Most recent

DIN EN 13612:2002

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 responsibilities and general requirements for the planning, conduct, assessment and documentation of a performance evaluation study by the manufacturer. It does not give specific performance study protocols for single IVD MDs or a specific use.

CONTENT PROVIDER
Deutsches Institut für Normung [din]

Others Also Bought
Information supplied by the manufacturer with in vitro diagnostic reagents for professional use; English version ...
Stability testing of in vitro diagnostic reagent (Foreign Standard)
Elimination or reduction of risk of infection related to in vitro diagnostic reagents
Included in Packages
This standard is not included in any packages.
Document History
We have no document history for this standard.
Amendments & Corrections
We have no amendments or corrections for this standard.