I.S. EN ISO 15223-1:2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
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)
Hardcopy , PDF
English
01-01-2016
11-07-2020
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.
Dates of withdrawal of national standards are available from NSAI.
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Superseded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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