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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

Jan 15, 2010

General information

90.20     Jul 15, 2021

ISO

ISO/TC 210

International Standard

01.080.20     11.040.01  

French   English  

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Scope

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.

Life cycle

PREVIOUSLY

Revises
ISO 15223:2000

Revises
ISO 15223:2000/Amd 1:2002

Revises
ISO 15223:2000/Amd 2:2004

NOW

PUBLISHED
ISO 15223-2:2010
90.20 Standard under periodical review
Jul 15, 2021

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