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 10993-1 (09/2009):2009

NBN EN ISO 10993-1 (09/2009):2009

Superseded Historical

Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)

€50.00

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NBN EN ISO 10993-13:2009

NBN EN ISO 10993-13:2009

Superseded Historical

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)

€50.00

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NBN EN ISO 18113-1:2011

NBN EN ISO 18113-1:2011

Superseded Historical

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)

€50.00

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NBN EN ISO 22442-1:2015

NBN EN ISO 22442-1:2015

Superseded Historical

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)

€50.00

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NBN EN ISO 10993-9:2010

NBN EN ISO 10993-9:2010

Superseded Historical

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)

€50.00

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NBN EN ISO 19001:2013

NBN EN ISO 19001:2013

Active Most Recent

In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013)

€92.00

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NBN EN ISO 10993-12:2012

NBN EN ISO 10993-12:2012

Superseded Historical

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)

€50.00

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NBN ISO 35001:2020

NBN ISO 35001:2020

Active Most Recent

Biorisk management for laboratories and other related organisations

€121.00

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NBN ISO 21151:2021

NBN ISO 21151:2021

Active Most Recent

In vitro diagnostic medical devices — Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples

€121.00

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ISO/FDIS 22367:2026

ISO/FDIS 22367:2026

Forthcoming Most Recent

Medical laboratories — Application of risk management to medical laboratories

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NBN ISO 21474-3:2025

NBN ISO 21474-3:2025

Active Most Recent

In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 3: Interpretation and reports

€92.00

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NF EN ISO 10993-5/A11, S99-501-5/A11 (03/2025)

NF EN ISO 10993-5/A11, S99-501-5/A11 (03/2025)

Active Most Recent

Évaluation biologique des dispositifs médicaux - Partie 5 : essais concernant la cytotoxicité in vitro

€25.00

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NBN ISO 21474-1:2021

NBN ISO 21474-1:2021

Active Most Recent

In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluation

€121.00

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PR NF EN ISO 10993-11, S99-501-11PR (05/2025)

PR NF EN ISO 10993-11, S99-501-11PR (05/2025)

Active Most Recent

Évaluation biologique des dispositifs médicaux - Partie 11 : Essais de toxicité systémique

€135.00

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PR NF EN ISO 10993-3, S99-501-3PR (05/2025)

PR NF EN ISO 10993-3, S99-501-3PR (05/2025)

Active Most Recent

Évaluation biologique des dispositifs médicaux - Partie 3 : Évaluation de la génotoxicité, de la cancérogénicité, de la toxicité sur la reproduction et le développement

€135.00

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