DIN EN 556-1-2002 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 1 Requirements for terminally sterilized medical devices Germa.pdf

1、ICS 11.080.01Sterilisation von Medizinprodukten Anforderungenan Medizinprodukte, die als STERIL“ gekennzeichnetwerden Teil 1: Anforderungen an Medizinprodukte,die in der Endpackung sterilisiert wurdenEuropean Standard EN 556-1 : 2001 has the status of a DIN Standard.National forewordThis standard ha

2、s been prepared by CEN/TC 204 Sterilization of medical devices (Secretariat: UnitedKingdom).The responsible German body involved in its preparation was the Normenausschuss Medizin (MedicalStandards Committee), Technical Committee Sterilisation von Medizinprodukten.AmendmentsThis standard differs fro

3、m the January 2001 edition in that a printing error has been corrected.Previous editionsDIN EN 556: 1995-01; DIN EN 556-1: 1999-01, 2001-01.Ref. No. DIN EN 556-1 : 2002-03English price group 08 Sales No. 110805.02DEUTSCHE NORM March 2002EN 556-1Continued overleaf.EN comprises 6 pages. No part of thi

4、s standard may be reproduced without the prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).Sterilization of medical devices Requirements formedical devices to be designated ST

5、ERILEPart 1: Requirements for terminally sterilized medical devicesEnglish version of DIN EN 556-1Supersedes DIN EN 556-1,January 2001 edition.English versionICS 11.080.01Descriptors:Sterilization of medical devices Requirements formedical devices to be designated STERILEPart 1: Requirements for ter

6、minally sterilized medical devices 2001. CEN All rights of exploitation in any form and by any meansreserved worldwide for CEN national members.Ref. No. EN 556-1 : 2001 ESterilisation von Medizinprodukten Anforderungen an Medizinprodukte,die als STERIL“ gekennzeichnetwerden Teil 1: Anforderungen anM

7、edizinprodukte, die in derEndpackung sterilisiert wurdenThis European Standard was approved by CEN on 2001-08-18.CEN members are bound to comply with the CEN/CENELEC Internal Regulationswhich stipulate the conditions for giving this European Standard the status of anational standard without any alte

8、ration.Up-to-date lists and bibliographical references concerning such national stand-ards may be obtained on application to the Management Centre or to anyCEN member.The European Standards exist in three official versions (English, French, German).A version in any other language made by translation

9、 under the responsibility of aCEN member into its own language and notified to the Management Centre hasthe same status as the official versions.CEN members are the national standards bodies of Austria, Belgium, the CzechRepublic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy,Lu

10、xembourg, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland,and the United Kingdom.EN 556-1October 2001Management Centre: rue de Stassart 36, B-1050 BrusselsEuropean Committee for StandardizationComit Europen de NormalisationEuropisches Komitee fr Normung|Strilisation des dispositifsmdicaux Exigences relatives auxdispositifs mdicaux en vue dobtenirltiquetage STERILE Partie 1:Exigences relatives aux dispositifsmdicaux striliss au stade terminalSupersedes EN 556 : 1994.Page 2EN 556-1 : 200123333556Page 3EN 556-1 : 2001Page 4EN 556-1 : 2001Page 5EN 556-1 : 2001Page 6EN 556-1 : 2001