• There are no items in your cart

NBN EN 980 : 2008

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES

Superseded date

01-08-2012

Published date

12-01-2013

Sorry this product is not available in your region.

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

Defines graphical symbols to be used on information supplied with medical devices by the manufacturer.

DocumentType
Standard
PublisherName
Belgian Standards
Status
Superseded

Standards Relationship
DIN EN 980:2003-08 Identical
UNE-EN 980:2008 Identical
I.S. EN 980:2008 Identical
BS EN 980:2008 Identical
DIN EN 980:2008-08 Identical
EN 980:2008 Identical

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.