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02/563809 DC : DRAFT SEP 2002

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BS EN 980 - GRAPHICAL SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES

Superseded date

08-13-2003

Published date

11-23-2012

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 TESTS"
   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
         TESTS"
   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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