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08/30154605 DC : DRAFT APR 2008

Superseded

Superseded

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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

Published date

11-23-2012

Superseded date

06-30-2010

Superseded by

BS ISO 15223-2:2010

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Summarise this standard

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Superseded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

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