BS EN ISO 15223-1:2016
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied General requirements
Hardcopy , PDF
30-10-2021
English
31-03-2017
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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Withdrawn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 |
| 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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