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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-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 4307:2022 UNE
Status: Vigente/ 2022-09-21
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)
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-EN ISO 20184-3:2022 UNE
Status: Vigente/ 2022-03-02
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-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 13975:2003 UNE
Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
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 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 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 15194:2009 UNE
Status: Vigente/ 2014-09-03
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)
UNE-EN 13612/AC:2003 UNE
Status: Vigente/ 2014-04-09
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 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 13079:2011 UNE
Status: Vigente/ 2011-11-16
Laboratory glass and plastics ware. Tubes and support for the measurement of erythrocytic sedimentation rate by the Westergren method (ISO 13079:2011)
UNE-EN ISO 29701:2010 UNE
Status: Vigente/ 2010-10-01
Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test (ISO 29701:2010) (Endorsed by AENOR in October of 2010.)
UNE-EN ISO 15193:2009 UNE
Status: Vigente/ 2009-11-25
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)
ISO 18113-5:2022 ISO
Status: Published/ 2022-10-06
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
ISO 18113-3:2022 ISO
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
ISO 18113-4:2022 ISO
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
