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
UNE-EN ISO 10993-12:2022

UNE-EN ISO 10993-12:2022

Active Most Recent

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)

€80.00

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UNE-EN ISO 20184-3:2022

UNE-EN ISO 20184-3:2022

Active Most Recent

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA (ISO 20184-3:2021)

€72.00

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UNE-EN ISO 23118:2022

UNE-EN ISO 23118:2022

Active Most Recent

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma (ISO 23118:2021)

€73.00

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UNE-EN ISO 20166-4:2022

UNE-EN ISO 20166-4:2022

Active Most Recent

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)

€85.00

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UNE-EN ISO 10993-9:2022

UNE-EN ISO 10993-9:2022

Active Most Recent

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)

€69.00

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UNE-EN ISO 23162:2022

UNE-EN ISO 23162:2022

Active Most Recent

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

€94.00

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UNE-EN ISO 20776-2:2022

UNE-EN ISO 20776-2:2022

Active Most Recent

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)

€74.00

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UNE-EN ISO 4307:2022

UNE-EN ISO 4307:2022

Active Most Recent

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

€69.00

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UNE-EN ISO 10993-2:2023

UNE-EN ISO 10993-2:2023

Active Most Recent

Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)

€72.00

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UNE-EN ISO 10993-10:2023

UNE-EN ISO 10993-10:2023

Active Most Recent

Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)

€120.00

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UNE-EN ISO 10993-15:2024

UNE-EN ISO 10993-15:2024

Active Most Recent

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)

€75.00

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UNE-EN ISO 10993-17:2024

UNE-EN ISO 10993-17:2024

Active Most Recent

Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)

€129.00

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UNE-EN ISO 10993-18:2021/A1:2024

UNE-EN ISO 10993-18:2021/A1:2024

Active Most Recent

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor (ISO 10993-18:2020/Amd 1:2022)

€59.00

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NF EN ISO 20776-1, S92-053-1 (04/2007)

NF EN ISO 20776-1, S92-053-1 (04/2007)

Superseded Historical

Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1 : reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases - Systèmes d'essais en laboratoire et de diagnostic in vitro

€83.50

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UNE-EN ISO 10993-6:2017

UNE-EN ISO 10993-6:2017

Active Most Recent

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)

€94.00

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