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

BS EN 13612:2002

Performance evaluation of in vitro diagnostic medical devices

Status : Current, Confirmed   Published : May 2002
Conformity to regulation : Designated



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, Confirmed
Publication Date07 May 2002
Conformity to regulationDesignated
Confirm Date20 February 2020
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
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

 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents

Tracked Changes

Understand the changes made to a standard with our new Tracked Changes version

Develop a PAS

Develop a fast-track standardization document in 9-12 months


Access, view and download standards with multiple user access, across multiple sites with BSOL

Customers who bought this product also bought

  • BS EN 13975:2003
    Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects
  • BS EN 13641:2002
    Elimination or reduction of risk of infection related to in vitro diagnostic reagents
  • BS EN ISO 18113-1:2011
    In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements
  • BS EN ISO 18113-2:2011
    In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for professional use