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I.S. EN ISO 15223-1:2016

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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)
Available format(s)

Hardcopy , PDF

Superseded date

11-07-2020

Language(s)

English

Published date

01-01-2016

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Symbols
Annex A (informative) - Examples
Annex B (informative) - Use of general prohibition
        symbol and negation symbol
Bibliography
Annex ZA (informative) - Relationship between this
        European Standard and the Essential Requirements
        of EU Directive 93/42/EEC [OJ L 169] on Medical Devices
Annex ZB (informative) - Relationship between this
        European standard and the essential requirements
        of Directive 90/385/EEC [OJ L 189] aimed to be covered
Annex ZC (informative) - Relationship between this
        European standard and the essential requirements of
        Directive 98/79/EC [OJ L 331] aimed to be covered

Defines requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices.

Committee
TC 210
DevelopmentNote
Supersedes I.S. EN 980. (07/2012) 2016 Edition Incorporates Corrigendum. (01/2017)
DocumentType
Standard
Pages
50
ProductNote
CORRECTED VERSION IS NOW AVAILABLE FOR THIS STANDARD The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 15223-1:2016 Identical
EN ISO 15223-1:2016 Identical

ISO 7010:2011 Graphical symbols Safety colours and safety signs Registered safety signs
ISO 15223-2:2010 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
ISO 18113-4:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
IEC 80416-3:2002+AMD1:2011 CSV Basic principles for graphical symbols for use on equipment - Part 3: Guidelines for the application of graphical symbols
IEC 80416-1:2008 Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
ISO 18113-2:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
ISO 3864-1:2011 Graphical symbols Safety colours and safety signs Part 1: Design principles for safety signs and safety markings
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
ISO 18113-5:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
ISO 18113-3:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use

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$143.56
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