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 58987:2010-03

DIN 58987:2010-03

Superseded Historical

Haemostaseology - Reference method for the VWF antigen; Text in German and English

€69.91

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DIN 58988:2010-03

DIN 58988:2010-03

Superseded Historical

Haemostaseology - Reference method for the VWF multimeres; Text in German and English

€63.27

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DIN EN ISO 10993-16:2010-06

DIN EN ISO 10993-16:2010-06

Superseded Historical

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010); German version EN ISO 10993-16:2010

€84.58

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DIN EN ISO 10993-10:2010-12

DIN EN ISO 10993-10:2010-12

Superseded Historical

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010); German version EN ISO 10993-10:2010

€173.74

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DIN EN ISO 10993-13:2010-11

DIN EN ISO 10993-13:2010-11

Active Most Recent

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010); German version EN ISO 10993-13:2010

€91.03

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DIN EN ISO 14155:2012-01

DIN EN ISO 14155:2012-01

Superseded Historical

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011 + Cor. 1:2011); German version EN ISO 14155:2011 + AC:2011

€157.10

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DIN EN ISO 16256:2011-09

DIN EN ISO 16256:2011-09

Superseded Historical

Clinical laboratory testing and in vitro diagnostic systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases (ISO/DIS 16256:2011); German version prEN ISO 16256:2011

€84.58

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DIN EN ISO 20776-1:2007-02

DIN EN ISO 20776-1:2007-02

Superseded Historical

Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2006); German version EN ISO 20776-1:2006

€98.32

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DIN EN ISO 14155-2:2003-09

DIN EN ISO 14155-2:2003-09

Superseded Historical

Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); German version EN ISO 14155-2:2003.

€69.91

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DIN EN ISO 17511:2003-11

DIN EN ISO 17511:2003-11

Superseded Historical

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003); German version EN ISO 17511:2003

€105.42

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DIN EN ISO 18153:2003-11

DIN EN ISO 18153:2003-11

Active Most Recent

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003); German version EN ISO 18153:2003

€77.20

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DIN EN ISO 15197:2013-11

DIN EN ISO 15197:2013-11

Superseded Historical

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013); German version EN ISO 15197:2013.

€140.00

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DIN EN ISO 10993-3:2015-02

DIN EN ISO 10993-3:2015-02

Active Most Recent

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014); German version EN ISO 10993-3:2014

€122.34

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DIN EN ISO 24443:2013-05

DIN EN ISO 24443:2013-05

Superseded Historical

Determination of sunscreen UVA photoprotection in vitro (ISO 24443:2012); German version EN ISO 24443:2012

€105.42

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DIN ISO 13022:2013-07

DIN ISO 13022:2013-07

Superseded Historical

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

€145.14

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