Проект комитета
ISO/CD 15223-2
Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
Ссылочный номер
ISO/CD 15223-2
Версия 2
Проект комитета
ISO/CD 15223-2
90574
Проект данного международного стандарта рассматривается комитетом.
Текущее издание: ISO 15223-2:2010

Тезис

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.

Общая информация

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    : Регистрация проекта комитета (CD) [30.00]
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  • ISO/TC 210
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