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
DIN CEN/TS 16945*DIN SPEC 13228:2016-11

DIN CEN/TS 16945*DIN SPEC 13228:2016-11

Superseded Historical

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for metabolomics in urine, venous blood serum and plasma; German version CEN/TS 16945:2016

€72.80

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DIN EN ISO 10993-4:2016-02

DIN EN ISO 10993-4:2016-02

Superseded Historical

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO/DIS 10993-4:2015); German and English version prEN ISO 10993-4:2015

€190.65

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DIN 58905-1:2015-12

DIN 58905-1:2015-12

Superseded Historical

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 58910-1:2016-02

DIN 58910-1:2016-02

Active Most Recent

Haemostaseology - Determination of thromboplastin (prothrombin) time - Part 1: Reference measurement procedure for the determination in plasma from citrated venous blood; Text in German and English

€48.79

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DIN 58932-3:2016-01

DIN 58932-3:2016-01

Superseded Historical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

€98.32

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DIN EN ISO 22442-1:2016-05

DIN EN ISO 22442-1:2016-05

Superseded Historical

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015); German version EN ISO 22442-1:2015

€116.64

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DIN EN ISO 22442-2:2016-05

DIN EN ISO 22442-2:2016-05

Superseded Historical

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015); German version EN ISO 22442-2:2015

€91.03

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DIN EN ISO 10993-16:2016-04

DIN EN ISO 10993-16:2016-04

Superseded Historical

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO/DIS 10993-16:2016); German and English version prEN ISO 10993-16:2016

€91.03

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DIN EN ISO 10993-6:2017-09

DIN EN ISO 10993-6:2017-09

Active Most Recent

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016); German version EN ISO 10993-6:2016

€122.34

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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 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 10993-9:2018-05

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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