Standardization · SIS/TK 331

Medicinsk diagnostik

Laboratoriemedicin och medicinsk bilddiagnostik stödjer hälso- och sjukvården genom tillförlitlig diagnostik, hälsokontroller och behandlingsuppföljning. Den tekniska kommittén arbetar med standardisering inom laboratoriemedicin, IVD-produkter, medicinsk bilddiagnostik och biobanker.

Den tekniska kommittén för medicinsk diagnostik utvecklar standarder för säkra och effektiva system, arbetsrutiner och produkter inom laboratoriemedicin, medicinsk bilddiagnostik och in vitro-diagnostik. Arbetet stärker patientsäkerheten genom mer tillförlitliga analyser och undersökningar samt bidrar till en bättre arbetsmiljö. Standarderna används av tillverkare för att uppfylla kraven i IVDR (EU) 2017/746 och riktar sig även till kliniska laboratorier, biobanker, medicinsk bilddiagnostik och patientnära analyser. 

 

Inom TK 331 finns även två arbetgrupper:

 

Bioteknologi och biobanker - AG 05
Denna arbetsgrupp arbetar främst med standardisering inom Biobanker och bioteknologi som pågår inom ISO/TC 276 Biotechnology

 

Medicinsk bilddiagnostik - AG 6

Denna arbetsgrupp deltar i standardiseringsarbetet som pågår inom CEN/TC 470 Quality in medical imaging along the patient pathway.

 

 

More information about the committèes work:

