09/30176675 DC : 0

Superseded

BS EN ISO 15223-1 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS

Available format(s)

Hardcopy , PDF

Superseded date

31-07-2012

Language(s)

English

Publisher

British Standards Institution

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
  5.1 Manufacture
  5.2 Sterility
  5.3 Storage
  5.4 Safe Use
  5.5 IVD-specific
  5.6 Transfusion/infusion
  5.7 Other
Annex A (informative) - Examples
Annex B (informative) - Use of general prohibition symbol
        and 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) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 90/385/EEC on Active Implantable Medical
          Devices
Annex ZC (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 98/79/EC on In vitro Diagnostic Medical
         Devices
Bibliography

BS EN ISO 15223-1

Committee	CH/210/3
DocumentType	Draft
Pages	45
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN ISO 15223-1:2016

ISO 7010:2011	Graphical symbols Safety colours and safety signs Registered safety signs
EN 591 : 2001	INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE
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
IEC 62366:2007+AMD1:2014 CSV	Medical devices - Application of usability engineering to medical devices
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
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/TR 7239:1984	Development and principles for application of public information symbols
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 7000:2014	Graphical symbols for use on equipment Registered symbols
EN 980:2008	Symbols for use in the labelling of medical devices