Document Center List of Standards on In Vitro Diagnostic Test Systems
ICS Code 11.100.10
Return to ICS Index.Up to Level 2:
The following documents are a part of this series:
ASTM:
- ASTM-F2721 - Standard Guide for Pre-clinical
in vivo Evaluation in Critical Size Segmental Bone Defects - ASTM-F2944 - Standard Practice for Automated Colony Forming Unit (CFU) Assays—Image Acquisition and Analysis Method for Enumerating and Characterizing Cells and Colonies in Culture
- ASTM-F3142 - Standard Guide for Evaluation of
in vitro Release of Biomolecules from Biomaterials Scaffolds for TEMPs
BSI:
- BS-EN-12286 - In Vitro Diagnostic Medical Devices, Measurement of Quantities in Samples of Biologica
- BS-EN-12376 - In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
- BS-EN-13640 - Stability testing of in vitro diagnostic reagents
- BS-EN-1658 - Requirements for marking of in vitro diagnostic instruments
- BS-EN-IEC-61326-2-6-TC - Tracked Changes. Electrical equipment for measurement, control and laboratory use. EMC requirements
- BS-EN-ISO-13079 - Laboratory glass and plastics ware. Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method
- BS-EN-ISO-15193 - In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for content and presentation of reference measurement procedures
- BS-EN-ISO-15194 - In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for certified reference materials and the content of supporting documentation
- BS-EN-ISO-15197 - In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
- BS-EN-ISO-15197-TC - Tracked Changes. In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
- BS-EN-ISO-16256 - 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
- BS-EN-ISO-16256-TC - Tracked Changes. 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
- BS-EN-ISO-17511-TC - Tracked Changes. In vitro diagnostic medical devices. Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
- BS-EN-ISO-18113-1 - In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling)
- BS-EN-ISO-18113-2 - In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling)
- BS-EN-ISO-18113-3 - In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling)
- BS-EN-ISO-18113-4 - In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling)
- BS-EN-ISO-18113-5 - In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling)
- BS-EN-ISO-19001 - In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
- BS-EN-ISO-20166-1 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue
- BS-EN-ISO-20166-2 - Molecular in vitro diagnostic examinations. Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue
- BS-EN-ISO-20166-3 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue
- BS-EN-ISO-20166-4 - Molecular in vitro diagnostic examinations. Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue
- BS-EN-ISO-20184-1 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue
- BS-EN-ISO-20184-2 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue
- BS-EN-ISO-20184-3-TC - Tracked Changes. Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue
- BS-EN-ISO-20186-1 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood
- BS-EN-ISO-20186-2 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood
- BS-EN-ISO-20186-3 - Molecular in-vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood
- BS-EN-ISO-23118-TC - Tracked Changes. Molecular in vitro diagnostic examinations. Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma
- BS-EN-ISO-23640 - In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
- BS-EN-ISO-4307 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA
- BS-EN-ISO-4307-TC - Tracked Changes. Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA
- BS-EN-ISO-6717 - In vitro diagnostic medical devices. Single-use containers for the collection of specimens from humans other than blood
- BS-EN-ISO-6717-TC - Tracked Changes. In vitro diagnostic medical devices. Single-use containers for the collection of specimens from humans other than blood
- BS-ISO-17593 - Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
- BS-ISO-17593-TC - Tracked Changes. Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
- BS-ISO-18113-1 - Part 1: Terms, Definitions & General Requirements, Clinical Laboratory Testing & in V
- BS-ISO-18113-2 - Part 2: in Vitro Diagnostic Reagents for Professional Use, Clinidcal Laboratory Testin
- BS-ISO-18113-3 - Part 3: in Vitro Diagnostic Instruments for Professional Use, Clinical Laboratory Test
- BS-ISO-18113-4 - Part 4: in Vitro Diagnostic Reagents for Self-Testing, Clinical Laboratory Testing & I
- BS-ISO-18113-5 - Part 5: in Vitro Diagnostic Instruments for Self-Testing, Clinical Laboratory Testing
- BS-ISO-20916 - In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice
- BS-ISO-21151 - In vitro diagnostic medical devices. Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples
- BS-ISO-21474-1 - In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids
- BS-ISO-21474-2 - In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids
- PD-CEN-16826-1 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for snap frozen tissue
- PD-CEN-16826-2 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for snap frozen tissue
- PD-CEN-16826-3 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for snap frozen tissue
- PD-CEN-16827-1 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for FFPE tissue
- PD-CEN-16827-2 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for FFPE tissue
- PD-CEN-16827-3 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for FFPE tissue
- PD-CEN-16835-1 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood
