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Homepage>ISO Standards>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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download between 0-24 hoursReleased: 2010
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

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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English PDF
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115.00 EUR
English Hardcopy
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French PDF
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French Hardcopy
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Standard´s number:ISO 15223-2:2010
Pages:16
Edition:1
Released:2010
DESCRIPTION

ISO 15223-2:2010


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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