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
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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Scope
Normative references
Terms and definitions
Principles for identification and development of new symbols
Identifying the need for a symbol
Symbols with horizontal applications
Symbols for use within a restricted range of device types
Process for selecting and validating symbols for inclusion i
General
Initial evaluation
Second evaluation
Classification of risk
Concept development
Existence of other symbols
Symbol design
Evaluation
Testing early symbol concepts
Comprehension testing
Memory testing
Usability testing
Acceptance criteria
General
Symbols with no to low safety relevance
Symbols with moderate to high safety relevance
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Scope
Normative references
Terms and definitions
Principles for identification and development of new symbols
Identifying the need for a symbol
Symbols with horizontal applications
Symbols for use within a restricted range of device types
Process for selecting and validating symbols for inclusion i
General
Initial evaluation
Second evaluation
Classification of risk
Concept development
Existence of other symbols
Symbol design
Evaluation
Testing early symbol concepts
Comprehension testing
Memory testing
Usability testing
Acceptance criteria
General
Symbols with no to low safety relevance
Symbols with moderate to high safety relevance