- PD-CEN-16945 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for metabolomics in urine, venous blood serum and plasma
- PD-CEN-17305 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA
- PD-CEN-17390-1 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood
- PD-CEN-17390-2 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood
- PD-CEN-17390-3 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood
- PD-CEN-17742 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated circulating cell free RNA from plasma
- PD-CEN-17747 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood. DNA, RNA and proteins
- PD-CEN-17811 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for urine and other body fluids. Isolated cell free DNA
- PD-CEN-17981-1 - In vitro diagnostic Next Generation Sequencing (NGS) workflows
- PD-CEN-17981-2 - In vitro diagnostic Next Generation Sequencing (NGS) workflows
ISO:
- ISO-12480-3 - Cranes - Safe use - Part 3: Tower cranes
- ISO-13079 - Laboratory glass and plastics ware - Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method
- ISO-15193 - In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
- ISO-15194 - In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation
- ISO-15197 - In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
- ISO-15198 - Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
- ISO-16256 - 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
- ISO-17511 - In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
- ISO-18112 - 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
- ISO-18113-1 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements
- ISO-18113-2 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
- ISO-18113-3 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use
- ISO-18113-4 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
- ISO-18113-5 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
- ISO-18153 - 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
- ISO-19001 - In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
- ISO-20166-1 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 1: Isolated RNA
- ISO-20166-2 - Molecular in vitro diagnostic examinations - Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 2: Isolated proteins
- ISO-20166-3 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA
- ISO-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
- ISO-20184-1 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA
- ISO-20184-2 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins
- ISO-20184-3 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA
- ISO-20186-1 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA
- ISO-20186-3 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma
- ISO-20916 - In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice
- ISO-21151 - In vitro diagnostic medical devices - Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples
- ISO-21474-1 - In vitro diagnostic medical devices - Multiplex molecular testing for nucleic acids - Part 1: Terminology and general requirements for nucleic acid quality evaluation
- ISO-21474-2 - In vitro diagnostic medical devices - Multiplex molecular testing for nucleic acids - Part 2: Validation and verification
- ISO-23118 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma
- ISO-23640 - In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
- ISO-29701 - Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test
- ISO-4307 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA
- ISO-6717 - In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood
Other SDOs:
- 2011/100/EU - Commission Directive 2011/100/EU of 20 December 2011 amending Directive 98/79/EC of the European Parliament and of the Council on in-vitro diagnostic medical devices Text with EEA relevance
- DIN-EN-ISO-20776-1 - Part 1: Reference Method for Testing the In-Vitro Activity of Antimicrobial Agents AGA
- DIN-EN-ISO-22870 - Point-of-care testing (POCT) - Requirements for quality and competence
- DIN-EN-ISO-29701 - Nanotechnologies. Endotoxin Test on Nanomaterial Samples for in Vitro Systems. Limulus Amebocyte Lysate (Lal) Test
- EN-ISO-13079 - Laboratory glass and plastics ware - Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method (ISO 13079:2011)
- EN-ISO-15193 - In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
- EN-ISO-15194 - In Vitro Diagnostic Medical Devices - Measurement of Quantities in Samples of Biologic
- EN-ISO-15197 - In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
- EN-ISO-16256 - Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases (ISO 16256:2012)
- EN-ISO-18113-1 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
- EN-ISO-18113-2 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
- EN-ISO-18113-3 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use
- EN-ISO-18113-4 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
- EN-ISO-18113-5 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
- EN-ISO-19001 - In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013)
- EN-ISO-20166-3 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA (ISO 20166-3:2018)
- EN-ISO-20186-1 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019)
- EN-ISO-20186-2 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated cellular RNA (ISO 20186-2:2019)
- EN-ISO-23640 - In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
- EN-ISO-29701 - Nanotechnologies. Endotoxin Test on Nanomaterial Samples for in Vitro Systems. Limulus Amebocyte Lysate (Lal) Test
- SIS-CEN-17305 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA
