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
XP CEN/TS 16827-3, S92-071-3 (10/2015)

XP CEN/TS 16827-3, S92-071-3 (10/2015)

Superseded Historical

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 3 : isolated DNA

€78.00

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XP CEN/TS 16835-1, S92-075-1 (08/2015)

XP CEN/TS 16835-1, S92-075-1 (08/2015)

Superseded Historical

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 veineux total - Partie 1 : ARN cellulaire isolé

€72.00

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NF EN ISO 5649, S92-088 (12/2024)

NF EN ISO 5649, S92-088 (12/2024)

Active Most Recent

Laboratoires médicaux - Concepts et spécifications relatifs à la conception, au développement, à la mise en œuvre et à l’utilisation des tests développés en laboratoire

€117.00

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NF EN ISO 10993-4/A1, S99-501-4/A1 (02/2025)

NF EN ISO 10993-4/A1, S99-501-4/A1 (02/2025)

Active Most Recent

Évaluation biologique des dispositifs médicaux - Partie 4 : choix des essais pour les interactions avec le sang - Amendement 1

€59.00

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PR NF EN ISO 15194, S92-020PR (02/2024)

PR NF EN ISO 15194, S92-020PR (02/2024)

Active Most Recent

Dispositifs médicaux de diagnostic in vitro - Exigences relatives aux matériaux de référence certifiés et au contenu de la documentation associée

€105.50

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

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

Active Most Recent

Dispositifs médicaux de diagnostic in vitro - Exigences relatives aux procédures de mesure de référence

€116.50

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DIN CEN/TS 16826-3*DIN SPEC 58991:2018-09

DIN CEN/TS 16826-3*DIN SPEC 58991:2018-09

Superseded Historical

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 3: Isolated DNA; German version CEN/TS 16826-3:2018

€67.48

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DIN EN ISO 20186-3:2018-02

DIN EN ISO 20186-3:2018-02

Superseded Historical

Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Cellular RNA - Part 3: Isolated circulating cell free DNA from plasma (ISO/DIS 20186-3:2018); German and English version prEN ISO 20186-3:2018

€91.03

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DIN EN ISO 15195:2018-05

DIN EN ISO 15195:2018-05

Superseded Historical

Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO/DIS 15195:2018); German and English version prEN ISO 15195:2018

€77.20

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DIN EN ISO 10993-11:2018-09

DIN EN ISO 10993-11:2018-09

Active Most Recent

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017); German version EN ISO 10993-11:2018

€128.22

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DIN 58989:2017-11

DIN 58989:2017-11

Superseded Historical

Haemostaseology - HPLC-MS methods for the quantification of direct oral anticoagulants (DOAC) - Rivaroxaban; Text in German and English

€63.27

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DIN 58905-1:2016-12

DIN 58905-1:2016-12

Active Most Recent

Haemostaseology - Blood collection - Part 1: Preparation of plasma from citrated venous blood for coagulation testing; Text in German and English

€63.27

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DIN 58932-3:2017-01

DIN 58932-3:2017-01

Superseded Historical

Haematology - Determination of the concentration of blood corpuscles in blood - Part 3: Reference method for the determination of the concentration of erythrozytes; Text in German and English

€105.42

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DIN EN ISO 10993-9:2018-05

DIN EN ISO 10993-9:2018-05

Superseded Historical

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO/DIS 10993-9:2018); German and English version prEN ISO 10993-9:2018

€91.03

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DIN EN ISO 10993-15:2018-05

DIN EN ISO 10993-15:2018-05

Superseded Historical

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO/DIS 10993-15:2018); German and English version prEN ISO 10993-15:2018

€98.32

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