Projects

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Medical laboratories — Requirements for quality and competence

60.60 Standard published

ISO/TC 212

Medical laboratories — Requirements for safety

60.60 Standard published

ISO/TC 212

In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for content and presentation of reference measurement procedures

90.92 Standard to be revised

ISO/TC 212

In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for certified reference materials and the content of supporting documentation

90.92 Standard to be revised

ISO/TC 212

Laboratory medicine — Requirements for the competence of calibration laboratories using reference measurement procedures

90.60 Close of review

ISO/TC 212

In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

90.60 Close of review

ISO/TC 212

Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer

90.60 Close of review

ISO/TC 212

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

60.60 Standard published

ISO/TC 212

In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples

60.60 Standard published

ISO/TC 212

Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

60.60 Standard published

ISO/TC 212

In vitro diagnostic test systems — Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens — Laboratory quality practice guide

60.60 Standard published

ISO/TC 212

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements

60.60 Standard published

ISO/TC 212

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use

60.60 Standard published

ISO/TC 212

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use

60.60 Standard published

ISO/TC 212

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing

60.60 Standard published

ISO/TC 212

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing

60.60 Standard published

ISO/TC 212

In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials

90.93 Standard confirmed

ISO/TC 212

In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

90.93 Standard confirmed

ISO/TC 212