Foreword
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 MANUFACTURE"
4.7 Symbol for "STERILE"
4.8 Symbols for "STERILE", including the "METHOD OF
STERILIZATION"
4.8.1 Symbol for method of sterilization using
ethylene oxide
4.8.2 Symbol for method of sterilization using
irradiation
4.8.3 Symbol for method of sterilization using
steam or dry heat
4.9 Symbol for "CATALOGUE NUMBER"
4.10 Symbol for "CAUTION, CONSULT ACCOMPANYING
DOCUMENTS"
4.11 Symbol for sterile medical devices processed
using aseptic technique
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
5.7.1 Symbol for "UPPER LIMIT OF TEMPERATURE"
5.7.2 Symbol for "LOWER LIMIT OF TEMPERATURE"
5.7.3 Symbol for "TEMPERATURE LIMITATION"
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 Examples 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
REPRESENTATIVE IN THE EUROPEAN COMMUNITY"
A.8 Examples of use of symbol for "CONTAINS SUFFICIENT
FOR TESTS"
A.9 Example of use of symbol for "UPPER LIMIT OF
TEMPERATURE"
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 Standard
addressing essential requirements or other
provisions of the European Parliament and the
Council Directive 98/79/EC on in vitro
diagnostic medical devices
Bibliography