BS ISO 15223-2:2010
Current
The latest, up-to-date edition.
Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied Symbol development, selection and validation
Hardcopy , PDF
English
30-06-2010
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principles for identification and development
of new symbols
5 Process for selecting and validating symbols for
inclusion in ISO 15223-1
6 Classification of risk
7 Concept development
8 Evaluation
9 Acceptance criteria
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
Annex C (normative) - IEC/SC 3C proposal for graphical
symbol form
Bibliography
Describes a process for developing, selecting and validating symbols for inclusion in ISO 15223-1.
| Committee |
CH/210/3
|
| DevelopmentNote |
Supersedes 08/30154605 DC. (06/2010)
|
| DocumentType |
Standard
|
| Pages |
28
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This part of ISO15223 specifies a process for developing, selecting and validating symbols for inclusion in ISO15223-1.
The purpose of this part of ISO15223 is to ensure that symbols included in ISO15223-1 are readily understood by the target group.
If the symbol validation process detailed in this part of ISO15223 has been complied with, then the residual risks, as defined in ISO14971 and IEC62366, associated with the usability of a medical device symbol are presumed to be acceptable, unless there is objective evidence to the contrary.
This part of ISO15223 is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.
| Standards | Relationship |
| ISO 15223-2:2010 | Identical |
| 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 |
| ISO 9186-1:2014 | Graphical symbols — Test methods — Part 1: Method for testing comprehensibility |
| 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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