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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded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