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
PR NF EN ISO 15193, S92-019PR (02/2024)

PR NF EN ISO 15193, S92-019PR (02/2024)

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Dispositifs médicaux de diagnostic in vitro - Exigences relatives aux procédures de mesure de référenceAutomatic translation from French : In vitro diagnostic medical devices - Requirements for reference measurement procedures

€116.50

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UNE-EN ISO 10993-3:2015

UNE-EN ISO 10993-3:2015

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Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

€93.00

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UNE-EN ISO 23640:2015

UNE-EN ISO 23640:2015

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In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

€59.00

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UNE-EN ISO 15195:2004

UNE-EN ISO 15195:2004

Superseded Historical

Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003)

€69.00

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UNE-EN 14136:2004 (R2020)

UNE-EN 14136:2004 (R2020)

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

€60.00

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UNE-EN 14254:2004 (R2019)

UNE-EN 14254:2004 (R2019)

Superseded Historical

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

€69.00

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NF EN 12322, S92-051 (07/1999)

NF EN 12322, S92-051 (07/1999)

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In vitro diagnostic medical devices. Culture media for microbiology. Performance criteria for culture media. - Dispositifs médicaux de diagnostic in vitro

€64.01

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NF S91-141 (11/1997) (R2012)

NF S91-141 (11/1997) (R2012)

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biodegradability of dental metal alloys. Standardization of electrochemical tests. - Biodégradabilité des alliages métalliques utilisés en art dentaire

€82.00

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NF EN 61010-2-101, C42-739 (03/2003)

NF EN 61010-2-101, C42-739 (03/2003)

Superseded Historical

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101 : particular requirements for in vitro diagnostic (IVD) medical equipment

€106.33

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NF EN 13532, S92-024 (11/2002)

NF EN 13532, S92-024 (11/2002)

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General requirements for in vitro diagnostic medical devices for self-testing

€51.24

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NF EN 13612, S92-025 (09/2002)

NF EN 13612, S92-025 (09/2002)

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Performance evaluation of in vitro diagnostic medical devices

€73.30

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UNE-EN ISO 20776-1:2007

UNE-EN ISO 20776-1:2007

Superseded Historical

Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2006)

€71.00

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UNE-EN ISO 20776-2:2008

UNE-EN ISO 20776-2:2008

Superseded Historical

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 (ISO 20776-2:2007)

€60.00

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UNE-EN ISO 10993-12:2013

UNE-EN ISO 10993-12:2013

Superseded Historical

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

€77.00

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UNE-EN ISO 16256:2013

UNE-EN ISO 16256:2013

Superseded Historical

Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases (ISO 16256:2012)

€69.00

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