EN ISO 15223-1 2021 A1 2025

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EUROPEAN STANDARD

NORMEEUROPÉENNE

EUROPÄISCHE NORM

EN ISO15223-1:2021/A1

November 2025

ICS 11.040.01;01.080.20

English version

Medical devices -Symbols to be used with information to

be supplied by the manufacturer-Part 1:General

requirements -Amendment 1:Addition of defined term for

authorized representative and modified EC REP symbol to

not be country or region specific(ISO 152231:2021/Amd

1:2025)

Dispositifs médicaux-Symboles à utiliser avec les

informations à fournir par le fabricant-Partie 1:

Exigences générales-Amendement 1:Ajout du terme

défini représentant autorisé (mandataire)et

modification du symbole EC REP pour ne pas etre

spécifique d'un pays ou d'une région (ISO 15223

1:2021/Amd 1:2025)

Medizinprodukte -Symbole zur Verwendung im

Rahmen der vom Hersteller bereitzustellenden

Informationen-Teil 1:Allgemeine Anforderungen-

Änderung 1(ISO 152231:2021/Amd 1:2025)

This amendment A1modifies the European Standard EN ISO 15223-1:2021;it was approved by CEN on 16 September 2024.

CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for

inclusion of this amendment into the relevant national standard without any alteration.Up-to-date lists and bibliographical

references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to

anyCENandCENELEC member.

This amendment exists in three fficial versions (English,French,German).A version in any other language made by translation

under 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 committees ofAustria,Belgium,

Bulgaria,Croatia,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,Türkiye and United Kingdom.

EN ISO 15223-1:2021/A1:2025(E)

Contents Page

European foreword............................................................................................................................. 3

Annex ZA(informative) Relationship between this European standard and the General

Safety and Performance Requirements of Regulation(EU)2017/745 aimed to be

covered................................................................................................................................................... 4

Annex ZB(informative) Relationship between this European standard and the General

Safety and Performance Requirements of Regulation (EU)2017/746 aimed to be

covered ............................................................................................................................................... 18

EN ISO 15223-1:2021/A1:2025(E)

European foreword

This document (EN ISO 15223-1:2021/A1:2025)has been prepared by Technical Committee ISO/TC

210 "Quality management and corresponding general aspects for products with a health purpose

including medical devices"in collaboration with Technical Committee CEN-CENELEC/JTC 3“Quality

management and corresponding general aspects for medical devices”the secretariat of which is held by

NEN.

This Amendment to the European Standard EN ISO 15223-1:2021 shallbe given the status of a national

standard,either by publication of an identical text or by endorsement,at the latest by May 2026,and

conflicting national standards shall be withdrawn at the latest by May 2026.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights.CEN-CENELEC shall not be held responsible for identifying any or allsuch patent rights

This document has been prepared under a standardization request addressed to CEN and CENELEC by

the European Commission.The Standing Committee of the EFTA States subsequently approves these

requests for its Member States.

For the relationship with EU Legislation,see informative Annex ZA and ZB,which are an integral parts

of this document.

Any feedback and questions on this document should be directed to the users'national standards

body/national committee.A complete listing of these bodies can be found on the CEN and CENELEC

websites.

According to the CEN-CENELEC Internal Regulations,the national standards organizations of the

following countries are bound to implement this European Standard:Austria,Belgium,Bulgaria,

Croatia,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,Türkiye and the

United Kingdom.

Endorsement notice

The text of ISO 15223-1:2021/Amd 1:2025 has been approved by CEN-CENELEC as EN ISO 15223-

1:2021/A1:2025 without any modification.

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EUROPEANSTANDARDNORMEEUROPÉENNEEUROPÄISCHENORMENISO15223-1:2021/A1November2025ICS11.040.01;01.080.20EnglishversionMedicaldevices-Symbolstobeusedwithinformationtobesuppliedbythemanufacturer-Part1:Generalrequirements-Amendment1:AdditionofdefinedtermforauthorizedrepresentativeandmodifiedECREPsymboltono...

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