MEDITSIINISEADMED. NOUDED KVALITEEDIJUHTIMISSUSTEEMID.NORMATIIVSED
Medicaldevices-Qualitymanagementsystems-Requirementsforregulatorypurposes(Iso13485:2016)
EESTISTANDARDIEESSONA
NATIONALFOREWORD
Eesti standard EVS-EN This Estonian standard EVS-EN13485:2016/A11:2021 See sisaldab Euroopa ISO 13485:2016/A11:2021 consists of the English text ISOstandardi EN ISO 13485:2016/A11:2021 of 13485:2016/A11:2021. the European standard EN ISOingliskeelset teksti.avaldamisega EVS Teatajas. Standard on joustunud sellekohase teate This notification published in the official bulletin of the standard hasbeenendorsedwithEstonian Centre Standardisation pueEuroopa standardimisorganisatsioonid on teinud Accreditation.Euroopa kattesaadavaks 08.09.2021. standardi rahvuslikele likmetele Date of Availability of the European standard ISO8.09.2021.Akrediteerimiskeskusest. for Standardisation and Accreditation.
Tagasisidet standardi sisu kohta on voimalik edastada kasutades EVS-i veebilehel asuvat tagasiside vormivoi saates e-kirja meiliaadressile standardiosakond@evs.ee.
ICS 03.100.70 11.040.01
Standardite reprodutseerimise ja levitamise oigus kuulub Eesti Standardimis- ja AkrediteerimiskeskuseleAndmete paljundamine taastekitamine kopeerimine salvestamine elektroonsesse sisteemi voi edastamine ikskik millises vormis voimillisel tee ilma Eesti Standardimis- ja Akrediteerimiskeskuse kirjliku loata on keelatud.Keduleht telefon 605 5050: e-pst infofev.ce Kui Teil on kusimusi standardite autorioiguse kaitse kohta votke palun ihendust Eesti Standardimis- ja Akrediteerimiskeskusega:The right to reproduce and distribute standards belongs to the Estonian Centre for Standardisation and AccreditationNo part of this pblication my be reproduced or utilized in any fom or by any means electronic or mechanical including photocopying without a written permision from the Estonian Centre for Standardisation and Accreditation.If you have any questions about standards copyright protection please contact the Estonian Cente for Standardisation and Accreditation:Homepage phone 372 605 5050; e-mail info0levs.ee
English version
Dispositifs medicaux - Systemes de management de laqualite - Exigences a des fins reglementaires (ISO 13485:2016)
Medizinprodukte - Qualititsmanagementsysteme -Anforderungen fur regulatorische Zwecke (ISO 13485:2016)
This amendment A11 modifies the European Standard EN ISO 13485:2016; it was approved by CEN on 12 April 2021.
CEN and CENELEC members are bound to ply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment into the relevant national standard without any alteration Up-todate lists and bibliographicalreferences concerning such national standards may he obtained on application to the CEN-CENELEC Management Centre or to any CEN and CENELEC member.
This amendment exists in three official versions (English French German). A version in any other language made by translationunder the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical mittees of Austria Belgium Bulgaria Croatia Cyprus Czech Republi Denmark Estonia Finland France Gemany 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 United Kingdom.
Contents
Europeanforeword..Annex ZA (informative) Relationship between this European standard and therequirements of Regulation (EU) 2017/745 aimed to be covered 4requirements of Regulation (EU) 2017/746 aimed to be covered. 16
Annex ZB (informative) Relationship between this European standard and the
Europeanforeword
This document (EN ISO 13485:2016/A11:2021) has been prepared by Technical CommitteeCEN/CLC/TC 3 “Quality management and corresponding general aspects for medical devices" thesecretariat of which is held by NEN.
This document amends EN ISO 13485:2016 incorporating corrigenda March 2016 December 2016 and 2018 with a revised European Foreword and European Annexes ZA and ZB.
This Amendment to the European Standard EN ISO 13485:2016 has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association and supportsrequirements of EU Regulation(s).
For relationship with EU Regulation(s) see informative Annex ZA and ZB which are an integral part ofthis document.
Any feedback and questions on this document should be directed to the users' national standardsbody/national mittee. A plete listing of these bodies can be found on the CEN websites.
The following referenced documents are indispensable for the application of this document.For undateddated references only the edition cited applies.However forany use ofthis standard within the meaning references the edition of the referenced document (including any amendments) listed below applies. Forof Annex ZA or ZB the user should always check that any referenced document has not been supersededand that its relevant contents can still be considered the generally acknowledged state-of-art.
normative reference to the corresponding EN standard if available and otherwise to the dated version When an IEC or ISO standard is referred to in the ISO standard text this should be understood as aof the ISO or IEC standard as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines theextent (in whole or in part) to which they apply.
Table - Correlation between normative references and dated EN and ISO standards
Normative references Equivalent dated standardas listed in Clause 2 of the ISO EN ISOstandardISO 9000:2015 EN ISO 9000:2015 ISO 9000:2015
According to the CEN-CENELEC Internal Regulations the national standards organizations of thefollowing countries are bound to implement this European Standard: Austria Belgium Bulgaria Croatia Italy Latvia Lithuania Luxembourg Malta Netherlands Norway Poland Portugal Republic of NorthMacedonia Romania Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey and the United Kingdom.
