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
NBN EN ISO 15193:2009

NBN EN ISO 15193:2009

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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)

€121.00

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NBN EN ISO 15194:2009

NBN EN ISO 15194:2009

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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)

€89.00

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NBN EN ISO 10993-13:2010

NBN EN ISO 10993-13:2010

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Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)

€92.00

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ISO/TS 20914:2019 (R2023)

ISO/TS 20914:2019 (R2023)

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Medical laboratories — Practical guidance for the estimation of measurement uncertainty

€235.00

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ISO 20916:2019 (R2025)

ISO 20916:2019 (R2025)

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In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice

€259.00

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ISO 15195:2018 (R2024)

ISO 15195:2018 (R2024)

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Laboratory medicine — Requirements for the competence of calibration laboratories using reference measurement procedures

€77.00

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ISO/TR 21582:2021

ISO/TR 21582:2021

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Pyrogenicity — Principles and methods for pyrogen testing of medical devices

€115.00

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ISO 22367:2020

ISO 22367:2020

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Medical laboratories — Application of risk management to medical laboratories

€261.00

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ISO 35001:2019

ISO 35001:2019

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Biorisk management for laboratories and other related organisations

€178.00

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ISO 14155:2020

ISO 14155:2020

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Clinical investigation of medical devices for human subjects — Good clinical practice

€261.00

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ISO 23118:2021

ISO 23118:2021

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Molecular in vitro diagnostic examinations — Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma

€115.00

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ISO 23162:2021

ISO 23162:2021

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Basic semen examination — Specification and test methods

€183.00

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ISO 24443:2021

ISO 24443:2021

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Cosmetics — Determination of sunscreen UVA photoprotection in vitro

€208.00

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ISO 15189:2022

ISO 15189:2022

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Medical laboratories — Requirements for quality and competence

€259.00

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ISO 16256:2021

ISO 16256:2021

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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

€115.00

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