BS ISO 15223-2:2010

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.

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.