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 18113-3:2025

UNE-EN ISO 18113-3:2025

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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2022)

€71.00

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UNE-EN ISO 18113-4:2025

UNE-EN ISO 18113-4:2025

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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022)

€71.00

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UNE-EN ISO 18113-5:2025

UNE-EN ISO 18113-5:2025

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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022)

€69.00

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NF EN ISO 14155/A11, S99-201/A11 (12/2024)

NF EN ISO 14155/A11, S99-201/A11 (12/2024)

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Investigation clinique des dispositifs médicaux pour sujets humains - Bonne pratique clinique

€52.00

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NF EN ISO 10993-10, S99-501-10 (09/2009)

NF EN ISO 10993-10, S99-501-10 (09/2009)

Superseded Historical

Biological evaluation of medical devices - Part 10 : tests for irritation and delayed-type hypersensitivity

€134.67

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NF EN ISO 10993-9, S99-501-9 (12/2009)

NF EN ISO 10993-9, S99-501-9 (12/2009)

Superseded Historical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 10993-13, S99-501-13 (12/2009)

NF EN ISO 10993-13, S99-501-13 (12/2009)

Superseded Historical

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

€78.00

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NF EN ISO 10993-1, S99-501-1 (09/2009)

NF EN ISO 10993-1, S99-501-1 (09/2009)

Superseded Historical

Biological evaluation of medical devices - Part 1 : evaluation and testing

€70.50

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NF EN ISO 10993-16, S99-501-16 (08/2009)

NF EN ISO 10993-16, S99-501-16 (08/2009)

Superseded Historical

Biological evaluation of medical devices - Part 16 : toxicokinetic study design for degradation products and leachables

€78.00

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NF EN ISO 10993-12, S99-512 (03/2008)

NF EN ISO 10993-12, S99-512 (03/2008)

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Biological evaluation of medical devices - Part 12 : sample preparation and reference materials

€78.00

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PR NF EN 455-3/A1 (11/2025)

PR NF EN 455-3/A1 (11/2025)

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Gants médicaux non réutilisables - Partie 3 : Exigences et essais pour évaluation biologique

€38.50

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NF EN 455-3, S97-003 (02/2007)

NF EN 455-3, S97-003 (02/2007)

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Gants médicaux non réutilisables - Partie 3 : exigences et essais pour évaluation biologique

€89.33

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UNE-EN ISO 10993-4:2018/A1:2025

UNE-EN ISO 10993-4:2018/A1:2025

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Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/Amd 1:2025, Corrected version 2025-04)

€62.00

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UNE-EN ISO 10993-5:2009/A11:2025

UNE-EN ISO 10993-5:2009/A11:2025

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Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

€40.00

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NF EN 455-3, S97-003 (05/2000)

NF EN 455-3, S97-003 (05/2000)

Superseded Historical

Gants médicaux non réutilisables - Partie 3 : exigences et essais pour évaluation biologique

€84.50

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