TABLE 5.
European Committee for Standardization Technical Committee (CEN/TC) 140 in vitro diagnostic medical devices published standards. All projects are sorted by date and available at https://www.spidia.eu/projects/standard-documents (Accessed 28 July 2022).
| References | Date | Title |
|---|---|---|
| CEN/TS 17811:2022 | 22 June 2022 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA |
| CEN/TS 17747:2022 | 20 April 2022 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins |
| CEN/TS 17742:2022 | 30 March 2022 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma |
| EN ISO 20776-2:2022 | 19 January 2022 | 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 References broth micro-dilution (ISO 20776-2:2021) |
| CEN/TS 17688-2:2021 | 22 December 2021 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 2: Isolated proteins |
| CEN/TS 17688-1:2021 | 22 December 2021 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 1: Isolated cellular RNA |
| CEN/TS 17688-3:2021 | 22 December 2021 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 3: Isolated genomic DNA |
| EN ISO 4307:2021 | 3 November 2021 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021) |
| EN ISO 16256:2021 | 27 October 2021 | Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution References method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases (ISO 16256:2021) |
| EN ISO 6717:2021 | 8 September 2021 | In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021) |
| EN ISO 20166-4:2021 | 28 July 2021 | 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) |
| EN ISO 23162:2021 | 14 July 2021 | Basic semen examination - Specification and test methods (ISO 23162:2021) |
| EN ISO 17511:2021 | 2 June 2021 | In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020) |
| EN ISO 23118:2021 | 2 June 2021 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma (ISO 23118:2021) |
| EN ISO 20184-3:2021 | 26 May 2021 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA (ISO 20184-3:2021) |
| CEN/TS 17626:2021 | 5 May 2021 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA |
| EN ISO 20776-1:2020 | 1 July 2020 | Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Broth micro-dilution References 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) |
| EN ISO 22367:2020 | 11 March 2020 | Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020) |
| CEN/TS 17390-1:2020 | 22 January 2020 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 1: Isolated RNA |
| CEN/TS 17390-2:2020 | 22 January 2020 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 2: Isolated DNA |
| CEN/TS 17390-3:2020 | 22 January 2020 | 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 |
| EN ISO 20186-3:2019 | 23 October 2019 | 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) |
| EN ISO 20186-1:2019 | 27 March 2019 | 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 20186-2:2019 | 27 March 2019 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA (ISO 20186-2:2019) |
| EN ISO 15195:2019 | 6 February 2019 | Laboratory medicine - Requirements for the competence of calibration laboratories using References measurement procedures (ISO 15195:2018) |
| EN ISO 20166-3:2019 | 23 January 2019 | 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 20166-2:2018 | 19 December 2018 | 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) |
| EN ISO 20166-1:2018 | 19 December 2018 | 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) |
| EN ISO 20184-1:2018 | 19 December 2018 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA (ISO 20184-1:2018) |
| EN ISO 20184-2:2018 | 12 December 2018 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins (ISO 20184-2:2018) |
| EN ISO 6710:2017 | 6 September 2017 | Single-use containers for human venous blood specimen collection (ISO 6710:2017) |
| EN ISO 22870:2016 | 30 November 2016 | Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016) |
| EN ISO 15197:2015 | 10 June 2015 | In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013) |
| EN ISO 23640:2015 | 10 June 2015 | In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011) |
| EN ISO 19001:2013 | 20 March 2013 | In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013) |
| EN ISO 15189:2012 | 1 November 2012 | Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15) |
| EN ISO 18113-5:2011 | 19 October 2011 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009) |
| EN ISO 18113-2:2011 | 19 October 2011 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009) |
| EN ISO 18113-3:2011 | 19 October 2011 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009) |
| EN ISO 18113-4:2011 | 19 October 2011 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009) |
| EN ISO 18113-1:2011 | 19 October 2011 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
| EN ISO 15193:2009 | 1 May 2009 | In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of References measurement procedures (ISO 15193:2009) |
| EN ISO 15194:2009 | 1 May 2009 | In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified References materials and the content of supporting documentation (ISO 15194:2009) |
| EN 14136:2004 | 19 May 2004 | Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures |
| EN ISO 18153:2003 | 15 August 2003 | 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) |
| EN 13975:2003 | 19 March 2003 | Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects |
| EN 13612:2002/AC:2002 | 18 December 2002 | Performance evaluation of in vitro diagnostic medical devices |
| EN 13641:2002 | 8 May 2002 | Elimination or reduction of risk of infection related to in vitro diagnostic reagents |
| EN 13532:2002 | 17 April 2002 | General requirements for in vitro diagnostic medical devices for self-testing |
| EN 13612:2002 | 20 March 2002 | Performance evaluation of in vitro diagnostic medical devices |
| EN 12322:1999/A1:2001 | 24 October 2001 | In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media |
| EN 12322:1999 | 21 April 1999 | In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media |
| EN 1659:1996 | 20 November 1996 | In vitro diagnostic systems - Culture media for microbiology - Terms and definitions |