IVD產(chǎn)品歐洲協(xié)調標準：
|
標準號 |
內 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 |
