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体外诊断医疗器械指令IVDD98/79/EC返回首页

IVD产品欧洲协调标准:

标准号

          

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

IVDmeasure of quantitiesdescription of reference materials

EN12286

IVDmeasure of quantitiespresentation 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 IVDStatistical aspects

DRAFT

prEN14136

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

DRAFT prEN ISO18153

IVDmeasurement of quantitiesmetrological traceability of values for catalytic concentration of enzymes

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