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sklademVydáno: 2010
ISO 15223-2:2010
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
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Označení normy: | ISO 15223-2:2010 |
Počet stran: | 16 |
Vydání: | 1 |
Vydáno: | 2010 |
Popis
ISO 15223-2:2010
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.