EESTI STANDARD EVS-EN ISO 174:2004 Meditsiiniseadmete steriliseerimine. Tootja poolt esitatav informatsioon resteriliseeritavate meditsiiniseadmete käitlemise kohta Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices EESTI STANDARDIKESKUS
EESTI STANDARDI EESSÕNA NATIONAL FOREWORD Käesolev Eesti standard EVS-EN ISO 174:2004 sisaldab Euroopa standardi EN ISO 174:2004 ingliskeelset teksti. Käesolev dokument on jõustatud 18.0.2004 ja selle kohta on avaldatud teade Eesti standardiorganisatsiooni ametlikus väljaandes. Standard on kättesaadav Eesti standardiorganisatsioonist. This Estonian standard EVS-EN ISO 174:2004 consists of the English text of the European standard EN ISO 174:2004. This document is endorsed on 18.0.2004 with the notification being published in the official publication of the Estonian national standardisation organisation. The standard is available from Estonian standardisation organisation. Käsitlusala: This standard specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be resterilizable and medical devices intended to be sterilized by the processor. Scope: This standard specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be resterilizable and medical devices intended to be sterilized by the processor. ICS 11.080.01 Võtmesõnad: Standardite reprodutseerimis- ja levitamisõigus kuulub Eesti Standardikeskusele
EN ISO 174 ICS 11.080.01 March 2004 English version Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 174 : 2004) Stérilisation des dispositifs médicaux Informations devant être fournies par le fabricant pour le processus de restérilisation des dispositifs médicaux (ISO 174 : 2004) Sterilisation von Medizinprodukten Vom Hersteller bereitzustellende Informationen für die Aufbereitung von resterilisierbaren Medizinprodukten (ISO 174 : 2004) This European Standard was approved by CEN on 2003-11-03. 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 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. The European Standards exist 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 Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, and the United Kingdom. ÈÉË European Committee for Standardization Comité Européen de Normalisation Europäisches Komitee für Normung Management Centre: rue de Stassart 3, B-1050 Brussels 2004. CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national members. Ref. No. EN ISO 174 : 2004 E
Page 2 EN ISO 174 : 2004 3 3 4 4 7 7 7 8 8 10 10 11 11 12 1 21
Page 3 EN ISO 174 : 2004
Page 4 EN ISO 174 : 2004