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 already in use
5.1 General
5.2 Symbol for 'DO NOT REUSE'
5.3 Symbol for 'USE BY'
5.4 Symbol for 'BATCH CODE'
5.5 Symbol for 'SERIAL NUMBER'
5.6 Symbol for 'DATE OF MANUFACTURE'
5.7 Symbol for 'STERILE'
5.8 Symbols for 'STERILE', including the method of
sterilization
5.9 Symbol for 'STERILE USING ASEPTIC PROCESSING TECHNIQUES'
5.10 Symbol for 'CATALOGUE NUMBER'
5.11 Symbol for 'CAUTION'
5.12 Symbol for 'MANUFACTURER'
5.13 Symbol for 'AUTHORISED REPRESENTATIVE IN THE EUROPEAN
COMMUNITY'
5.14 Symbol for ' SUFFICIENT FOR '
5.15 Symbol for 'FOR IVD PERFORMANCE EVALUATION ONLY'
5.16 Symbol for 'IN VITRO DIAGNOSTIC MEDICAL DEVICE'
5.17 Symbols for 'TEMPERATURE LIMITS' including indication of
limits of temperature
5.18 Symbol for 'CONSULT INSTRUCTIONS FOR USE'
5.19 Symbol for 'BIOLOGICAL RISKS'
5.20 Symbol for 'KEEP AWAY FROM SUNLIGHT'
5.21 Symbol for 'KEEP DRY'
5.22 Symbol for 'DO NOT RESTERILIZE'
5.23 Symbol for 'NON-STERILE'
5.24 Symbol for 'CONTROL'
5.25 Symbol for 'NEGATIVE CONTROL'
5.26 Symbol for 'POSITIVE CONTROL'
6 New symbols
6.1 General
6.2 Symbol for 'CONTAINS OR PRESENCE OF NATURAL RUBBER LATEX'
6.3 Symbol for 'DO NOT USE IF PACKAGE IS DAMAGED'
6.4 Symbol for 'STERILE FLUID PATH'
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 Example of use of symbol for 'MANUFACTURER'
A.7 Example of use of symbol for 'MANUFACTURER' combined
with 'DATE OF MANUFACTURE'
A.8 Example of use of symbol for ' AUTHORISED REPRESENTATIVE
IN THE EUROPEAN COMMUNITY'
A.9 Examples of use of symbol for ' SUFFICIENT FOR'
A.10 Example of use of symbol for 'UPPER LIMIT OF TEMPERATURE'
A.11 Example of use of symbol for 'LOWER LIMIT OF TEMPERATURE'
A.12 Example of use of symbol for 'TEMPERATURE LIMITATION'
A.13 Examples of use of symbol for 'STERILE FLUID PATH'
Annex B (informative) Use of the general prohibition symbol and the
negation symbol
B.1 The general prohibition symbol
B.2 The 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) 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