BS EN ISO 15223-1:2016
Withdrawn
View Superseded by
Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied General requirements
Hardcopy , PDF
English
03-31-2017
10-30-2021
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
Gives requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices.
| Committee |
CH/210/3
|
| DevelopmentNote |
Supersedes 09/30176675 DC. Supersedes BS EN 980. (07/2012) Supersedes 15/30325469 DC. (12/2016)
|
| DocumentType |
Standard
|
| Pages |
44
|
| PublisherName |
British Standards Institution
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 15223-1:2016 | Identical |
| EN ISO 15223-1:2016 | Identical |
| I.S. EN ISO 15223-1:2016 | Equivalent |
| 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 |
| 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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