ISO-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

ISO-15223-2 - 1ST EDITION - CURRENT


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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.

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To find similar documents by classification:

01.080.20 (Graphical symbols for use on specific equipment Standards included in this group shall also be included in other groups and/or sub-groups according to their subject)

11.040.01 (Medical equipment in general)

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Document Number

ISO 15223-2:2010

Revision Level

1ST EDITION

Status

Current

Publication Date

Jan. 15, 2010

Committee Number

ISO/TC 210