Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated human DNA

Competence requirements for biorisk management advisors

Medical laboratories — Concepts and specifications for the design, development, implementation and use of laboratory-developed tests

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

Implementation guidance for biorisk management for laboratories and other related organizations

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood — Part 1: Isolated RNA

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood — Part 2: Isolated DNA

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

Sequencing and clinical application to infectious diseases

Medical laboratories — Particular requirements for quality and competence

Medical laboratories — Particular requirements for quality and competence

Medical laboratories — Requirements for quality and competence

Medical laboratories — Requirements for quality and competence

Medical laboratories — Requirements for safety

Medical laboratories — Requirements for safety

Medical laboratories — Requirements for safety

In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Presentation of reference measurement procedures

In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for content and presentation of reference measurement procedures

In vitro diagnostic medical devices — Requirements for reference measurement procedures

In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Description of reference materials

In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for certified reference materials and the content of supporting documentation

In vitro diagnostic medical devices — Requirements for certified reference materials and the content of supporting documentation

Laboratory medicine — Requirements for reference measurement laboratories

Laboratory medicine — Requirements for the competence of calibration laboratories using reference measurement procedures

Laboratory medicine — Requirements for the competence of calibration laboratories using reference measurement procedures — Amendment 1

In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer

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

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

Manufacturers’ considerations for in vitro diagnostic medical devices in a public health emergency

Clinical laboratory testing — Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing

Clinical laboratory testing — Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing

In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values assigned to calibrators and control materials

In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples

Medical laboratories — Reagents for staining biological material — Guidance for users

Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

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

In vitro diagnostic test systems — Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens — Laboratory quality practice guide

Guidance on the validation and verification of quantitative and qualitative methods

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

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing

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

Molecular in vitro diagnostic examinations — Requirements and recommendations for pre-examination processes for urine and other body fluids — Isolated cell-free DNA

In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 1: Isolated RNA

Molecular in vitro diagnostic examinations — Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 2: Isolated proteins

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 3: Isolated DNA

Molecular in vitro diagnostic examinations — Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 4: In situ detection techniques

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 1: Isolated RNA

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 2: Isolated proteins

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 3: Isolated DNA

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNA

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma

Requirements for the collection and transport of samples for medical laboratory examinations

Medical laboratories — Requirements for collection, transport, receipt, and handling of samples

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

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

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

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

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

ISO/TS 20776-3, Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — — Part 3: Part 3: Quality performance of disc-diffusion agar method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases

Medical laboratories — Practical guidance for the estimation of measurement uncertainty

In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice

In vitro diagnostic medical devices — Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples

Guidance for the implementation of emerging technology in medical laboratories

In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluation

In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification

In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 3: Interpretation and reports

In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 4: Detection of pathogens

Medical laboratories — Application of risk management to medical laboratories

Medical laboratories — Reduction of error through risk management and continual improvement

Medical laboratories — Reduction of error through risk management and continual improvement — Technical Corrigendum 1

Medical laboratories — Application of risk management to medical laboratories

Guidance for supervisors and operators of point-of-care testing (POCT) devices

Requirements and recommendations for supervisors and operators of point-of-care testing (POCT) equipment

Medical laboratories — Guidance on laboratory implementation of ISO 15189: 2003

Point-of-care testing (POCT) — Requirements for quality and competence

Point-of-care testing (POCT) — Requirements for quality and competence

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma

Basic semen examination — Specification and test methods

In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents

In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents

Medical laboratories — Guidance on application of ISO 15189 in anatomic pathology

Medical laboratories — Part 1: General principles for the application of artificial intelligence in medical laboratories

Medical laboratories — Part 2: Digital pathology and artificial intelligence (AI)-based image analysis

Medical laboratories — Guidance for personnel competence and development

In Vitro Diagnostic Medical Devices: Lateral Flow Immunoassay for Rapid Diagnostic Testing– General Guidance for Manufacturers

Electronic instructions for use for in vitro diagnostic medical devices — Minimum required information and means of delivery

In vitro diagnostic Next Generation Sequencing (NGS) workflows — Part 1: Human DNA examination

In vitro diagnostic Next Generation Sequencing (NGS) workflows — Part 2: Human RNA examination

In vitro diagnostic medical devices — Requirements for determining commutability of certified reference materials used as secondary calibrators or trueness controls

In vitro diagnostic medical devices — Definition of analytical performance specifications for laboratory measurements based on medical requirements

Design and workflow requirements for in vitro diagnostics NGS based oncology application

In vitro diagnostic medical devices — Performance evaluation — Requirements and guidance

Biorisk management for laboratories and other related organisations

Biorisk management for laboratories and other related organisations — Amendment 1: Climate action changes

Biorisk management for laboratories and other related organisations