ISO 15223-2:2010
Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
This standard has an identical version adopted as a Singapore Standard. The adopted Singapore version has the same content as this version and is available at a significantly lower cost. To view and / or purchase the adopted Singapore Version, click here .
OVERVIEW
ISO 15223-2:2010 specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1.
The purpose of ISO 15223-2:2010 is to ensure that symbols included in ISO 15223-1 are readily understood by the target group.
If the symbol validation process detailed in ISO 15223-2:2010 has been complied with, then the residual risks, as defined in ISO 14971 and IEC 62366, associated with the usability of a medical device symbol are presumed to be acceptable, unless there is objective evidence to the contrary.
ISO 15223-2:2010 is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2010 |
| No. of Pages | 16 |
| ICS Classification | 11.040.01 Medical equipment in general 01.080.20 Graphical symbols for use on specific equipment |
| Committee | ISO/TC 210 |
| Available for Purchase | For sale in Singapore only |
| Adoption | ISO |