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 EN ISO 18113-5:2013-01

DIN EN ISO 18113-5:2013-01

Superseded Historical

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009); German version EN ISO 18113-5:2011.

€77.20

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DIN EN ISO 18113-1:2013-01

DIN EN ISO 18113-1:2013-01

Superseded Historical

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009); German version EN ISO 18113-1:2011.

€140.00

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DIN ISO 13022:2014-06

DIN ISO 13022:2014-06

Active Most Recent

Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012)

€145.14

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DIN EN ISO 20776-2:2022-04

DIN EN ISO 20776-2:2022-04

Active Most Recent

Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution (ISO 20776-2:2021); German version EN ISO 20776-2:2022

€98.32

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DIN 58923:2022-05

DIN 58923:2022-05

Active Most Recent

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

€56.17

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DIN 58924:2022-05

DIN 58924:2022-05

Active Most Recent

Haemostaseology - Reference method for the determination of the collagen binding acitvity of the VWF; Text in German and English

€56.17

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DIN CEN/TS 17626:2022-01

DIN CEN/TS 17626:2022-01

Active Most Recent

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA; German version CEN/TS 17626:2021

€98.13

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DIN 58931:2021-02

DIN 58931:2021-02

Superseded Historical

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

€91.03

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DIN 58932-6:2021-02

DIN 58932-6:2021-02

Superseded Historical

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

€84.58

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DIN EN ISO 10993-2:2023-02

DIN EN ISO 10993-2:2023-02

Active Most Recent

Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022); German version EN ISO 10993-2:2022

€84.58

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DIN EN ISO 6717:2021-12

DIN EN ISO 6717:2021-12

Active Most Recent

In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021); German version EN ISO 6717:2021

€91.03

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DIN CEN/TS 17688-2:2022-06

DIN CEN/TS 17688-2:2022-06

Active Most Recent

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 2: Isolated proteins; German version CEN/TS 17688-2:2021

€78.50

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DIN CEN/TS 17688-1:2022-06

DIN CEN/TS 17688-1:2022-06

Active Most Recent

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 1: Isolated cellular RNA; German version CEN/TS 17688-1:2021

€98.13

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DIN CEN/TS 17688-3:2022-07

DIN CEN/TS 17688-3:2022-07

Active Most Recent

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 3: Isolated genomic DNA; German version CEN/TS 17688-3:2021

€93.36

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DIN EN ISO 22442-1:2021-08

DIN EN ISO 22442-1:2021-08

Active Most Recent

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020); German version EN ISO 22442-1:2020.

€122.34

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