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 ISO 20186-1, S92-075-1 (03/2019)

NF EN ISO 20186-1, S92-075-1 (03/2019)

Active Most Recent

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1 : isolated cellular RNA - Tests de diagnostic moléculaire in vitro - Spécifications relatives aux processus pré-analytiques pour le sang - ARN cellulaire - Partie 1 : ARN cellulaire extrait

€86.67

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NF EN ISO 20186-2, S92-075-2 (03/2019)

NF EN ISO 20186-2, S92-075-2 (03/2019)

Active Most Recent

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2 : isolated genomic DNA - Tests de diagnostic moléculaire in vitro - Spécifications relatives aux processus pré-analytiques pour le sang - ARN cellulaire - Partie 2 : ADN génomique extrait

€86.67

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NF EN ISO 20186-3, S92-075-3 (10/2019)

NF EN ISO 20186-3, S92-075-3 (10/2019)

Active Most Recent

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3 : isolated circulating cell free DNA from plasma - Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus pré-analytiques pour le sang total veineux - Partie 3 : ADN libre circulant extrait du plasma

€75.67

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NF EN ISO 10993-7/A1, S99-501-7/A1 (01/2022)

NF EN ISO 10993-7/A1, S99-501-7/A1 (01/2022)

Active Most Recent

Biological evaluation of medical devices - Part 7 : Ethylene oxide sterilization residuals - Amendment 1

€47.00

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NF EN ISO 20776-1, S92-053-1 (07/2020)

NF EN ISO 20776-1, S92-053-1 (07/2020)

Active Most Recent

Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1 : broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases - Sensibilité in vitro des agents infectieux et évaluation des performances des dispositifs pour antibiogrammes - Partie 1 : Méthode de référence de microdilution en bouillon pour la détermination de la sensibilité in vitro aux agents antimicrobiens des bactéries aérobies à croissance rapide

€78.00

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NF EN ISO 14155, S99-201 (08/2020)

NF EN ISO 14155, S99-201 (08/2020)

Active Most Recent

Clinical investigation of medical devices for human subjects - Good clinical practice - Investigation clinique des dispositifs médicaux pour sujets humains - Bonnes pratiques cliniques

€159.33

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FD ISO/TR 10993-22, S99-501-22 (08/2017)

FD ISO/TR 10993-22, S99-501-22 (08/2017)

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Biological evaluation of medical devices - Part 22 : guidance on nanomaterials

€156.67

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NF EN ISO 22442-2, S97-601-2 (12/2020)

NF EN ISO 22442-2, S97-601-2 (12/2020)

Active Most Recent

Medical devices utilizing animal tissues and their derivatives - Part 2 : controls on sourcing, collection and handling

€78.00

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NF EN ISO 10993-4, S99-501-4 (07/2018)

NF EN ISO 10993-4, S99-501-4 (07/2018)

Active Most Recent

Biological evaluation of medical devices - Part 4 : selection of tests for interactions with blood - Evaluation biologique des dispositifs médicaux - Partie 4 : Choix des essais pour les interactions avec le sang

€167.33

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FD CEN/TR 17223, S99-212 (11/2018)

FD CEN/TR 17223, S99-212 (11/2018)

Withdrawn Most Recent

Guidance on the relationship between EN ISO 13485:2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation - Document d'orientation sur la relation entre l'EN ISO 13485:2016 (Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires) et le Règlement européen relatif aux dispositifs médicaux ainsi que le Règlement relatif aux dispositifs médicaux de diagnostic in

€163.33

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NF EN IEC 61010-2-101, C42-020-2-101 (11/2022)

NF EN IEC 61010-2-101, C42-020-2-101 (11/2022)

Active Most Recent

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

€95.67

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DIN 58984-1:1984-02

DIN 58984-1:1984-02

Withdrawn Most Recent

Special laboratory medicine; determination of inorganic substances in serum, plasma, urine and other body fluids; determination of calcium by atomic absorption spectrometry

€41.78

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DIN 12847-1:1984-05

DIN 12847-1:1984-05

Active Most Recent

Laboratory glassware; haemacytometer counting chambers; general requirements

€34.30

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NF EN ISO 18113-5, S92-010-5 (05/2012)

NF EN ISO 18113-5, S92-010-5 (05/2012)

Superseded Historical

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5 : in vitro diagnostic instruments for self-testing - Dispositifs médicaux de diagnostic in vitro

€58.33

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NF EN ISO 18113-4, S92-010-4 (05/2012)

NF EN ISO 18113-4, S92-010-4 (05/2012)

Superseded Historical

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4 : in vitro diagnostic reagents for self-testing - Dispositifs médicaux de diagnostic in vitro

€70.75

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