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
BS EN ISO 17511:2021

BS EN ISO 17511:2021

Active Most Recent

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

€374.00

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BS ISO 21151:2020

BS ISO 21151:2020

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

€269.00

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BS EN ISO 20166-4:2021

BS EN ISO 20166-4:2021

Active Most Recent

Molecular in vitro diagnostic examinations. Specifications for preexamination processes formalin-fixed and paraffin-embedded (FFPE) tissue In situ detection techniques

€316.00

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21/30379304 DC:2021

21/30379304 DC:2021

Active Most Recent

BS EN ISO 10993-17. Biological evaluation of medical devices Part 17. Toxicological risk assessment device constituents

€23.00

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BS EN ISO 10993-17:2023

BS EN ISO 10993-17:2023

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Biological evaluation of medical devices Toxicological risk assessment device constituents

€404.00

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PD CEN/TS 17305:2019

PD CEN/TS 17305:2019

Superseded Historical

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA

€193.00

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PD ISO/TS 22583:2019

PD ISO/TS 22583:2019

Superseded Historical

Guidance for supervisors and operators of point-of-care testing (POCT) devices

€316.00

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BS EN ISO 22442-2:2020

BS EN ISO 22442-2:2020

Active Most Recent

Medical devices utilizing animal tissues and their derivatives Controls on sourcing, collection handling

€269.00

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PD ISO/TS 20914:2019

PD ISO/TS 20914:2019

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Medical laboratories. Practical guidance for the estimation of measurement uncertainty

€404.00

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19/30381866 DC:2019

19/30381866 DC:2019

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BS ISO 17822-2. In vitro diagnostic test systems. Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens Part 2. Laboratory quality practice guide

€23.00

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PR NF ISO 22544, B36-471PR (04/2025)

PR NF ISO 22544, B36-471PR (04/2025)

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Conception de laboratoire - Vocabulaire

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ASTM E3231-19(2025)

ASTM E3231-19(2025)

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Standard Guide for Cell Culture Growth Assessment of Single-Use Material

€65.00

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ASTM F2259-25

ASTM F2259-25

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Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy

€65.00

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ASTM F624-25

ASTM F624-25

Active Most Recent

Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Medical Applications

€72.00

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ASTM F2212-25

ASTM F2212-25

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Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)

€72.00

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