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Standard and/or project under the direct responsibility of ISO/TC 212 Secretariat | Stage | ICS |
---|---|---|
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated human DNA
|
60.60 | |
Competence requirements for biorisk management advisors
|
60.60 | |
Medical laboratories — Concepts and specifications for the design, development, implementation and use of laboratory-developed tests
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50.20 | |
In vitro diagnostic test systems — Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods
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60.60 | |
ISO 35001 — Biorisk management for laboratories and other related organisations — Implementation guidance
|
20.00 |
|
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood — Part 1: Isolated RNA
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60.00 | |
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood — Part 2: Isolated DNA
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60.00 | |
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
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60.00 | |
Sequencing and clinical application to infectious diseases
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20.00 |
|
Medical laboratories — Particular requirements for quality and competence
|
95.99 | |
Medical laboratories — Particular requirements for quality and competence
|
95.99 | |
Medical laboratories — Requirements for quality and competence
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95.99 | |
Medical laboratories — Requirements for quality and competence
|
60.60 | |
Medical laboratories — Requirements for safety
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95.99 | |
Medical laboratories — Requirements for safety
|
60.60 | |
In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Presentation of reference measurement procedures
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95.99 | |
In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for content and presentation of reference measurement procedures
|
90.92 | |
In vitro diagnostic medical devices — Requirements for reference measurement procedures
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50.00 | |
In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Description of reference materials
|
95.99 | |
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 | |
In vitro diagnostic medical devices — Requirements for certified reference materials and the content of supporting documentation
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50.00 | |
Laboratory medicine — Requirements for reference measurement laboratories
|
95.99 | |
Laboratory medicine — Requirements for the competence of calibration laboratories using reference measurement procedures
|
90.93 | |
In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
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95.99 | |
In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
|
90.60 | |
Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
|
90.60 | |
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 | |
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 | |
Manufacturers’ considerations for in vitro diagnostic medical devices in a public health emergency
|
50.20 | |
Clinical laboratory testing — Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
|
90.60 | |
In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values assigned to calibrators and control materials
|
95.99 | |
In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
|
60.60 | |
Medical laboratories — Reagents for staining biological material — Guidance for users
|
90.93 | |
Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
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95.99 | |
Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
|
60.60 | |
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
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95.99 | |
In vitro diagnostic test systems — Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens — Laboratory quality practice guide
|
60.60 | |
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
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95.99 | |
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
|
95.99 | |
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements
|
60.60 | |
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
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95.99 | |
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
|
60.60 | |
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
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95.99 | |
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
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60.60 | |
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
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95.99 | |
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
|
60.60 | |
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
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95.99 | |
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
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60.60 | |
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 | |
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for urine and other body fluids — Isolated cell free DNA
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40.00 | |
In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
|
95.99 | |
In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
|
90.93 | |
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 1: Isolated RNA
|
90.60 | |
Molecular in vitro diagnostic examinations — Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 2: Isolated proteins
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90.60 | |
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 3: Isolated DNA
|
90.60 | |
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 | |
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 1: Isolated RNA
|
90.60 | |
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 2: Isolated proteins
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90.60 | |
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 3: Isolated DNA
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60.60 | |
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNA
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90.60 | |
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA
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90.60 | |
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma
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90.20 | |
Requirements for the collection and transport of samples for medical laboratory examinations
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60.60 | |
Medical laboratories — Requirements for collection, transport, receipt, and handling of samples
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95.99 | |
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
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95.99 | |
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
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90.60 | |
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
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95.99 | |
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 against reference broth micro-dilution
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60.60 | |
Medical laboratories — Practical guidance for the estimation of measurement uncertainty
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90.93 | |
In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
|
90.60 | |
In vitro diagnostic medical devices — Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples
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60.60 | |
In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluation
|
60.60 | |
In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification
|
60.60 | |
In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 3: Interpretation and reports
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50.20 | |
Medical laboratories — Application of risk management to medical laboratories
|
90.92 | |
Medical laboratories — Reduction of error through risk management and continual improvement
|
95.99 | |
Medical laboratories — Reduction of error through risk management and continual improvement — Technical Corrigendum 1
|
95.99 | |
Medical laboratories — Application of risk management to medical laboratories
|
30.60 |
|
Guidance for supervisors and operators of point-of-care testing (POCT) devices
|
95.99 | |
Requirements and recommendations for supervisors and operators of point-of-care testing (POCT) equipment
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60.60 | |
Medical laboratories — Guidance on laboratory implementation of ISO 15189: 2003
|
95.99 | |
Point-of-care testing (POCT) — Requirements for quality and competence
|
95.99 | |
Point-of-care testing (POCT) — Requirements for quality and competence
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95.99 | |
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma
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60.60 | |
Basic semen examination — Specification and test methods
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60.60 | |
In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
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90.92 | |
In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
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30.20 |
|
Medical laboratories — Guidance on application of ISO 15189 in anatomic pathology
|
60.60 | |
Medical laboratories — Part 1: General principles for the application of artificial intelligence in medical laboratories
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20.00 |
|
Medical laboratories — Part 2: Digital pathology and artificial intelligence (AI)-based image analysis
|
20.00 |
|
Lateral flow immunoassay for rapid diagnostic testing — General guidance for manufacturers
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20.00 |
|
Electronic Instructions for Use for In Vitro Diagnostic Medical Devices (Minimum required information and means of delivery)
|
30.20 |
|
Biorisk management for laboratories and other related organisations
|
90.20 | |
Biorisk management for laboratories and other related organisations — Amendment 1: Climate action changes
|
60.60 |
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