- SIS-CEN-17390-1 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 1: Isolated RNA
- SIS-CEN-17390-2 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 2: Isolated DNA
- SIS-CEN-17390-3 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 3: Preparations for analytical CTC staining
- SIS-CEN-ISO/TS-22367 - Medical laboratories - Reduction of error through risk management and continual improvement (ISO/TS 22367:2008, including Cor 1:2009)
- SIS-CEN/TS-16826-1 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 1: Isolated RNA
- SIS-CEN/TS-16826-2 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 2: Isolated proteins
- SIS-CEN/TS-16827-1 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 1: Isolated RNA
- SIS-CEN/TS-16827-2 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 2: Isolated proteins
- SIS-CEN/TS-16835-1 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA
- SS-EN-12286 - In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures
- SS-EN-12286-AM1 - In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures
- SS-EN-12287 - In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials
- SS-EN-12376 - In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
- SS-EN-13532 - General requirements for in vitro diagnostic medical devices for self-testing
- SS-EN-13612 - Performance evaluation of in vitro diagnostic medical devices
- SS-EN-13640 - Stability testing of in vitro diagnostic reagents
- SS-EN-13641 - Elimination or reduction of risk of infection related to in vitro diagnostic reagents
- SS-EN-13975 - Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
- SS-EN-14136 - Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
- SS-EN-14254 - In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
- SS-EN-1658 - Requirements for marking of in vitro diagnostic instruments
- SS-EN-375 - Information supplied by the manufacturer with in vitro diagnostic reagents for professional use
- SS-EN-376 - Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
- SS-EN-591 - Instructions for use for in vitro diagnostic instruments for professional use
- SS-EN-592 - Instructions for use for in vitro diagnostic instruments for self-testing
- SS-EN-928 - In vitro diagnostic systems - Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices
- SS-EN-ISO-13079 - Laboratory glass and plastics ware - Tubes for the measurement of erythrocyte sedimentation rate by the Westergren method (ISO 13079:2011)
- SS-EN-ISO-15193 - In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)
- SS-EN-ISO-15194 - In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009)
- SS-EN-ISO-15197 - In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
- SS-EN-ISO-16256 - 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 (ISO 16256:2021)
- SS-EN-ISO-17511 - In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)
- SS-EN-ISO-18113-1 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
- SS-EN-ISO-18113-2 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
- SS-EN-ISO-18113-3 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
- SS-EN-ISO-18113-4 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
- SS-EN-ISO-18113-5 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
- SS-EN-ISO-18153 - In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)
- SS-EN-ISO-19001 - In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013)
- SS-EN-ISO-20166-1 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 1: Isolated RNA (ISO 20166-1:2018)
- SS-EN-ISO-20166-2 - Molecular in vitro diagnostic examinations - Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 2: Isolated proteins (ISO 20166-2:2018)
- SS-EN-ISO-20166-3 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA (ISO 20166-3:2018)
- SS-EN-ISO-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 (ISO 20166-4:2021)
- SS-EN-ISO-20184-1 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA (ISO 20184-1:2018)
- SS-EN-ISO-20184-2 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins (ISO 20184-2:2018)
- SS-EN-ISO-20184-3 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA (ISO 20184-3:2021)
- SS-EN-ISO-20186-1 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019)
- SS-EN-ISO-20186-2 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated cellular RNA (ISO 20186-2:2019)
- SS-EN-ISO-20186-3 - Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma (ISO 20186-3:2019)
- SS-EN-ISO-20776-1 - 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 (ISO 20776-1:2019, including Corrected version 2019-12)
- SS-EN-ISO-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 against reference broth micro-dilution (ISO 20776-2:2021)
- SS-EN-ISO-21904-4 - Health and safety in welding and allied processes - Equipment for capture and separation of welding fume - Part 4: Determination of the minimum air volume flow rate of capture devices (ISO 21904-4:2020)
- SS-EN-ISO-22367 - Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020)
- SS-EN-ISO-22870 - Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016)
- SS-EN-ISO-23118 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma (ISO 23118:2021)
- SS-EN-ISO-23640 - In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
- SS-EN-ISO-29701 - Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test (ISO 29701:2010)
- SS-EN-ISO-4307 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)
- SS-EN-ISO-6717 - In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)
- SS-ISO-17593 - Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy (ISO 17593:2022, IDT)
- SS-ISO-21151 - In vitro diagnostic medical devices - Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples (ISO 21151:2020, IDT)