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
UNE-EN ISO 10993-5:2009

UNE-EN ISO 10993-5:2009

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Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

€91.00

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UNE-EN ISO 10993-1:2010

UNE-EN ISO 10993-1:2010

Superseded Historical

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

€77.00

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UNE-EN ISO 10993-9:2010

UNE-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Superseded Historical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)

€69.00

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UNE-EN ISO 10993-1:2010/AC:2010

UNE-EN ISO 10993-1:2010/AC:2010

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Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - Technical Corrigendum 1 (ISO 10993-1:2009/Cor 1:2010)

€0.00

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UNE-EN ISO 10993-13:2010

UNE-EN ISO 10993-13:2010

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Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)

€69.00

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UNE-EN ISO 13079:2011

UNE-EN ISO 13079:2011

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Laboratory glass and plastics ware. Tubes and support for the measurement of erythrocytic sedimentation rate by the Westergren method (ISO 13079:2011)

€69.00

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UNE-EN ISO 18113-3:2012

UNE-EN ISO 18113-3:2012

Superseded Historical

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)

€62.00

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UNE-EN ISO 18113-5:2012

UNE-EN ISO 18113-5:2012

Superseded Historical

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)

€61.00

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NF EN ISO 22367, S92-081 (03/2020)

NF EN ISO 22367, S92-081 (03/2020)

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Medical laboratories - Application of risk management to medical laboratories

€159.33

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NF EN ISO 20166-4, S92-071-4 (07/2021)

NF EN ISO 20166-4, S92-071-4 (07/2021)

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Molecular in vitro diagnostic examinations - Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 4 : In situ detection techniques

€107.33

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NF EN ISO 10993-23, S99-501-23 (03/2021)

NF EN ISO 10993-23, S99-501-23 (03/2021)

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Biological evaluation of medical devices - Part 23 : tests for irritation - Évaluation biologique des dispositifs médicaux - Partie 23 : Essais d'irritation

€156.67

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NF ISO 21151, S92-080 (12/2020)

NF ISO 21151, S92-080 (12/2020)

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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 - Dispositifs médicaux de diagnostic in vitro - Mesurage de quantités dans les échantillons d'origine biologique - Exigences relatives aux protocoles d'harmonisation internationaux établissant la traçabilité métrologique des valeurs affectées aux étalons et aux échantillons humains

€89.33

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NF ISO 20916, S92-082 (09/2019)

NF ISO 20916, S92-082 (09/2019)

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In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice

€156.67

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NF EN ISO 7405, S91-224 (11/2018)

NF EN ISO 7405, S91-224 (11/2018)

Superseded Historical

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

€125.67

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NF EN ISO 20166-1, S92-071-1 (12/2018)

NF EN ISO 20166-1, S92-071-1 (12/2018)

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Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 1 : isolated RNA

€83.67

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