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ISO/TC 212  - Clinical laboratory testing and in vitro diagnostic test systems

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Standards and projects under the direct responsibility of ISO/TC 212 Secretariat and its SCs

Standard and/or projectStageICSTC
ISO/NP 15190
Medical laboratories -- Requirements for safety
10.99 11.100.01ISO/TC 212
ISO/CD 15195
Laboratory medicine -- Requirements for the competence of calibration laboratories using reference measurement procedures
30.60 11.100.99ISO/TC 212
ISO/TS 16782
Clinical laboratory testing -- Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
60.00 11.100.20ISO/TC 212
ISO/NP 17511
In vitro diagnostic medical devices -- requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
10.99 11.100.10ISO/TC 212
ISO/DIS 20166-1
Molecular in vitro diagnostic examinations -- Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue -- Part 1: Isolated RNA
40.20 11.100.10ISO/TC 212
ISO/DIS 20166-2
Molecular in vitro diagnostic examinations -- Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue -- Part 2: Isolated proteins
40.20 11.100.10ISO/TC 212
ISO/DIS 20166-3
Molecular in vitro diagnostic examinations -- Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue -- Part 3: Isolated DNA
40.20 11.100.10ISO/TC 212
ISO/DIS 20184-1
Molecular in-vitro diagnostic examinations -- Specifications for pre-examination processes for frozen tissue -- Part 1: Isolated RNA
40.20 11.100.10ISO/TC 212
ISO/DIS 20184-2
Molecular in-vitro diagnostic examinations -- Specifications for pre-examination processes for frozen tissue -- Part 2: Isolated proteins
40.20 11.100.10ISO/TC 212
ISO/CD 20186-1
Molecular in-vitro diagnostic examinations -- Specifications for pre-examination processes for blood -- Cellular RNA -- Part 1: Isolated cellular RNA
30.99 11.100.10ISO/TC 212
ISO/CD 20186-2
Molecular in-vitro diagnostic examinations -- Specifications for pre-examination processes for blood -- Cellular RNA -- Part 2: Isolated genomic DNA correct
30.99 11.100.10ISO/TC 212
ISO/CD 20186-3
Molecular in-vitro diagnostic examinations -- Specifications for pre-examination processes for blood -- Cellular RNA -- Part 3: Isolated circulating cell free DNA from plasma
30.99 11.100.10ISO/TC 212
ISO/DTS 20658
Medical laboratory examinations -- Requirements for collection, transport, receipt, and handling of samples
30.60 11.100.01ISO/TC 212
ISO/NP 20776-1
Clinical laboratory testing and in vitro diagnostic test systems -- Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices -- Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases
10.99 11.100.20ISO/TC 212
ISO/NP TS 20914
Medical laboratories -- Practical guide for the estimation of measurement uncertainty
10.99ISO/TC 212
ISO/NP 20916
Clinical performance studies for in vitro diagnostic devices (IVDs) using specimens from human subjects -- Good study practice
10.99ISO/TC 212
ISO/NP 21151
In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Requirements for international harmonization protocols intended to establish metrological traceability of values assigned to product (end user) calibrators and patient samples
10.99ISO/TC 212
ISO/NP 21474
In vitro diagnostic medical devices -- General requirements and terminology for multiplex molecular testing
10.99ISO/TC 212
ISO/FDIS 22870
Point-of-care testing (POCT) -- Requirements for quality and competence
50.20 03.120.10
11.100.01
ISO/TC 212
ISO/NP 35001
Laboratory biorisk management system -- Requirements
10.99ISO/TC 212