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I.S. 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Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Available format(s)

Hardcopy , PDF

Superseded date

09-07-2012

Language(s)

English

Published date

01-01-2008

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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

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

DocumentType
Standard
Pages
36
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
NEN EN 980 : 2008 Identical
NF EN 980 : 2008 Identical
UNI EN 980 : 2004 Identical
EN 980:2008 Identical
NBN EN 980 : 2008 Identical
BS EN 980:2008 Identical
SN EN 980 : 2008 Identical
DIN EN 980:2008-08 Identical
NS EN 980 : 3ED 2008 Identical
UNE-EN 980:2008 Identical
DIN EN 980:2003-08 Identical

EN 80416-3:2002/A1:2011 BASIC PRINCIPLES FOR GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - PART 3: GUIDELINES FOR THE APPLICATION OF GRAPHICAL SYMBOLS
EN 80416-2:2001 Basic principles for graphical symbols for use on equipment - Part 2: Form and use of arrows
EN 591 : 2001 INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE
ISO 80416-4:2005 Basic principles for graphical symbols for use on equipment — Part 4: Guidelines for the adaptation of graphical symbols for use on screens and displays (icons)
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
EN 592 : 2002 INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING
EN 376 : 2002 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
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 80416-3:2002+AMD1:2011 CSV Basic principles for graphical symbols for use on equipment - Part 3: Guidelines for the application of graphical symbols
IEC 80416-1:2008 Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration
ISO 80416-2:2001 Basic principles for graphical symbols for use on equipment — Part 2: Form and use of arrows
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
ISO 3864-1:2011 Graphical symbols Safety colours and safety signs Part 1: Design principles for safety signs and safety markings
ISO 15225:2016 Medical devices Quality management Medical device nomenclature data structure
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
EN 80416-1:2009 Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
EN 12264:2005 Health informatics - Categorial structures for systems of concepts

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