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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

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Publication date: 2010-01-15
Price: 103 vnd

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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 identifier
ISO 15223-2:2010
Title
Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
ISO Category
TC 210: Quality management and corresponding general aspects for medical devices
Publication date
2010-01-15
Status
Effective
International Relationship
BS ISO 15223-2:2010 * AAMI/ISO 15223-2:2010 * BS ISO 15223-2:2010
Cross references
Latest version
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
Document identifier ISO 15223-2:2010
Publication date 2010-01-15
Classification 01.080.20. Graphical symbols for use on specific equipment
11.040.01. Medical equipment in general
Status Effective
*
History of version
ISO 15223-2:2010 * ISO 15223:2000
Keywords
Classification
01.080.20. Graphical symbols for use on specific equipment
11.040.01. Medical equipment in general
Pages
Price 103 vnd

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