Most recent

BS ISO 15223-2:2010

Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Symbol development, selection and validation (British Standard)

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.

CONTENT PROVIDER
British Standards Institution [bsi]

Others Also Bought
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part ...
Comprehensive guide to steam sterilization and sterility assurance in health care facilities. (Consolidated te ...
AAMI TIR12 / ANSI/AAMI ST81 Set
Included in Packages
This standard is not included in any packages.
Document History
We have no document history for this standard.
Amendments & Corrections
We have no amendments or corrections for this standard.