About CEN
The European Committee for Standardization is one of three European Standardization Organizations (together with CENELEC and ETSI) that have been officially recognized by the European Union and by the European Free Trade Association (EFTA) as being responsible for developing and defining voluntary standards at European level.
CEN/TC 140 |
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In vitro diagnostic medical devices |
CEN/TC 140 Published Standards
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CEN ISO/TS 5798:2022
(WI=00140152) 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 (ISO/TS 5798:2022) |
2022-11-30 |
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CEN/TS 17390-1:2020
(WI=00140123) Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 1: Isolated RNA |
2020-01-22 |
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CEN/TS 17390-2:2020
(WI=00140125) Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 2: Isolated DNA |
2020-01-22 |
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CEN/TS 17390-3:2020
(WI=00140124) 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 |
2020-01-22 |
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CEN/TS 17626:2021
(WI=00140127) Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA |
2021-05-05 |
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CEN/TS 17688-1:2021
(WI=00140128) Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 1: Isolated cellular RNA |
2021-12-22 |
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CEN/TS 17688-2:2021
(WI=00140126) Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 2: Isolated proteins |
2021-12-22 |
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CEN/TS 17688-3:2021
(WI=00140129) Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 3: Isolated genomic DNA |
2021-12-22 |
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CEN/TS 17742:2022
(WI=00140134) Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma |
2022-03-30 |
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CEN/TS 17747:2022
(WI=00140133) Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins |
2022-04-20 |
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CEN/TS 17811:2022
(WI=00140130) Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA |
2022-06-22 |
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CEN/TS 17981-1:2023
(WI=00140151) In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 1: Human DNA examination |
2023-11-29 |
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CEN/TS 17981-2:2023
(WI=00140153) In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 2: Human RNA examination |
2023-11-29 |
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EN 12322:1999
(WI=00140031) In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media |
1999-04-21 |
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EN 12322:1999/A1:2001
(WI=00140050) In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media |
2001-10-24 |
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EN 13532:2002
(WI=00140043) General requirements for in vitro diagnostic medical devices for self-testing |
2002-04-17 |
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EN 13612:2002
(WI=00140037) Performance evaluation of in vitro diagnostic medical devices |
2002-03-20 |
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EN 13612:2002/AC:2002
(WI=00140C01) Performance evaluation of in vitro diagnostic medical devices |
2002-12-18 |
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EN 13641:2002
(WI=00140041) Elimination or reduction of risk of infection related to in vitro diagnostic reagents |
2002-05-08 |
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EN 13975:2003
(WI=00140040) Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects |
2003-03-19 |
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EN 14136:2004
(WI=00140045) Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures |
2004-05-19 |
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EN 1659:1996
(WI=00140024) In vitro diagnostic systems - Culture media for microbiology - Terms and definitions |
1996-11-20 |
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EN ISO 15189:2022
(WI=00140135) Medical laboratories - Requirements for quality and competence (ISO 15189:2022) |
2022-12-14 |
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EN ISO 15189:2022/A11:2023
(WI=00140165) Medical laboratories - Requirements for quality and competence |
2023-11-15 |
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EN ISO 15193:2009
(WI=00140061) 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) |
2009-05-01 |
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EN ISO 15194:2009
(WI=00140062) 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) |
2009-05-01 |
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EN ISO 15195:2019
(WI=00140104) Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018) |
2019-02-06 |
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EN ISO 15197:2015
(WI=00140101) In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013) |
2015-06-10 |
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EN ISO 16256:2021
(WI=00140137) 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) |
2021-10-27 |
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EN ISO 17511:2021
(WI=00140118) In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020) |
2021-06-02 |
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EN ISO 18113-1:2024
(WI=00140141) In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022) |
2024-06-12 |
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EN ISO 18113-2:2024
(WI=00140142) In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022) |
2024-06-12 |
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EN ISO 18113-3:2024
(WI=00140143) In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2022) |
2024-06-12 |
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EN ISO 18113-4:2024
(WI=00140144) In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022) |
2024-06-12 |
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EN ISO 18113-5:2024
(WI=00140145) In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022) |
2024-06-12 |
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EN ISO 18153:2003
(WI=00140044) 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) |
2003-08-15 |
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EN ISO 19001:2013
(WI=00140078) In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013) |
2013-03-20 |
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EN ISO 20166-1:2018
(WI=00140111) 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) |
2018-12-19 |
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EN ISO 20166-2:2018
(WI=00140108) 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) |
2018-12-19 |
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EN ISO 20166-3:2019
(WI=00140109) 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) |
2019-01-23 |
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EN ISO 20166-4:2021
(WI=00140136) 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) |
2021-07-28 |
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EN ISO 20184-1:2018
(WI=00140112) Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA (ISO 20184-1:2018) |
2018-12-19 |
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EN ISO 20184-2:2018
(WI=00140113) Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins (ISO 20184-2:2018) |
2018-12-12 |
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EN ISO 20184-3:2021
(WI=00140139) Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA (ISO 20184-3:2021) |
2021-05-26 |
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EN ISO 20186-1:2019
(WI=00140105) Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019) |
2019-03-27 |
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EN ISO 20186-2:2019
(WI=00140107) Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA (ISO 20186-2:2019) |
2019-03-27 |
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EN ISO 20186-3:2019
(WI=00140106) 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) |
2019-10-23 |
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EN ISO 20776-1:2020
(WI=00140114) 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) |
2020-07-01 |
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EN ISO 20776-2:2022
(WI=00140138) 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) |
2022-01-19 |
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EN ISO 20916:2024
(WI=00140146) In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019) |
2024-03-06 |
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EN ISO 22367:2020
(WI=00140120) Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020) |
2020-03-11 |
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EN ISO 23118:2021
(WI=00140132) Molecular in vitro diagnostic examinations - Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma (ISO 23118:2021) |
2021-06-02 |
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EN ISO 23162:2021
(WI=00140131) Basic semen examination - Specification and test methods (ISO 23162:2021) |
2021-07-14 |
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EN ISO 23640:2015
(WI=00140100) In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011) |
2015-06-10 |
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EN ISO 4307:2021
(WI=00140147) Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021) |
2021-11-03 |
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EN ISO 6710:2017
(WI=00140110) Single-use containers for human venous blood specimen collection (ISO 6710:2017) |
2017-09-06 |
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EN ISO 6717:2021
(WI=00140140) In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021) |
2021-09-08 |
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