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

Publication date: Jan 15, 2010

General information

Current stage: 90.92 Effective date: Aug 26, 2022

Originator: ISO

Owner: ISO/TC 210

Type: International Standard

ICS: 01.080.20 11.040.01

Languages: English French

Buying

Status: Published

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Paper - EC$276.92

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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
90.92 Standard to be revised
Aug 26, 2022

REVISED BY

IN_DEVELOPMENT
ISO/AWI 15223-2

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