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UNE-EN ISO 18113-4:2025
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 18113-3:2025
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 18113-5:2025
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 18113-2:2025
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 18113-1:2025
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022)
UNE-CEN ISO/TS 7552-1:2024
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 7552-2:2024
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-CEN ISO/TS 7552-3:2024
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-EN ISO 20916:2024
In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
UNE-EN ISO 15378:2018/A1:2024
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) - Amendment 1: Climate action changes (ISO 15378:2017/Amd 1:2024)
UNE-EN ISO 15189:2023/A11:2024
Medical laboratories - Requirements for quality and competence
UNE-CEN/TS 17981-2:2023
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
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
Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
UNE-EN ISO 4307:2022
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)
UNE-CEN/TS 17747:2022
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins (Endorsed by Asociación Española de Normalización in June of 2022.)
UNE-CEN/TS 17742:2022
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
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
In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)
UNE-EN ISO 17511:2022
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-EN ISO 20184-3:2022
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
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma (ISO 23118:2021)
UNE-ISO 15190:2022
Medical laboratories — Requirements for safety
UNE-EN ISO 11737-1:2018/A1:2022
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)