0

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 ISO 15223-2:2010

Publication date:   Jan 15, 2010

General information

90.92 Standard to be revised   Aug 26, 2022

ISO

ISO/TC 210 Quality management and corresponding general aspects for medical devices

International Standard

01.080.20   Graphical symbols for use on specific equipment | 11.040.01   Medical equipment in general

Buying

Published

Language in which you want to receive the document.

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

WITHDRAWN
ISO 15223:2000

WITHDRAWN
ISO 15223:2000/Amd 1:2002

WITHDRAWN
ISO 15223:2000/Amd 2:2004

NOW

PUBLISHED
ISO 15223-2:2010
90.92 Standard to be revised
Aug 26, 2022

REVISED BY

ABANDON
ISO/WD 15223-2

IN_DEVELOPMENT
ISO/CD 15223-2