、hb dly SB.I Tsih ruEepona atSradnd slahb lg einev s ehttsuta fo n aitaanos ltaradnd, eireht by uplbciitano fo na edicitnaxet lt ro by erodnsmet ta ,tneeh talset by Jnu02 e,10 dna cfnocilnitg tannois latdnarasd slahb le htiwrdawn t taeh setalt by Juen 002.1 Tsih ruEepona atSradnd sah beerp nperade dn
22、ure m atadnag eivt neC oEb Ny tE ehruponae moCmssiina noht dE eruepoF nareT ersA edascoiita,no s dnaupprost sesitner laeuqrimestne fo UE Diertcvie(.)s For retalionshpi with EU Directiv(es)s ,ee fniormnA evitaxen ZB, cihwh si na tnirgela part fo siht staradnd. cAcronidot g eht NEC/ENECLEC retnInla ge
23、Rluitasnoht ,n eitaanos ltaradnsd ronagiztasnoi fo hte folloc gniwortnuise rae nuobt dmi omelpht tnesi ruEoaepn natSrad:d suAtri,a eBglmui, cezCeR huplbci, mneDrak, FinalnF ,drcnae, Gremnay, Grcee,e cIalerI ,dnle,dna atIly, xuLmeruobN ,ghterealsdnN ,roway, roPtulagS ,api,n SwenediwS ,trezldna naht d
24、nU eetiiK dnmodg. Erodnseemciton tne Txet eht fo nI ehtretantoianS ltnaradI dSO 139402:7aw 00s parpovde by ECsa N E aruoaepn natSradd htiwtuo nay mfidoicnoita. ONTEroN :mr evitaferecnese I otretnnitaanol atSradnsd ral eistde ni naxen ZC (ronmvita)e. 0002:73941 OSI NE EN ISO 3146:2000/AC:0203 (E/F/D)
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