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Norma o proyecto | Etapa | TC |
---|---|---|
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated human DNA
|
60.60 | ISO/TC 212 |
Medical laboratories — Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests
|
50.00 | ISO/TC 212 |
In vitro diagnostic medical devices — Single-use containers for the collection of specimens from humans other than blood
|
60.60 | ISO/TC 76 |
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood — Part 1: Isolated RNA
|
50.20 | ISO/TC 212 |
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood — Part 2: Isolated DNA
|
50.20 | ISO/TC 212 |
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood — Part 3: Preparations for analytical CTC staining
|
50.20 | ISO/TC 212 |
Laboratory glass and plastics ware — Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method
|
90.93 | ISO/TC 48/SC 8 |
In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Presentation of reference measurement procedures
|
95.99 | 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 | ISO/TC 212 |
In vitro diagnostic medical devices — Requirements for reference measurement procedures
|
50.00 | ISO/TC 212 |
In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Description of reference materials
|
95.99 | 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 | ISO/TC 212 |
In vitro diagnostic medical devices — Requirements for certified reference materials and the content of supporting documentation
|
50.00 | ISO/TC 212 |
In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
|
95.99 | ISO/TC 212 |
In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
|
90.60 | ISO/TC 212 |
Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
|
90.60 | ISO/TC 212 |
Clinical laboratory testing and in vitro diagnostic test systems — Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
|
95.99 | 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 | ISO/TC 212 |
Manufacturers’ considerations for in vitro diagnostic medical devices in a public health emergency
|
50.00 | ISO/TC 212 |
In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values assigned to calibrators and control materials
|
95.99 | 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 | ISO/TC 212 |
Clinical laboratory testing and in vitro diagnostic test systems — In vitro diagnostic medical devices for professional use — Summary of regulatory requirements for information supplied by the manufacturer
|
95.99 | ISO/TC 212 |
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
|
95.99 | ISO/TC 212 |
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements
|
60.60 | ISO/TC 212 |
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
|
95.99 | 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 | ISO/TC 212 |
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
|
95.99 | 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 | ISO/TC 212 |
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
|
95.99 | 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 | ISO/TC 212 |
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
|
95.99 | 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 | 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 | ISO/TC 212 |
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for urine and other body fluids — Isolated cell free DNA
|
30.99 | ISO/TC 212 |
In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
|
95.99 | ISO/TC 212 |
In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
|
90.93 | 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 | 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 | 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 | 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 | ISO/TC 212 |
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 1: Isolated RNA
|
90.60 | ISO/TC 212 |
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 2: Isolated proteins
|
90.60 | ISO/TC 212 |
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 3: Isolated DNA
|
60.60 | ISO/TC 212 |
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNA
|
90.60 | ISO/TC 212 |
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA
|
90.60 | 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
|
90.20 | ISO/TC 212 |
In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
|
90.20 | ISO/TC 212 |
In vitro diagnostic medical devices — Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples
|
60.60 | ISO/TC 212 |
In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluation
|
60.60 | ISO/TC 212 |
In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification
|
60.60 | ISO/TC 212 |
In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 3: Interpretation and reports
|
50.00 | ISO/TC 212 |
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma
|
60.60 | ISO/TC 212 |
In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
|
90.92 | ISO/TC 212 |
Nanotechnologies — Endotoxin test on nanomaterial samples for in vitro systems — Limulus amebocyte lysate (LAL) test
|
90.93 | ISO/TC 229 |
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