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

Datum objavljivanja: 15. 1. 2010.

Опште информације

Trenutna faza: 90.92 Effective date: 26. 8. 2022.

Inicijator: ISO

Pripada: ISO/TC 210

Vrsta: Međunarodni standard

ICS: 01.080.20 11.040.01

Jezik: engleski francuski

Kupovina

Status: Objavljen

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Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 15223:2000

POVUČEN
ISO 15223:2000/Amd 1:2002

POVUČEN
ISO 15223:2000/Amd 2:2004

TRENUTNO

OBJAVLJEN
ISO 15223-2:2010
90.92 Odluka o izmeni ili reviziji standarda
26. 8. 2022.

REVIDIRAN OD

NAPUŠTEN
ISO/WD 15223-2

PROJEKAT
ISO/CD 15223-2