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Standard and/or project under the direct responsibility of ISO/TC 212 Secretariat Stage ICS
ISO 15189:2003
Medical laboratories — Particular requirements for quality and competence
95.99
ISO 15189:2007
Medical laboratories — Particular requirements for quality and competence
95.99
ISO 15189:2012
Medical laboratories — Requirements for quality and competence
90.92
ISO/AWI 15189
Medical laboratories — Requirements for quality and competence
20.00
ISO 15190:2003
Medical laboratories — Requirements for safety
90.92
ISO/FDIS 15190
Medical laboratories — Requirements for safety
50.20
ISO 15193:2002
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
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
95.99
ISO 15195:2018
Laboratory medicine — Requirements for the competence of calibration laboratories using reference measurement procedures
60.60
ISO 15197:2003
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
90.93
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
90.92
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/TS 16782:2016
Clinical laboratory testing — Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
90.20
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/FDIS 17511
In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
50.20
ISO/TS 17518:2015
Medical laboratories — Reagents for staining biological material — Guidance for users
90.93
ISO 17593:2007
Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
90.92
ISO/CD 17593
Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
30.60
ISO/DIS 17822-2
In vitro diagnostic test systems — Nucleic acid amplification- based examination procedures for detection and identification of microbial pathogens — Part 2: Laboratory quality practice guide
40.20
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
90.93
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 18113-1:2009
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
90.92
ISO 18113-2:2009
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
90.92
ISO 18113-3:2009
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
90.92
ISO 18113-4:2009
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
90.92
ISO 18113-5:2009
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
90.92
ISO/AWI 18113-1
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
10.99
ISO/AWI 18113-2
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
10.99
ISO/AWI 18113-3
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
10.99
ISO/AWI 18113-4
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
10.99
ISO/AWI 18113-5
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
10.99
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 19001:2002
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
90.93
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 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 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/AWI 20166-4
Molecular in vitro diagnostic examinations — Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 4: in situ detection techniques
20.00
ISO 20184-1:2018
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 1: Isolated RNA
60.60
ISO 20184-2:2018
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 2: Isolated proteins
60.60
ISO/NP 20184-3
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 3: Isolated DNA
10.99
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 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 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/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
95.99
ISO 20776-1:2019
Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases
60.60
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
90.92
ISO/NP 20776-2
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
10.99
ISO/TS 20914:2019
Medical laboratories — Practical guidance for the estimation of measurement uncertainty
60.60
ISO 20916:2019
In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
60.60
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/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
40.60
ISO/NP 21474-2
In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Part 2 — Validation and Verification
10.99
ISO/FDIS 22367
Medical laboratories — Application of risk management to medical laboratories
50.20
ISO/TS 22367:2008
Medical laboratories — Reduction of error through risk management and continual improvement
90.92
ISO/TS 22367:2008/Cor 1:2009
Medical laboratories — Reduction of error through risk management and continual improvement — Technical Corrigendum 1
60.60
ISO/TS 22583
Guidance for supervisors and operators of point-of-care testing (POCT) devices
60.00
ISO/TR 22869:2005
Medical laboratories — Guidance on laboratory implementation of ISO 15189: 2003
95.99
ISO 22870:2006
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/CD 23118
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for metabolomics in urine, venous blood serum and plasma
30.20
ISO/AWI 23162
Basic semen analysis — Specification and test methods
20.00
ISO 23640:2011
In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
90.93
ISO 35001:2019
Biorisk management for laboratories and other related organisations
60.60

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