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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

standard by International Organization for Standardization, 01/15/2010

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Full Description

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.

 

Product Details

Published:
01/15/2010
File Size:
1 file , 770 KB
Same As:
BS ISO 15223-2:2010, AAMI/ISO 15223-2:2010, BS ISO 15223-2:2010
 

Document History

  1. ISO 15223-2:2010

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    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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  2. ISO 15223:2000


    Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied

    • Historical Version