Logo
Login Sign Up
Current Consolidated

BSI BS EN 13612:2002

Performance evaluation of in vitro diagnostic medical devices
Best Price Guarantee
Instant

$217.82

2-5 Days

$217.82

SAVE 10%

$392.08


Sub Total (1 Item(s))

$ 0.00

Estimated Shipping

$ 0.00

Total (Pre-Tax)

$ 0.00


or
British Standards Institution Logo

BSI BS EN 13612:2002

Performance evaluation of in vitro diagnostic medical devices

PUBLISH DATE 2003
PAGES 18
BSI BS EN 13612:2002
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.
SDO BSI: British Standards Institution
Document Number EN 13612
Publication Date Feb. 27, 2003
Language en - English
Page Count 18
Revision Level
Supercedes
Committee CH/212
Publish Date Document Id Type View
May 7, 2002 BS EN 13612:2002 Revision
Feb. 27, 2003 BS EN 13612:2002 Consolidated