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    • Home
    • ICS
    • Generalities. Terminology. Standardization. Documentation
    • Graphical Symbols
    • Graphical Symbols For Use On Specific Equipment
    • ISO 15223-2:2010

    Codes & Standards - Purchase

    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
    SKU: iso_042343_145340 Published by ISO Publication Year 2010 1 Edition 16 pages

    Product Details

    • Overview
    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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