Published 69 standards
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SS-EN 18167:2026
Quality along the patient pathway in medical imaging
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SS-EN ISO 22367:2026
Medical laboratories — Application of risk management to medical laboratories (ISO 22367:2026, IDT)
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SS-EN ISO 18704:2026
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for urine and other body fluids — Isolated cell free DNA (ISO 18704:2026, IDT)
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SS-EN ISO 5649:2025
Medical laboratories — Concepts and specifications for the design, development, idesign, developmentmplementation, and use of laboratory-developed tests (ISO 5649:2024, IDT)
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SS-EN ISO 18113-3:2024
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2022, IDT)
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SS-EN ISO 18113-4:2024
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022, IDT)
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SS-EN ISO 18113-2:2024
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022, IDT)
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SS-EN ISO 18113-1:2024
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022, IDT)
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SS-EN ISO 18113-5:2024
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022, IDT)
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SS-ISO 35001:2019/Amd 1:2024
Biorisk management for laboratories and other related organisations — Amendment 1: Climate action changes (ISO 35001:2019/Amd 1:2024, IDT)
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SS-EN ISO 20916:2024
In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice (ISO 20916:2019, IDT)
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SS-ISO 35001:2019/Amd 1:2024
Biorisk management for laboratories and other related organisations — Amendment 1: Climate action changes (ISO 35001:2019/Amd 1:2024, IDT)
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SS-EN ISO 15189:2022/A11:2024
Medical laboratories - Requirements for quality and competence
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SS-EN ISO 15189:2022/A11:2024
Medical laboratories — Requirements for quality and competence (ISO 15189:2022)
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SS-ISO 20658:2023
Requirements for the collection and transport of samples for medical laboratory examinations (ISO 20658:2023, IDT)
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SS-EN ISO 15189:2022
Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
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SS-EN ISO 15189:2022
Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
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SS-ISO 17593:2022
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)
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SS-EN ISO 20776-2:2022
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 reference broth micro-dilution (ISO 20776-2:2021)
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SS-EN ISO 4307:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)
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SS-EN ISO 16256:2021
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)
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SS-EN ISO 6717:2021
In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)
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SS-EN ISO 20166-4:2021
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)
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SS-EN ISO 23162:2021
Basic semen examination - Specification and test methods (ISO 23162:2021)
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SS-EN ISO 23162:2021
Basic semen examination - Specification and test methods (ISO 23162:2021)
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SIS-ISO/TR 22758:2021
Biotechnology - Biobanking - Implementation guide for ISO 20387 (ISO/TR 22758:2020)
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SS-EN ISO 23118:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma (ISO 23118:2021)
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SS-EN ISO 17511:2021
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)
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SS-EN ISO 20184-3:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA (ISO 20184-3:2021)
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SS-ISO 21151:2020
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)
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SS-EN ISO 20776-1:2020
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)
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SIS-ISO/TS 22583:2020
Guidance for supervisors and operators of point-of-care testing (POCT) devices (ISO/TS 22583:2019)
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SIS-ISO/TS 22583:2020
Guidance for supervisors and operators of point-of-care testing (POCT) devices (ISO/TS 22583:2019)
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SS-EN ISO 22367:2020
Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020)
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SIS-CEN/TS 17390-1:2020
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 1: Isolated RNA
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SIS-CEN/TS 17390-3:2020
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
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SIS-CEN/TS 17390-2:2020
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 2: Isolated DNA
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SS-ISO 35001:2020
Biorisk management for laboratories and other related organisations (ISO 35001:2019, IDT)
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SS-ISO 35001:2020
Biorisk management for laboratories and other related organisations (ISO 35001:2019, IDT)
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SS-EN ISO 20186-3:2019
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)
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SS-EN ISO 20186-1:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019)
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SS-EN ISO 20186-2:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated cellular RNA (ISO 20186-2:2019)
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SS-EN ISO 15195:2019
Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)
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SS-EN ISO 20166-3:2019
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)
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standard ikon pdf
SS-EN ISO 20166-1:2019
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)
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standard ikon pdf
SS-EN ISO 20166-2:2019
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)
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SS-EN ISO 20184-1:2019
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA (ISO 20184-1:2018)
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SS-EN ISO 20184-2:2018
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins (ISO 20184-2:2018)
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SIS-ISO/TS 20658:2017
Medical laboratories - Requirements for collection, transport, receipt, and handling of samples
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SS-EN ISO 6710:2017
Single-use containers for human venous blood specimen collection (ISO 6710:2017)
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SS-EN 13612/AC:2016
Performance evaluation of in vitro diagnostic medical devices
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SS-EN ISO 15197:2016
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
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SIS-CEN/TS 16835-3:2015
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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SIS-CEN/TS 16835-2:2015
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA
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SIS-CEN/TS 16835-1:2015
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA
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SS-EN ISO 23640:2015
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
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SS-EN ISO 19001:2013
In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013)
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SIS-CEN ISO/TS 22367:2010
Medical laboratories - Reduction of error through risk management and continual improvement (ISO/TS 22367:2008, including Cor 1:2009)
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SS-EN ISO 15194:2009
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)
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SS-EN ISO 15193:2009
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)
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SS-EN ISO 18153:2004
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)
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SS-EN 14136:2004
Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
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SS-EN 13975
Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
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SS-EN 13532
General requirements for in vitro diagnostic medical devices for self-testing
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SS-EN 13641
Elimination or reduction of risk of infection related to in vitro diagnostic reagents
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SS-EN 13612
Performance evaluation of in vitro diagnostic medical devices
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SS-EN 12322/A1
In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
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SS-EN 12322
In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
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SS-EN 1659
In vitro diagnostic systems - Culture media for microbiology - Terms and definitions
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Working group 2 workgroups
SIS/TK 331/AG 05, Bioteknologi och Biobanker
SIS/TK 331/AG 06, Medicinsk bildbehandling
Participants 11 companies and organizations
Biobank Sverige, Uppsala
Region Gävleborg, Gävle
Region Kalmar län, Kalmar
Region Kronoberg, Växjö
Region Västerbotten, Umeå
Region Västmanland, Västerås
RISE Research Institutes of Sweden AB, Borås
Styrelsen för ackreditering & teknisk ko, Borås
SYNLAB Sverige AB, Täby
Vårdförbundet, Stockholm
Västra Götalandsregionen, Trollhättan
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International participation 13 international committees
ISO/TC 212, Medical laboratories and in vitro diagnostic systems
ISO/TC 212/WG 1, Quality and competence in the medical laboratory
ISO/TC 212/WG 2, Reference systems
ISO/TC 212/WG 3, In vitro diagnostic products
ISO/TC 212/WG 4, Microbiology and molecular diagnostics
ISO/TC 212/WG 5, Laboratory biorisk management
CEN/TC 140, In vitro diagnostic medical devices
CEN/TC 140/WG 11, Annex Z in CEN/TC 140
CEN/TC 140/WG 3, Quality management in the medical laboratory
SIS/TK 331/AG 05, Bioteknologi och Biobanker:

ISO/TC 276, Biotechnology

ISO/TC 276/WG 2, Biobanks and bioresources

SIS/TK 331/AG 06, Medicinsk bildbehandling:

CEN/TC 470, Quality along the patient pathway in medical imaging

CEN/TC 470/WG 1, Quality along the patient pathway in medical imaging

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Subjects

Health care technology (11) Laboratory medicine (11.100) In vitro diagnostic test systems (11.100.10) Other (11.100.99)

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Contact

If you have questions or want to know more about the SIS standardization activities? Please contact us.

Hanna Dumky
Project manager
hanna.dumky@sis.se

Mattis Rundgren
Project coordinator
mattis.rundgren@sis.se

Linda Lindh
Chairman
Region Gävleborg