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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-CEN ISO/TS 7552-1:2024 UNE
Status: Current/ 2024-12-01
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood - Part 1: Isolated RNA (ISO/TS 7552-1:2024) (Endorsed by Asociación Española de Normalización in December of 2024.)
UNE-CEN ISO/TS 7552-3:2024 UNE
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood - Part 3: Preparations for analytical CTC staining (ISO/TS 7552-3:2024) (Endorsed by Asociación Española de Normalización in December of 2024.)
UNE-CEN ISO/TS 7552-2:2024 UNE
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood - Part 2: Isolated DNA (ISO/TS 7552-2:2024) (Endorsed by Asociación Española de Normalización in December of 2024.)
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-CEN/TS 17981-2:2023 UNE
Status: Vigente/ 2024-01-01
In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 2: Human RNA examination (Endorsed by Asociación Española de Normalización in January of 2024.)
UNE-CEN/TS 17981-1:2023 UNE
In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 1: Human DNA examination (Endorsed by Asociación Española de Normalización in January of 2024.)
UNE-EN ISO 15189:2023 UNE
Status: Vigente/ 2023-01-18
Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
UNE-CEN ISO/TS 5798:2022 UNE
Status: Vigente/ 2023-01-01
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) (Endorsed by Asociación Española de Normalización in January of 2023.)
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-CEN/TS 17747:2022 UNE
Status: Vigente/ 2022-06-01
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins (Endorsed by Asociación Española de Normalización in June of 2022.)
UNE-CEN/TS 17742:2022 UNE
Status: Vigente/ 2022-05-01
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma (Endorsed by Asociación Española de Normalización in May of 2022.)
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-CEN/TS 17688-2:2021 UNE
Status: Vigente/ 2022-02-01
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 2: Isolated proteins (Endorsed by Asociación Española de Normalización in February of 2022.)
UNE-CEN/TS 17688-1:2021 UNE
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 1: Isolated cellular RNA (Endorsed by Asociación Española de Normalización in February of 2022.)
UNE-CEN/TS 17688-3:2021 UNE
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 3: Isolated genomic DNA (Endorsed by Asociación Española de Normalización in February of 2022.)
UNE-EN ISO 16256:2021 UNE
Status: Vigente/ 2021-12-01
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) (Endorsed by Asociación Española de Normalización in December of 2021.)
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 13612:2002 UNE
Status: Vigente/ 2020-02-20
Performance evaluation of in vitro diagnostic medical devices.
UNE-EN 13532:2002 UNE
General requirements for in vitro diagnostic medical devices for self-testing.
UNE-EN 13641:2002 UNE
Elimination or reduction of risk of infection related to in vitro diagnostic reagents.
UNE-EN 13975:2003 UNE
Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
UNE-EN 14136:2004 UNE
Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
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 1659:1997 UNE
Status: Vigente/ 2019-03-14
In vitro diagnostic systems - Culture media for microbiology - Terms and definitions
UNE-EN 12322:1999 UNE
In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
UNE-EN ISO 6710:2018 UNE
Status: Vigente/ 2018-06-06
Single-use containers for human venous blood specimen collection (ISO 6710:2017)
