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In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media

90.60 Close of review

CEN/TC 140

In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media

60.60 Standard published

CEN/TC 140

General requirements for in vitro diagnostic medical devices for self-testing

90.93 Standard confirmed

CEN/TC 140

Performance evaluation of in vitro diagnostic medical devices

60.60 Standard published

CEN/TC 140

Performance evaluation of in vitro diagnostic medical devices

90.93 Standard confirmed

CEN/TC 140

Elimination or reduction of risk of infection related to in vitro diagnostic reagents

90.93 Standard confirmed

CEN/TC 140

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

90.93 Standard confirmed

CEN/TC 140

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

90.93 Standard confirmed

CEN/TC 140

Medical laboratories - Requirements for quality and competence

60.60 Standard published

CEN/TC 140

Medical laboratories - Requirements for quality and competence (ISO 15189:2022)

60.60 Standard published

CEN/TC 140

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)

90.92 Standard to be revised

CEN/TC 140

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009)

90.93 Standard confirmed

CEN/TC 140

Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)

60.60 Standard published

CEN/TC 140

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)

60.60 Standard published

CEN/TC 140

Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases (ISO 16256:2021)

60.60 Standard published

CEN/TC 140

In vitro diagnostic systems - Culture media for microbiology - Terms and definitions

90.60 Close of review

CEN/TC 140

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 1: Isolated RNA

60.60 Standard published

CEN/TC 140

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 2: Isolated DNA

60.60 Standard published

CEN/TC 140