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
CEN/TS 17811:2022

CEN/TS 17811:2022

Superseded Historical

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA

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ISO 17511:2020 (R2026)

ISO 17511:2020 (R2026)

Active Most Recent

In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples

€235.00

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ISO 21151:2020 (R2026)

ISO 21151:2020 (R2026)

Active Most Recent

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

€155.00

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ISO 7405:2018

ISO 7405:2018

Superseded Historical

Dentistry — Evaluation of biocompatibility of medical devices used in dentistry

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PD ISO/TR 15499:2012

PD ISO/TR 15499:2012

Withdrawn Most Recent

Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process

€269.00

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BS EN ISO 10993-1:June 2009

BS EN ISO 10993-1:June 2009

Withdrawn Most Recent

Biological evaluation of medical devices Evaluation and testing

€269.00

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BS EN ISO 10993-18:2005

BS EN ISO 10993-18:2005

Withdrawn Most Recent

Biological evaluation of medical devices Chemical characterization materials

€269.00

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BS EN ISO 15195:2003

BS EN ISO 15195:2003

Withdrawn Most Recent

Laboratory medicine. Requirements for reference measurement laboratories

€269.00

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PD CEN/TS 16835-3:2015

PD CEN/TS 16835-3:2015

Withdrawn Most Recent

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes venous whole blood Isolated circulating cell free DNA from plasma

€193.00

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PD CEN/TS 16827-3:2015

PD CEN/TS 16827-3:2015

Withdrawn Most Recent

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes FFPE tissue Isolated DNA

€193.00

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BS EN ISO 10993-14:2001

BS EN ISO 10993-14:2001

Withdrawn Most Recent

Biological evaluation of medical devices Identification and quantification degradation products from ceramics

€269.00

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NF EN IEC 61326-2-6, C46-050-2-6 (06/2021)

NF EN IEC 61326-2-6, C46-050-2-6 (06/2021)

Superseded Historical

Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6 : particular requirements - In vitro diagnostic (IVD) medical equipment

€95.67

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NBN EN ISO 24443:2021/A1:2026

NBN EN ISO 24443:2021/A1:2026

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Cosmetics - Determination of sunscreen UVA photoprotection in vitro - Amendment 1 (ISO 24443:2021/Amd 1:2026)

€20.00

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NBN EN ISO 18704:2026

NBN EN ISO 18704:2026

Active Most Recent

Molecular in vitro diagnostic examinations - Requirements and recommendations for pre-examination processes for urine and other body fluids - Isolated cell-free DNA (ISO 18704:2026)

€124.00

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25/30482510 DC:2025

25/30482510 DC:2025

Active Most Recent

BS EN ISO 10993-16 Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables

€23.00

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