BS EN 980:2008
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Symbols for use in the labelling of medical devices
Hardcopy , PDF
31-07-2012
English
30-06-2008
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.
Committee |
CH/210/3
|
DevelopmentNote |
Supersedes 93/500392 DC. (02/2002) Supersedes 02/563809 DC. (08/2003) Supersedes 00/565621 DC & 93/500392 DC. (03/2007) 2003 Version remains current and will be withdrawn on 31/05/2010. Supersedes 06/30122245 DC. (06/2008)
|
DocumentType |
Standard
|
Pages |
38
|
PublisherName |
British Standards Institution
|
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 |
SN EN 980 : 2008 | Identical |
DIN EN 980:2008-08 | Identical |
UNE-EN 980:2008 | Identical |
I.S. EN 980:2008 | Identical |
NS EN 980 : 3ED 2008 | Identical |
DIN EN 980:2003-08 | Identical |
BS EN 1283:1996 | Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits |
BS EN 1658:1997 | Requirements for marking of in vitro diagnostic instruments |
BS 7143:1989 | Specification for catheter mounts (flexible adaptors) for use with medical breathing systems |
BS 6155:1990 | Specification for tracheal tubes for large animals in veterinary anaesthesia |
BS EN 1617:1997 | Sterile drainage catheters and accessory devices for single use |
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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