Titlu Sterilizarea produselordeingrijirea sanatatiMetodemicrobiologice Partea1:Determinarea uneipopulati demicroorganismepeproduseAmendament1Sterilzation of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1Sterilisation des produits de sante - AMethodes microbioiogiques - Partie 1:Determination dune population de microorganismes sur des produits - Amendement 1Aprobare Aprobat de Directorul General al ASRO la 31 august 2021EN ISO 11737-1:2018 are statutul unui standard roman Acest amendament impreuna cu standardul europeanData publicari versiunii romane: -CorespondentaAcest amendament este identic cu amendamentul EN ISO 11737-1:2018/A1:2021
Ref.: SR EN ISO 11737-1:2018/A1:2021
Pentru un singur utilizator. Copierea si distribuirea sunt strict interzise.
English Version
Sterilizationofhealthcareproducts-Microbiological methods-Part1:Determinationofapopulationof 1:2018/Amd 1:2021)
microbiologiques - Partie 1: Determination d’une Sterilisation des produits de sante - Methodespopulation de microorganismes sur des produits - Amendement 1 (ISO 11737-1:2018/Amd 1:2021)
Gesundheitsfirsorge - Mikrobiologische Verfahren - Sterilisation von Produkten fur dieMikroorganismen auf Produkten - Anderung 1 (ISO Teil 1: Bestimmung der Population von11737-1:2018/Amd 1:2021)
This amendment A1 modifes the European Standard EN ISO 11737-1:2018;it was approved by CEN on 28 September 2020.
CEN members are bound to ply with the CEN/CENELEC Intermal Regulations which stipulate the conditions for inclusion ofthis amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationa standards may be obtained on aplication to the CEN-CENELEC Management Centre or to any CENmember.
This amendment exists 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 CEN-CENELEC Management Centre has thesame status as the official versions.
Finland France Germany Greece Hungary lland Ireland taly Latvia Lithuania Luxembourg Malta Netherlands Norway CEN members are the national standards bodies of Austria Belgium Bulgaria Croatia Cyprus Czech Republic Denmark Estonia United Kingdom. Poland Portugal Republic of North Macedonia Romania Serbia Slovalkia Slovenia Spain Sweden Switzerland Turkey and
EUROPEAN COMMITEE FOR STANDARDIZATIONEUROPAISCHES KOMITEE FOR NORMUNG COMITE EUROPEEN DE NORMALISATION
CEN-CENELEC Management Centre: Rue de la Science 23 B-1040 Brussels
Contents
European foreword.Annex ZA (informative) Relationship between this European standard and the GeneralSafety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered.... 5Annex ZB (informative) Relationship between this European standard and the Generalcovered..
Europeanforeword
This document (EN ISO 11737-1:2018/A1:2021) has been prepared by Technical Committee ISO/TC‘Sterilization of medical devices" the secretariat of which is held by BSI.
This Amendment to the European Standard EN ISO 11737-1:2018 shall be given the status of a national standard either by publication of an identical text or by endorsement at the latest by December 2021 and conflicting national standards shall be withdrawn at the latest by December 2021.
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
pe ss a q eanads sEuropean Free Trade Association and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s) and Regulations see informative Annex ZA and ZB which are anintegral part of this document.
undated references the edition of the referenced document (including any amendments) listed belowapplies. For dated references only the edition cited applies. However for any use of this standardwithin the meaning of Annex ZA or ZB the user should always check that any referenced document has paae eaa paapisuo aq ts u saoo ueaaa sh e pe papasadns uaaq roustate-of-art.
When an IEC or ISO standard is referred to in the ISO standard text this should be understood as asa pp a o sao pe ae ps a a aa aoof the ISO or IEC standard as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply.
Table - Correlation between normative references and dated EN and ISO standards
as listed in Clause 2 of the ISO Normative references Equivalent dated standardstandard EN ISOISO 10012 EN ISO 10012:2003 ISO 10012:2003ISO 13485 EN ISO 13485:2016 ISO 13485:2016ISO 15189 EN ISO 15189:2012 ISO 15189:2012ISO/IEC 17025 EN ISO/IEC 17025:2017 ISO/IEC 17025:2017
NOTE The standards normatively referred to by ISO 11737-1:2018/Amd 1:2021 are undated. These referredreferences it should always be assumed that the latest edition applies. standards also include normative references to other dated and undated standards. For undated normative
following countries are bound to implement this European Standard: Austria Belgium Bulgaria According to the CEN-CENELEC Internal Regulations the national standards organizations of theCroatia Cyprus Czech Republic Denmark Estonia Finland France Germany Greece Hungary Iceland Ireland Italy Latvia Lithuania Luxembourg Malta Netherlands Norway Poland Portugal Republic of North Macedonia Romania Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey and theUnited Kingdom.
Endorsementnotice
The text of ISO 11737-1:2018/Amd1:2021 has been approved by CEN as EN ISO 11737-1:2018/A1:2021 without any modification.
