BS EN 13612:2002 - Performance evaluation of in vitro diagnostic medical devices – BSI British Standards

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BS EN 13612:2002

Performance evaluation of in vitro diagnostic medical devices

Status : Current, Under review   Published : May 2002



BS EN 13612:2002 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
  • satisfy the requirements of a quality system for design validation.

Standard NumberBS EN 13612:2002
TitlePerformance evaluation of in vitro diagnostic medical devices
StatusCurrent, Under review
Publication Date07 May 2002
Cross ReferencesEN 376:2002, EN 928, EN 12286, EN 12287, EN 46001, EN ISO 9000:2000, EN ISO 9001, EN ISO 13485, ISO 9000:2000, ISO 9001:2000, ISO 13485:1996, ISO 5725-1, 98/79/EC
International RelationshipsEN 13612:2002
Amended ByAMD 14302
Corrigendum, February 2003
DescriptorsPatients, Diagnosis (medical), Performance testing, Diagnostic testing, Medical equipment, Clinical investigation instruments
Title in FrenchDetermination des performances des dispositifs medicaux pour diagnostic in vitro
Title in GermanLeistungsbewertung von In-vitro-Diagnostika
ISBN0 580 39650 9
File Size309 KB

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