EESTI STANDARD EVS-EN 556-1:2002 Meditsiiniseadmete steriliseerimine. Nõuded meditsiiniseadmetele, mis on märgistatud sõnaga "STERIILNE". Osa 1: Nõuded lõplikult steriliseeritud meditsiiniseadmetele Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices. EESTI STANDARDIKESKUS
EESTI STANDARDI EESSÕNA NATIONAL FOREWORD Käesolev Eesti standard EVS-EN 556-1:2002 sisaldab Euroopa standardi EN 556-1:2001+AC:2006 ingliskeelset teksti. Käesolev dokument on jõustatud 19.04.2002 ja selle kohta on avaldatud teade Eesti standardiorganisatsiooni ametlikus väljaandes. Standard on kättesaadav Eesti standardiorganisatsioonist. This Estonian standard EVS-EN 556-1:2002 consists of the English text of the European standard EN 556-1:2001+AC:2006. This document is endorsed on 19.04.2002 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 European Standard specifies the requirements for a terminally-sterilized medical device to be designated 'STERILE': Part 2 of this European Standard specifies the requirements for an aseptically processed medical device to be designated "STERILE". Scope: This European Standard specifies the requirements for a terminally-sterilized medical device to be designated 'STERILE': Part 2 of this European Standard specifies the requirements for an aseptically processed medical device to be designated "STERILE". ICS 11.080.01 Võtmesõnad: medical equipm, medical instruments, medical products, medical sciences, medicine, packages, packing, quality assurance, safety, specification (approval), specifications, steam, sterile, sterile equipment, sterilization, sterilization (hygiene), sterility, vapours Eesti Standardikeskusele kuulub standardite reprodutseerimis- ja levitamisõigus
EN 556-1 ICS 11.080.01 Descriptors: October 2001 Supersedes EN 556 : 1994. English version Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 1: Requirements for terminally sterilized medical devices Stérilisation des dispositifs médicaux Exigences relatives aux dispositifs médicaux en vue d obtenir l étiquetage STERILE Partie 1: Exigences relatives aux dispositifs médicaux stérilisés au stade terminal Sterilisation von Medizinprodukten Anforderungen an Medizinprodukte, die als STERIL gekennzeichnet werden Teil 1: Anforderungen an Medizinprodukte, die in der Endpackung sterilisiert wurden This European Standard was approved by CEN on 2001-08-18. 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, the Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, 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 6, B-1050 Brussels 2001. CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national members. Ref. No. EN 556-1 : 2001 E
Page 2 EN 556-1 : 2001 2 5 5 6
Page EN 556-1 : 2001