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  • BSI
    BS EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
    Edition: 2003
    $316.70
    / user per year

Description of BS EN 13612:2002 2003

This European Standard applies to the performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing. It specifies the responsibilities and general requirements for the planning, conduct, assessment and documentation of a performance evaluation study by the manufacturer. It does not apply to specific evaluation plans for certain IVD MDs or a specific use. NOTE For a selection of publications on specific evaluation plans see Bibliography. Where a manufacturer maintains a quality system this standard addresses the compliance with "design validation" and "design changes" as described in EN ISO 9001, EN 46001 and EN 928 especially considering the nature and use of IVD MDs. In particular, this standard applies to IVD MDs to - show evidence to notified bodies and national authorities by results of a performance evaluation that the IVD MD performs as claimed by the manufacturer, - establish adequate performance evaluation data originating from appropriate studies or resulting from available literature, and to - satisfy the requirements of a quality system for design validation.

Standard NumberBS EN 13612:2002
TitlePerformance evaluation of in vitro diagnostic medical devices
StatusConfirmed
Publication Date2003-02-27
Identical National Standard OfEN 13612:2002, EN 13612:2002
CorrectsBS EN 13612:2002
DescriptorsPatients, Diagnosis (medical), Performance testing, Diagnostic testing, Medical equipment, Clinical investigation instruments
ICS11.100.10 In vitro diagnostic test systems
CommitteeCH/212
ISBN0 580 39650 9
PublisherBSI
Pages18

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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