Standards catalogue

ISO/TC 212

Clinical laboratory testing and in vitro diagnostic test systems

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Standard and/or project under the direct responsibility of ISO/TC 212 Secretariat Stage ICS
ISO 15189:2003 [Withdrawn]
Medical laboratories -- Particular requirements for quality and competence
95.99
ISO 15189:2007 [Withdrawn]
Medical laboratories -- Particular requirements for quality and competence
95.99
ISO 15189:2012
Medical laboratories -- Requirements for quality and competence
90.20
ISO 15190:2003
Medical laboratories -- Requirements for safety
90.92
ISO/NP 15190 [Under development]
Medical laboratories -- Requirements for safety
10.99
ISO 15193:2002 [Withdrawn]
In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Presentation of reference measurement procedures
95.99
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ISO 15194:2002 [Withdrawn]
In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Description of reference materials
95.99
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 15195:2003
Laboratory medicine -- Requirements for reference measurement laboratories
90.92
ISO/CD 15195 [Under development]
Laboratory medicine -- Requirements for the competence of calibration laboratories using reference measurement procedures
30.60
ISO 15197:2003 [Withdrawn]
In vitro diagnostic test systems -- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
95.99
ISO 15197:2013
In vitro diagnostic test systems -- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
60.60
ISO 15198:2004
Clinical laboratory medicine -- In vitro diagnostic medical devices -- Validation of user quality control procedures by the manufacturer
90.60
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
90.20
ISO/TS 16782:2016
Clinical laboratory testing -- Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
60.60
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/NP 17511 [Under development]
In vitro diagnostic medical devices -- requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
10.99
ISO/TS 17518:2015
Medical laboratories -- Reagents for staining biological material -- Guidance for users
60.60
ISO 17593:2007
Clinical laboratory testing and in vitro medical devices -- Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
90.60
ISO/TS 17822-1:2014
In vitro diagnostic test systems -- Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens -- Part 1: General requirements, terms and definitions
90.20
ISO/NP 17822-2 [Under development]
In vitro diagnostic test systems -- Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens -- Part 2: Quality practices for nucleic acid amplification
10.99
ISO/TR 18112:2006 [Withdrawn]
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 18113-1:2009
In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 1: Terms, definitions and general requirements
90.93
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 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 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 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 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
90.60
ISO 19001:2002 [Withdrawn]
In vitro diagnostic medical devices -- Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
95.99
ISO 19001:2013
In vitro diagnostic medical devices -- Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
60.60
ISO/DIS 20166-1 [Under development]
Molecular in vitro diagnostic examinations -- Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue -- Part 1: Isolated RNA
40.99
ISO/DIS 20166-2 [Under development]
Molecular in vitro diagnostic examinations -- Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue -- Part 2: Isolated proteins
40.99
ISO/DIS 20166-3 [Under development]
Molecular in vitro diagnostic examinations -- Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue -- Part 3: Isolated DNA
40.99
ISO/DIS 20184-1 [Under development]
Molecular in-vitro diagnostic examinations -- Specifications for pre-examination processes for frozen tissue -- Part 1: Isolated RNA
40.99
ISO/DIS 20184-2 [Under development]
Molecular in-vitro diagnostic examinations -- Specifications for pre-examination processes for frozen tissue -- Part 2: Isolated proteins
40.99
ISO/DIS 20186-1 [Under development]
Molecular in vitro diagnostic examinations -- Specifications for pre-examination processes for venous whole blood -- Part 1: Isolated cellular RNA
40.99
ISO/DIS 20186-2 [Under development]
Molecular in vitro diagnostic examinations -- Specifications for pre-examination processes for venous whole blood -- Part 2: Isolated genomic DNA
40.99
ISO/DIS 20186-3 [Under development]
Molecular in-vitro diagnostic examinations -- Specifications for pre-examination processes for venous whole blood -- Cellular RNA -- Part 3: Isolated circulating cell free DNA from plasma
40.00
ISO/TS 20658:2017
Medical laboratories -- Requirements for collection, transport, receipt, and handling of samples
60.60
ISO 20776-1:2006
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
90.92
ISO/NP 20776-1 [Under development]
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
ISO 20776-2:2007
Clinical laboratory testing and in vitro diagnostic test systems -- Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices -- Part 2: Evaluation of performance of antimicrobial susceptibility test devices
90.60
ISO/NP TS 20914 [Under development]
Medical laboratories -- Practical guide for the estimation of measurement uncertainty
10.99
ISO/CD 20916 [Under development]
Clinical performance studies for in vitro diagnostic devices (IVDs) using specimens from human subjects -- Good study practice
30.99
ISO/NP 21151 [Under development]
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
10.99
ISO/CD 21474 [Under development]
In vitro diagnostic medical devices -- General requirements and terminology for multiplex molecular testing
30.60
ISO/CD 22367 [Under development]
Medical laboratories -- Reduction of error through risk management and continual improvement
30.60
ISO/TS 22367:2008
Medical laboratories -- Reduction of error through risk management and continual improvement
90.93
60.60
ISO/NP TS 22583 [Under development]
Guidance for supervisors and operators of point-of-care testing (POCT) devices
10.99
ISO/TR 22869:2005
Medical laboratories -- Guidance on laboratory implementation of ISO 15189: 2003
60.60
ISO 22870:2006 [Withdrawn]
Point-of-care testing (POCT) -- Requirements for quality and competence
95.99
ISO 22870:2016
Point-of-care testing (POCT) -- Requirements for quality and competence
60.60
ISO 23640:2011
In vitro diagnostic medical devices -- Evaluation of stability of in vitro diagnostic reagents
90.60
ISO/NP 35001 [Under development]
Laboratory biorisk management system -- Requirements
10.99

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