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
NF EN 13641, S92-041 (10/2002)

NF EN 13641, S92-041 (10/2002)

Active Most Recent

Elimination or reduction of risk of infection related to in vitro diagnostic reagents

€51.24

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NF EN ISO 23640, S92-032 (12/2015)

NF EN ISO 23640, S92-032 (12/2015)

Active Most Recent

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents

€51.24

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NF EN ISO 15197, S92-026 (12/2015)

NF EN ISO 15197, S92-026 (12/2015)

Active Most Recent

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

€100.63

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NF EN ISO 10993-11, S99-501-11 (05/2018)

NF EN ISO 10993-11, S99-501-11 (05/2018)

Active Most Recent

Biological evaluation of medical devices - Part 11 : tests for systemic toxicity

€117.00

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NF EN ISO 17511, S92-021 (01/2004)

NF EN ISO 17511, S92-021 (01/2004)

Superseded Historical

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials - Dispositifs médicaux de diagnostic in vitro

€84.02

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NF EN ISO 18153, S92-022 (01/2004)

NF EN ISO 18153, S92-022 (01/2004)

Active Most Recent

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials - Dispositifs médicaux de diagnostic in vitro

€73.30

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NF EN 13975, S92-033 (10/2003)

NF EN 13975, S92-033 (10/2003)

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Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects - Procédures d'échantillonnage utilisées pour l'acceptation des essais des dispositifs médicaux de diagnostic in vitro

€64.01

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NF EN 14136, S92-035 (07/2004)

NF EN 14136, S92-035 (07/2004)

Active Most Recent

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

€51.24

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NF EN ISO 20776-2, S92-053-2 (10/2007)

NF EN ISO 20776-2, S92-053-2 (10/2007)

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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 - Systèmes d'essais en laboratoire et de diagnostic in vitro

€51.24

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NF EN ISO 10993-18, S99-501-18 (05/2020)

NF EN ISO 10993-18, S99-501-18 (05/2020)

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Biological evaluation of medical devices - Part 18 : chemical characterization of medical device materials within a risk management process

€167.33

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NF EN ISO 10993-13, S99-501-13 (09/2010)

NF EN ISO 10993-13, S99-501-13 (09/2010)

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Biological evaluation of medical devices - Part 13 : identification and quantification of degradation products from polymeric medical devices

€82.00

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NF EN ISO 10993-9, S99-501-9 (05/2010)

NF EN ISO 10993-9, S99-501-9 (05/2010)

Superseded Historical

Biological evaluation of medical devices - Part 9 : framework for identification and quantification of potential degradation products

€62.33

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NF EN ISO 10993-1, S99-501-1 (07/2010)

NF EN ISO 10993-1, S99-501-1 (07/2010)

Superseded Historical

Biological evaluation of medical devices - Part 1 : evaluation and testing within a risk management system process

€89.33

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NF EN ISO 15194, S92-020 (10/2009)

NF EN ISO 15194, S92-020 (10/2009)

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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 - Dispositifs médicaux de diagnostic in vitro

€75.67

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NF EN ISO 15193, S92-019 (10/2009)

NF EN ISO 15193, S92-019 (10/2009)

Active Most Recent

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures - Dispositifs médicaux de diagnostic in vitro

€73.30

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