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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

90.20 Standard under periodical review

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

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 1: Isolated RNA

90.60 Close of review

ISO/TC 212

Molecular in vitro diagnostic examinations — Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 2: Isolated proteins

90.60 Close of review

ISO/TC 212

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 3: Isolated DNA

90.60 Close of review

ISO/TC 212

Molecular in vitro diagnostic examinations — Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 4: In situ detection techniques

60.60 Standard published

ISO/TC 212

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 1: Isolated RNA

90.60 Close of review

ISO/TC 212

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 2: Isolated proteins

90.60 Close of review

ISO/TC 212

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 3: Isolated DNA

60.60 Standard published

ISO/TC 212

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNA

90.20 Standard under periodical review

ISO/TC 212

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA

90.20 Standard under periodical review

ISO/TC 212

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma

60.60 Standard published

ISO/TC 212

In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice

90.20 Standard under periodical review

ISO/TC 212