BS ISO 15223-2:2010 specifies a process for developing, selecting and validating symbols for inclusion in
ISO 15223-1.
The purpose of BS 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 this part of ISO 15223 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.
BS ISO 15223-2:2010 is not restricted to symbols intended to meet regulatory requirements or specified in
regulatory guidelines on labelling.
Cross References:ISO 9186-1:2007
ISO 15223-1:2007
ISO 80416-2
IEC 80416-1:2008
ISO 7000
ISO 7010
ISO/TR 7239
ISO 14971
ISO 15225
IEC 60417-DB
IEC/TR 60878
IEC 80416-3
EN 980
IEC 62366
All current amendments available at time of purchase are included with the purchase of this document. | File Size : | 1
file
, 910 KB |
| ISBN(s) : | 9780580575327 |
| Note : | This product is unavailable in Russia, Ukraine, Belarus |
| Number of Pages : | 28 |
| Product Code(s) : | 30154607, 30154607, 30154607 |
| Published : | 06/30/2010 |
| Same As : | BS ISO 15223-2:2010 |
