SIST EN 13612:2002

Oznaka standarda: SIST EN 13612:2002
Koda projekta: 00140037
Organizacija: SIST
Naslov (angleški): Performance evaluation of in vitro diagnostic medical devices
Naslov (slovenski): Ovrednotenje diagnostičnih medicinskih pripomočkov lastnosti in vitro
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SIST EN 13612:2002 angleški jezik Active SIST-D: 44.00 EUR
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Tehnični odbor: VAZ - Varovanje zdravja
ICS: 11.100.10
Status: Objavljen
Objavljen: 01-nov-2002
Refer. št. objave: Sporocila 2002-11-01
Področje projekta (angleško): 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.
Povezava na standarde
Povezava Ime Datum
Popravljen z SIST EN 13612:2002/AC:2003 - Ovrednotenje diagnostičnih medicinskih pripomočkov lastnosti in vitro 22-dec-2008


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