EN ISO 15223-1:2016/FprA11

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, including corrected version 2017-03)

20200402JO- link to MDD,IVD, AIMD and M/023,M/252,M/295 removed. These links are included in the previous published version  EN ISO 15223-1:2016 - JT003045

Medizinprodukte - Bei Aufschriften von Medizinprodukten zu verwendende Symbole, Kennzeichnung und zu liefernde Informationen - Teil 1: Allgemeine Anforderungen (ISO 15223-1:2016, einschließlich korrigierte Fassung 2017-03)

Dispositifs médicaux - Symboles à utiliser avec les étiquettes, l'étiquetage et les informations à fournir relatifs aux dispositifs médicaux - Partie 1: Exigences générales (ISO 15223-1:2016, y compris la version corrigée de mars 2017)

Medicinski pripomočki - Simboli za označevanje medicinskih pripomočkov, označevanje in podatki, ki jih mora podati dobavitelj - 1. del: Splošne zahteve (ISO 15223-1:2016)

General Information

• Status: Not Published
• Publication Date: 17-May-2021
• Withdrawal Date: 17-Nov-2021
• ICS: 01.080.20 - Graphical symbols for use on specific equipment
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Drafting Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Current Stage: 5098 - Decision to abandon - Formal Approval
• Completion Date: 23-Feb-2022
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/565 - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
• Mandate: M/MDR - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
• Ref Project: SIST EN ISO 15223-1:2017/oprA1:2019 - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016)

Relations

• Amends: EN ISO 15223-1:2016 - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15223-1:2017/oprA1:2019
01-december-2019
Medicinski pripomočki - Simboli za označevanje medicinskih pripomočkov,
označevanje in podatki, ki jih mora podati dobavitelj - 1. del: Splošne zahteve (ISO
15223-1:2016)
Medical devices - Symbols to be used with medical device labels, labelling and
information to be supplied - Part 1: General requirements (ISO 15223-1:2016)
Medizinprodukte - Bei Aufschriften von Medizinprodukten zu verwendende Symbole,
Kennzeichnung und zu liefernde Informationen - Teil 1: Allgemeine Anforderungen (ISO
15223-1:2016)
Dispositifs médicaux - Symboles à utiliser avec les étiquettes, l'étiquetage et les
informations à fournir relatifs aux dispositifs médicaux - Partie 1: Exigences générales
(ISO 15223-1:2016)
Ta slovenski standard je istoveten z: EN ISO 15223-1:2016/prA1
ICS:
01.080.20 Grafični simboli za posebno Graphical symbols for use on
opremo specific equipment
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN ISO 15223-1:2017/oprA1:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 15223-1:2017/oprA1:2019

---------------------- Page: 2 ----------------------
SIST EN ISO 15223-1:2017/oprA1:2019


EUROPEAN STANDARD
DRAFT
EN ISO 15223-1:2016
NORME EUROPÉENNE

EUROPÄISCHE NORM
prA1
October 2019
ICS 01.080.20; 11.040.01

English version

Medical devices - Symbols to be used with medical device
labels, labelling and information to be supplied - Part 1:
General requirements (ISO 15223-1:2016)
Dispositifs médicaux - Symboles à utiliser avec les Medizinprodukte - Bei Aufschriften von
étiquettes, l'étiquetage et les informations à fournir Medizinprodukten zu verwendende Symbole,
relatifs aux dispositifs médicaux - Partie 1: Exigences Kennzeichnung und zu liefernde Informationen - Teil
générales (ISO 15223-1:2016) 1: Allgemeine Anforderungen (ISO 15223-1:2016)
This draft amendment is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/CLC/JTC 3.

This draft amendment A1, if approved, will modify the European Standard EN ISO 15223-1:2016. If this draft becomes an
amendment, 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.

This draft amendment was established by CEN and CENELEC in three official 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 of 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, Turkey and United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.Recipients of this draft are invited to submit, with their comments, notification
of any relevant patent rights of which they are aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.

---------------------- Page: 3 ----------------------
SIST EN ISO 15223-1:2017/oprA1:2019
EN ISO 15223-1:2016/prA1:2019 (E)
Contents Page
European foreword . 3
Annex ZD (informative) Relationship between this European standard and the
requirements of Regulation (EU) 2017/745 aimed to be covered . 4
Annex ZE (informative) Relationship between this European standard and the
requirements of Regulation (EU) 2017/746 aimed to be covered . 9
2

---------------------- Page: 4 ----------------------
SIST EN ISO 15223-1:2017/oprA1:2019
EN ISO 15223-1:2016/prA1:2019 (E)
European foreword
The text of ISO 15223-1:2016 has been prepared by Technical Committee ISO/TC 210 “Quality
management and corresponding general aspects for medical devices” of the International Organization
for Standardization (ISO) and has been taken over as EN ISO 15223-1:2016/prA1:2019 by Technical
Committ
...