SS-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, IDT)

SS-ISO-15223-2 - 2017 EDITION - CURRENT


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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. This part of ISO 15223 is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.

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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Designation Name

SS-ISO 15223-2:2017

Revision Level

2017 EDITION

Status

Current

Publication Date

April 18, 2017

Language(s)

English

Page Count

32

International Equivalent

ISO 15223-2(IDT)