02/563809 DC : DRAFT SEP 2002
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
BS EN 980 - GRAPHICAL SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES
13-08-2003
23-11-2012
Introduction
1 Scope
2 Normative references
3 General requirements
4 Symbols already in use
4.1 General
4.2 Symbol for "DO NOT REUSE"
4.3 Symbol for "USE BY"
4.4 Symbol for "BATCH CODE"
4.5 Symbol for "SERIAL NUMBER"
4.6 Symbol for "DATE OF MANUFACTURER"
4.7 Symbol for "STERILE"
4.8 Symbols for "STERILE",including the "METHODS OF
STERILIZATION"
5 New symbols
5.1 General
5.2 Symbol for "MANUFACTURER"
5.3 Symbol for "AUTHORISED REPRESENTATIVE IN THE EUROPEAN
COMMUNITY"
5.4 Symbol for "CONTAINS SUFFICIENT FOR
5.5 Symbol for "FOR IVD PERFORMANCE EVALUATION ONLY"
5.6 Symbol for "IN VITRO DIAGNOSTIC MEDICAL DEVICE"
5.7 Symbols for temperature limits
5.8 Symbol for "CONSULT INSTRUCTIONS FOR USE"
5.9 Symbol for "BIOLOGICAL RISKS"
Annex A (informative) Examples of uses of symbols given in this
standard
A.1 Example of use of symbol for "USE BY"
A.2 Example of use of symbol for "BATCH CODE"
A.3 Examples of use of symbol for "SERIAL NUMBER"
A.4 Examples of use of symbol for "DATE OF MANUFACTURE"
A.5 Examples of use of symbol for "CATALOGUE NUMBER"
A.6 Examples of use of symbol for "MANUFACTURER"
A.7 Examples of use of symbol for "AUTHORISED REPRESENTATIVES IN
THE EUROPEAN COMMUNITY"
A.8 Examples of use of symbol for "CONTAINS SUFFICIENT FOR
A.10 Example of use of symbol for "LOWER LIMIT OF TEMPERATURE"
A.11 Example of use of symbol for "TEMPERATURE LIMITATION"
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) Clauses of this European Standard addressing
essential requirements or other provisions of the Council
Directive 90/385/EEC relating to active implantable medical
devices
Annex ZC (informative) Clauses of this European addressing essential
requirements or other provisions of the European Parliament
and the Council Directive 98/79/EC on in vitro diagnostic
medical devices
Bibliography
BS EN 980
| Committee |
CH/210/3
|
| DocumentType |
Draft
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| PREN 980 : DRAFT 2002 | Identical |
| IEC 60416:1988 | General principles for the formulation of graphical symbols |
| IEC 60417-1:2002 | Graphical symbols for use on equipment - Part 1: Overview and application |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| EN 60417-1:2002 | GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - PART 1: OVERVIEW AND APPLICATION |
| EN 376 : 2002 | INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING |
| EN 60417-2:1999 | Graphical symbols for use on equipment - Part 2: Symbol originals |
| 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 60417-2:1998 | Graphical symbols for use on equipment - Part 2: Symbol originals |
| EN 61010-1:2010 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
| ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| EN 28601 : 1992 | DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES |
| IEC 61010-1:2010+AMD1:2016 CSV | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
| ISO 15223:2000 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied |
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