PREN 980 : DRAFT 2002

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

Defines graphical symbols for use in the information supplied by the manufacturer with medical devices.