CTN 129 : CLINICAL LABORATORY AND IN VITRO DIAGNOSTIC SYSTEMS

UNE-EN ISO 5649:2025

UNE-EN ISO 5649:2025

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Medical laboratories - Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests (ISO 5649:2024)

€98.00

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UNE-EN ISO 18113-1:2025

UNE-EN ISO 18113-1:2025

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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022)

€122.00

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UNE-EN ISO 18113-2:2025

UNE-EN ISO 18113-2:2025

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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022)

€76.00

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UNE-EN ISO 18113-3:2025

UNE-EN ISO 18113-3:2025

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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2022)

€73.00

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UNE-EN ISO 18113-4:2025

UNE-EN ISO 18113-4:2025

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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022)

€73.00

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UNE-EN ISO 18113-5:2025

UNE-EN ISO 18113-5:2025

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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022)

€71.00

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UNE-EN ISO 20916:2024

UNE-EN ISO 20916:2024

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In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)

€132.00

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UNE-ISO 35001:2021/Amd 1:2024

UNE-ISO 35001:2021/Amd 1:2024

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Biorisk management for laboratories and other related organisations — Amendment 1: Climate action changes

€0.00

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UNE-EN ISO 15189:2023

UNE-EN ISO 15189:2023

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Medical laboratories - Requirements for quality and competence (ISO 15189:2022)

€132.00

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UNE-EN ISO 20776-2:2022

UNE-EN ISO 20776-2:2022

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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)

€76.00

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UNE-EN ISO 4307:2022

UNE-EN ISO 4307:2022

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Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)

€71.00

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UNE-EN ISO 23162:2022

UNE-EN ISO 23162:2022

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Basic semen examination - Specification and test methods (ISO 23162:2021)

€96.00

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UNE-EN ISO 6717:2022

UNE-EN ISO 6717:2022

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In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)

€71.00

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UNE-EN ISO 20166-4:2022

UNE-EN ISO 20166-4:2022

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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)

€87.00

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UNE-EN ISO 17511:2022

UNE-EN ISO 17511:2022

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In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)

€129.00

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