ISO 15223-2:2010
Current
Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
Hardcopy , PDF
English, French
01-15-2010
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.
| Committee |
ISO/TC 210
|
| DevelopmentNote |
Supersedes ISO/DIS 15223-2. Together with ISO 15223-1 supersedes ISO 15223. (01/2010)
|
| DocumentType |
Standard
|
| Pages |
16
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NEN ISO 15223-2 : 2010 | Identical |
| AAMI ISO 15223-2 : 2010 | Identical |
| NF ISO 15223-2 : 2010 | Identical |
| BS ISO 15223-2:2010 | Identical |
| SS-ISO 15223-2:2017 | Identical |
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