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08/30154605 DC : DRAFT APR 2008

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BS ISO 15223-2 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 2: SYMBOL DEVELOPMENT, SELECTION AND VALIDATION
Superseded date

06-30-2010

Published date

11-23-2012

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principles for identification, development and
  selection of new symbols
  4.1 Identifying the need for a symbol
  4.2 Symbols with horizontal applications
  4.3 Symbols for use within a restricted range of
      device types
  4.4 Symbol development process
      4.4.1 General
      4.4.2 Initial evaluation
      4.4.3 Second evaluation
5 Classification of risk
6 Concerpt development
  6.1 Existence of other symbols
  6.2 Symbol design
7 Evaluation
  7.1 Testing early symbol concepts
  7.2 Comprehension testing
  7.3 Memory testing
  7.4 Usability testing
8 Acceptance criteria
  8.1 General
  8.2 Symbols with no to low safety relevance
  8.3 Symbols with moderate to high safety relevance
Annex A (normative) - Information to be provided during
        the symbol development process for adoption of
        a symbol into ISO 15223-1
Annex B (normative) - ISO/TC 145/SC 3 Proposal for graphical
        symbols
  B.1 ISO/TC 145 Symbol proposal form
  B.2 Basic pattern for symbol design
  B.3 ISO/TC 145 registration process steps
Annex C (normative) - IEC/SC 3 Proposal for graphical symbol
        form
Bibliography

Committee
CH/210/3
DocumentType
Draft
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

ISO 9186:2001 Graphical symbols Test methods for judged comprehensibility and for comprehension
ISO 7010:2011 Graphical symbols Safety colours and safety signs Registered safety signs
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
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 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
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
EN 980:2008 Symbols for use in the labelling of medical devices

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