IVDD相关标准
IVDD产品欧洲协调标准：
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-testin
EN13612: Performance evaluation of IVD medical devices
EN13641: Elimination or reduction of risk of infection related to IVD reagents
prEN13975: Sampling procedures used for acceptance testing of IVD—Statistical aspects
DRAFT prEN ISO18153: IVD—measurement of quantities—metrological traceability of values for catalytic concentration of enzymes
