08/30154605 DC : DRAFT APR 2008
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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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
23-11-2012
30-06-2010
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Superseded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 |