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AAMI/ISO 15223-2:2016
Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 2: Symbol development, selection and validationMore info
This part of ISO 15223 specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1. The purpose of this part of ISO 15223 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.
| Author | ANSI/AAMI/ISO |
|---|---|
| Editor | AAMI |
| Document type | Standard |
| Format | File |
| Confirmation date | 2016-04-07 |
| ICS | 01.080.20 : Graphical symbols for use on specific equipment 11.040.01 : Medical equipment in general |
| Replace | ANSI/AAMI/ISO 15223-2 (2010) |
| Cross references | ISO 15223-2 (2010-01), IDT |
| Year | 2016 |
| Document history | ANSI/AAMI/ISO 15223-2 (2016) |
| Country | USA |
| Keyword | ANSI 15223;ANSI/AAMI/ISO 15223;15223;ANSI/AAMI/ISO 15223-2-2016 |