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Norm
ÖNORM EN 13612
Issue date: 2002 08 01
Performance evaluation of in vitro diagnostic medical devices
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 respon...
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Valid
Publisher:
Austrian Standards International
Format:
Digital | 15 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
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.