11.100 : Laboratory medicine

11.100.01

Laboratory medicine in general

11.100.10

In vitro diagnostic test systems

11.100.20

Biological evaluation of medical devices

11.100.30

Analysis of blood and urine

11.100.99

Other standards related to laboratory medicine
NF EN ISO 17511, S92-021 (07/2021)

NF EN ISO 17511, S92-021 (07/2021)

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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

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NF EN ISO 10993-15, S99-501-15 (06/2023)

NF EN ISO 10993-15, S99-501-15 (06/2023)

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Évaluation biologique des dispositifs médicaux - Partie 15 : identification et quantification des produits de dégradation issus des métaux et alliages

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NF EN ISO 22442-1, S97-601-1 (01/2021)

NF EN ISO 22442-1, S97-601-1 (01/2021)

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Medical devices utilizing animal tissues and their derivatives - Part 1 : application of risk management

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NF EN ISO 16256, S92-012 (10/2021)

NF EN ISO 16256, S92-012 (10/2021)

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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

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NF EN ISO 18113-1, S92-010-1 (07/2024)

NF EN ISO 18113-1, S92-010-1 (07/2024)

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Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 1 : termes, définitions et exigences générales

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NF EN ISO 18113-2, S92-010-2 (07/2024)

NF EN ISO 18113-2, S92-010-2 (07/2024)

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Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 2 : réactifs de diagnostic in vitro à usage professionnel

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NF EN ISO 18113-5, S92-010-5 (07/2024)

NF EN ISO 18113-5, S92-010-5 (07/2024)

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Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 5 : instruments de diagnostic in vitro destinés aux autodiagnostics

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NF ISO 20658, S92-085 (06/2023)

NF ISO 20658, S92-085 (06/2023)

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Exigences pour le prélèvement et le transport d’échantillons à des fins d’examens en laboratoire médical

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NF EN ISO 5649, S92-088 (12/2024)

NF EN ISO 5649, S92-088 (12/2024)

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Laboratoires médicaux - Concepts et spécifications relatifs à la conception, au développement, à la mise en œuvre et à l’utilisation des tests développés en laboratoire

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ASTM C1379-10

ASTM C1379-10

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Standard Test Method for Analysis of Urine for Uranium-235 and Uranium-238 Isotopes by Inductively Coupled Plasma-Mass Spectrometry (Withdrawn 2017)

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ASTM F2383-11

ASTM F2383-11

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Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs) (Withdrawn 2020)

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ASTM F2903-11

ASTM F2903-11

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Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair (Withdrawn 2020)

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ASTM F2883-11

ASTM F2883-11

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Standard Guide for Characterization of Ceramic and Mineral Based Scaffolds used for Tissue-Engineered Medical Products (TEMPs) and as Device for Surgical Implant Applications (Withdrawn 2020)

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UNE 129003:2000 EX

UNE 129003:2000 EX

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Nomenclature, syntax and expression of the values of biological quantities.

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UNE 129002:2000 IN

UNE 129002:2000 IN

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Glossary of recommended terms in clinical laboratory sciences.

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