EN 13612:2002

Performance evaluation of in vitro diagnostic medical devices

Publication date:   Jan 22, 2004

General information

90.93 Standard confirmed   Feb 20, 2020

CEN

CEN/TC 140 In vitro diagnostic medical devices

European Norm

11.100   Laboratory medicine

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Scope

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.

Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting

Life cycle

NOW

PUBLISHED
EN 13612:2002
90.93 Standard confirmed
Feb 20, 2020

CORRIGENDA / AMENDMENTS

PUBLISHED
EN 13612:2002/AC:2002