New ISO standard for safer use of symbols with medical devices
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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
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Abstract
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.
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Edition: 1 (Monolingual) ICS: 01.080.20; 11.040.01 Status: Published Stage: 60.60 (2010-01-15) TC/SC: ISO/TC 210 Number of Pages: 16 -
Revises: ISO 15223:2000
Revises: ISO 15223:2000/Amd 1:2002
Revises: ISO 15223:2000/Amd 2:2004
