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 58932-6:2021-08

DIN 58932-6:2021-08

Active Most Recent

Haematology - Determination of the concentration of blood corpuscles in blood - Part 6: Reference method for the determination of the concentration of CD4 positive lymphocytes; Text in German and English

€91.03

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DIN EN ISO 18113-1:2021-09

DIN EN ISO 18113-1:2021-09

Superseded Historical

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO/DIS 18113-1:2021); German and English version prEN ISO 18113-1:2021

€157.10

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DIN EN ISO 18113-2:2021-09

DIN EN ISO 18113-2:2021-09

Superseded Historical

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO/DIS 18113-2:2021); German and English version prEN ISO 18113-2:2021

€91.03

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DIN EN ISO 18113-3:2021-09

DIN EN ISO 18113-3:2021-09

Superseded Historical

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/DIS 18113-3:2021); German and English version prEN ISO 18113-3:2021

€77.20

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DIN EN ISO 18113-4:2021-09

DIN EN ISO 18113-4:2021-09

Superseded Historical

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/DIS 18113-4:2021); German and English version prEN ISO 18113-4:2021

€84.58

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DIN EN ISO 18113-5:2021-09

DIN EN ISO 18113-5:2021-09

Superseded Historical

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/DIS 18113-5:2021); German and English version prEN ISO 18113-5:2021

€77.20

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DIN 58931:2021-09

DIN 58931:2021-09

Active Most Recent

Haematology - Determination of haemoglobin concentration in blood - Reference method; Text in German and English

€91.03

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DIN EN ISO 10993-10:2023-04

DIN EN ISO 10993-10:2023-04

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Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021); German version EN ISO 10993-10:2023

€150.65

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DIN EN ISO 10993-18/A1:2021-10

DIN EN ISO 10993-18/A1:2021-10

Superseded Historical

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor (ISO 10993-18:2020/DAM 1:2021); German and English version EN ISO 10993-18:2020/prA1:2021

€48.79

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DIN CEN/TS 17742:2022-07

DIN CEN/TS 17742:2022-07

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Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma; German version CEN/TS 17742:2022

€72.80

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DIN 58912-1:2021-11

DIN 58912-1:2021-11

Active Most Recent

Haemostaseology - Determination of the antithrombin activity - Part 1: Reference measurement procedure using a synthetic peptide substrate; Text in German and English

€56.17

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DIN CEN/TS 17747:2022-08

DIN CEN/TS 17747:2022-08

Active Most Recent

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins; German version CEN/TS 17747:2022

€84.49

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DIN EN ISO 4307:2022-02

DIN EN ISO 4307:2022-02

Active Most Recent

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021); German version EN ISO 4307:2021

€84.58

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DIN EN ISO 15189:2021-11

DIN EN ISO 15189:2021-11

Superseded Historical

Medical laboratories - Requirements for quality and competence (ISO/DIS 15189:2021); German and English version prEN ISO 15189:2021

€162.06

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DIN 58923:2021-11

DIN 58923:2021-11

Superseded Historical

Haemostaseology - Reference method for the ristocetin-cofactor activity of the VWF; Text in German and English

€56.17

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