09/30176675 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN ISO 15223-1 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS
Hardcopy , PDF
English
31-07-2012
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Proposal of symbols for adoption
4.2 Requirements for usage
5 Symbols
5.1 Manufacture
5.2 Sterility
5.3 Storage
5.4 Safe Use
5.5 IVD-specific
5.6 Transfusion/infusion
5.7 Other
Annex A (informative) - Examples
Annex B (informative) - Use of general prohibition symbol
and negation symbol
Annex ZA (informative) - Clauses of this European Standard
addressing essential requirements or other
provisions of the Council Directive 93/42/EEC
concerning medical devices
Annex ZB (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 90/385/EEC on Active Implantable Medical
Devices
Annex ZC (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 98/79/EC on In vitro Diagnostic Medical
Devices
Bibliography
BS EN ISO 15223-1
| Committee |
CH/210/3
|
| DocumentType |
Draft
|
| Pages |
45
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| ISO 7010:2011 | Graphical symbols — Safety colours and safety signs — Registered safety signs |
| EN 591 : 2001 | INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE |
| EN 592 : 2002 | INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING |
| EN 376 : 2002 | INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| IEC TR 60878:2015 | Graphical symbols for electrical equipment in medical practice |
| ISO 8601:2004 | Data elements and interchange formats — Information interchange — Representation of dates and times |
| EN 375 : 2001 | INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE |
| 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 80416-2:2001 | Basic principles for graphical symbols for use on equipment — Part 2: Form and use of arrows |
| ISO 3864-1:2011 | Graphical symbols — Safety colours and safety signs — Part 1: Design principles for safety signs and safety markings |
| ISO 15225:2016 | Medical devices — Quality management — Medical device nomenclature data structure |
| ISO/TR 7239:1984 | Development and principles for application of public information symbols |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO 7000:2014 | Graphical symbols for use on equipment — Registered symbols |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
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