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Стандарт и/или проект Этап ТК
ISO 13079:2011
Laboratory glass and plastics ware — Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method
90.93 ISO/TC 48
ISO 15193:2002
In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Presentation of reference measurement procedures
95.99 ISO/TC 212
ISO 15193:2009
In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for content and presentation of reference measurement procedures
90.93 ISO/TC 212
ISO 15194:2002
In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Description of reference materials
95.99 ISO/TC 212
ISO 15194:2009
In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for certified reference materials and the content of supporting documentation
90.93 ISO/TC 212
ISO 15197:2003
In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
95.99 ISO/TC 212
ISO 15197:2013
In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
90.93 ISO/TC 212
ISO 15198:2004
Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
90.60 ISO/TC 212
ISO 16256:2012
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
90.92 ISO/TC 212
ISO/NP 16256
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
10.99 ISO/TC 212
ISO 17511:2003
In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values assigned to calibrators and control materials
90.92 ISO/TC 212
ISO/FDIS 17511
In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
50.00 ISO/TC 212
ISO/TR 18112:2006
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
ISO 18113-1:2009
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
90.93 ISO/TC 212
ISO 18113-2:2009
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
90.93 ISO/TC 212
ISO 18113-3:2009
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
90.93 ISO/TC 212
ISO 18113-4:2009
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
90.93 ISO/TC 212
ISO 18113-5:2009
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
90.93 ISO/TC 212
ISO 18153:2003
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 ISO/TC 212
ISO 19001:2002
In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
95.99 ISO/TC 212
ISO 19001:2013
In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
90.93 ISO/TC 212
ISO 20166-1:2018
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 1: Isolated RNA
60.60 ISO/TC 212
ISO 20166-2:2018
Molecular in vitro diagnostic examinations — Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 2: Isolated proteins
60.60 ISO/TC 212
ISO 20166-3:2018
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 3: Isolated DNA
60.60 ISO/TC 212
ISO 20184-1:2018
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 1: Isolated RNA
60.60 ISO/TC 212
ISO 20184-2:2018
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 2: Isolated proteins
60.60 ISO/TC 212
ISO 20186-1:2019
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNA
60.60 ISO/TC 212
ISO 20186-2:2019
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA
60.60 ISO/TC 212
ISO 20186-3:2019
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 ISO/TC 212
ISO 20916:2019
In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
60.60 ISO/TC 212
ISO/DIS 21151
In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for international harmonization protocols establishing metrological traceability of values assigned to calibrators and human samples
40.60 ISO/TC 212
ISO/DIS 21474-1
In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluation
40.20 ISO/TC 212
ISO 23640:2011
In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
90.93 ISO/TC 212
ISO 29701:2010
Nanotechnologies — Endotoxin test on nanomaterial samples for in vitro systems — Limulus amebocyte lysate (LAL) test
90.93 ISO/TC 229

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