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 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.
Document published on: 2010-01-15 Edition: 1 (Monolingual) ICS: 01.080.20; 11.040.01 Status: Published Stage: 90.60 (2015-06-17) 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
No corrigenda or amendments available