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Number of results 111
UNE-ISO/TS 5441:2025 EX UNE
Status: Vigente/ 2025-09-24
Competence requirements for biorisk management advisors
UNE-ISO/TS 23824:2025 EX UNE
Medical laboratories — Guidance on application of ISO 15189 in anatomic pathology
UNE-EN ISO 5649:2025 UNE
Medical laboratories - Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests (ISO 5649:2024)
UNE-EN ISO 18113-1:2025 UNE
Status: Current/ 2025-01-22
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022)
UNE-EN ISO 18113-2:2025 UNE
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022)
UNE-EN ISO 18113-3:2025 UNE
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2022)
UNE-EN ISO 18113-4:2025 UNE
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022)
UNE-EN ISO 18113-5:2025 UNE
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022)
UNE-EN ISO 20916:2024 UNE
Status: Vigente/ 2024-11-27
In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
UNE-EN ISO 15189:2023/A11:2024 UNE
Status: Vigente/ 2024-06-19
Medical laboratories - Requirements for quality and competence
UNE-ISO 35001:2021/Amd 1:2024 UNE
Status: Vigente/ 2024-04-03
Biorisk management for laboratories and other related organisations — Amendment 1: Climate action changes
UNE-EN ISO 15189:2023 UNE
Status: Vigente/ 2023-01-18
Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
UNE-EN ISO 20776-2:2022 UNE
Status: Vigente/ 2022-09-21
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)
UNE-EN ISO 4307:2022 UNE
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)
UNE-EN ISO 23162:2022 UNE
Status: Vigente/ 2022-07-27
Basic semen examination - Specification and test methods (ISO 23162:2021)
UNE-EN ISO 20166-4:2022 UNE
Status: Vigente/ 2022-03-16
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)
UNE-EN ISO 6717:2022 UNE
In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)
UNE-ISO 15190:2022 UNE
Status: Vigente/ 2022-03-02
Medical laboratories — Requirements for safety
UNE-EN ISO 20184-3:2022 UNE
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA (ISO 20184-3:2021)
UNE-EN ISO 23118:2022 UNE
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma (ISO 23118:2021)
UNE-EN ISO 17511:2022 UNE
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)
UNE-ISO 35001:2021 UNE
Status: Vigente/ 2021-03-17
Biorisk management for laboratorios and other related organisations
UNE-EN ISO 20776-1:2021 UNE
Status: Vigente/ 2021-02-10
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)
UNE-EN ISO 22367:2020 UNE
Status: Vigente/ 2020-10-21
Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020)
UNE-EN ISO 20186-3:2020 UNE
Status: Vigente/ 2020-09-23
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)
UNE-EN ISO 20186-2:2020 UNE
Status: Vigente/ 2020-01-08
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA (ISO 20186-2:2019)
UNE-EN ISO 20186-1:2019 UNE
Status: Vigente/ 2019-12-04
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019)
UNE-EN ISO 20166-3:2019 UNE
Status: Vigente/ 2019-10-23
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)
UNE-EN ISO 15195:2019 UNE
Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)
UNE-EN ISO 20166-1:2019 UNE
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)
UNE-EN ISO 20166-2:2019 UNE
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)
UNE-EN ISO 20184-2:2019 UNE
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins (ISO 20184-2:2018)
UNE-EN ISO 20184-1:2019 UNE
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA (ISO 20184-1:2018)
UNE-EN ISO 6710:2018 UNE
Status: Vigente/ 2018-06-06
Single-use containers for human venous blood specimen collection (ISO 6710:2017)
UNE-EN ISO 22870:2017 UNE
Status: Vigente/ 2017-03-29
Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016)
UNE-EN ISO 23640:2015 UNE
Status: Vigente/ 2015-09-23
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
UNE-EN ISO 15197:2015 UNE
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
UNE-EN ISO 15197:2013 UNE
Status: Anulada/ 2018-07-01
UNE-EN ISO 19001:2013 UNE
Status: Vigente/ 2013-11-27
In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013)
UNE-EN ISO 16256:2013 UNE
Status: Anulada/ 2024-11-01
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)
UNE-EN ISO 15189:2013 UNE
Status: Vigente/ 2014-11-26
Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
UNE-EN ISO 23640:2013 UNE
UNE-EN ISO 23640:2012 UNE
Status: Anulada/ 2013-04-03
UNE-EN ISO 18113-2:2012 UNE
Status: Vigente/ 2012-02-22
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
UNE-EN ISO 18113-1:2012 UNE
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
UNE-EN ISO 18113-3:2012 UNE
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
UNE-EN ISO 18113-4:2012 UNE
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
UNE-EN ISO 18113-5:2012 UNE
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
UNE-EN ISO 18113-3:2010 UNE
Status: Anulada/ 2014-11-01
UNE-EN ISO 18113-4:2010 UNE
