标准号

内           容

EN375

Information supplied by manufacturer with IVD for professional use

EN376

Information supplied by manufacturer with IVD for self-testing

EN591

Instruction for use for IVD instruments for professional use

EN592

Instruction for use for IVD instruments for self-testing

EN12287

IVD—measure of quantities—description of reference materials

EN12286

IVD—measure of quantities—presentation of reference measurement procedures

EN13532

General requirements for IVD medical devices for self-testing

EN13612

Performance evaluation of IVD medical devices

EN13641

Elimination or reduction of risk of infection related to IVD reagents

DRAFT

prEN13975

Sampling procedures used for acceptance testing of IVD—Statistical aspects

DRAFT

prEN14136

Use of external quality assessment schemes in the assessment of the performance of IVD procedures

DRAFT prEN ISO18153

IVD—measurement of quantities—metrological traceability of values for catalytic concentration of enzymes