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ISO 15223-2:2010 Preview
Medical devices -- Symbols to be used with medical device labels, labelling, and information to be supplied -- Part 2: Symbol development, selection and validation
This standard was last reviewed and confirmed in 2016. Therefore this version remains current.
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.
General information
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Status : PublishedPublication date : 2010-01
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Edition : 1Number of pages : 16
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Technical Committee:Quality management and corresponding general aspects for medical devices
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- ICS :
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Graphical symbols for use on specific equipment
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Medical equipment in general
Buy this standard
| Format | Language | |
|---|---|---|
| Paper |
- CHF88
Life cycle
A standard is reviewed every 5 years
Revisions / Corrigenda
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Previously
ISO 15223:2000
ISO 15223:2000/Amd 1:2002
ISO 15223:2000/Amd 2:2004
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Now confirmed
ISO 15223-2:2010
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