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
ISO 18113-1:2022

ISO 18113-1:2022

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

€235.00

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ISO 18113-2:2022

ISO 18113-2:2022

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

€77.00

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ISO 18113-3:2022

ISO 18113-3:2022

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

€77.00

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ISO 18113-4:2022

ISO 18113-4:2022

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

€77.00

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ISO 18113-5:2022

ISO 18113-5:2022

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

€77.00

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ISO 20658:2023

ISO 20658:2023

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Requirements for the collection and transport of samples for medical laboratory examinations

€208.00

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ISO 6717:2021

ISO 6717:2021

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In vitro diagnostic medical devices — Single-use containers for the collection of specimens from humans other than blood

€115.00

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ISO/TS 5798:2022 (R2026)

ISO/TS 5798:2022 (R2026)

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In vitro diagnostic test systems — Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods

€208.00

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NBN EN ISO 10993-10:2013

NBN EN ISO 10993-10:2013

Superseded Historical

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)

€50.00

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NBN EN ISO 20776-2:2022

NBN 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)

€92.00

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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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NBN EN ISO 20186-3:2019

NBN EN ISO 20186-3:2019

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Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma (ISO 20186-3:2019)

€92.00

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NBN EN ISO 10993-18:2020

NBN EN ISO 10993-18:2020

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Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)

€187.00

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ISO 7713:1985 (R2024)

ISO 7713:1985 (R2024)

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Laboratory glassware — Disposable serological pipettes

€51.00

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ISO 21474-2:2022

ISO 21474-2:2022

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In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids Part 2: Validation and verification

€115.00

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