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
BS EN 13612:2002

BS EN 13612:2002

Active Most Recent

Performance evaluation of in vitro diagnostic medical devices

€193.00

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BS EN ISO 20776-1:2006

BS EN ISO 20776-1:2006

Superseded Historical

Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility of infectious agents evaluation performance antimicrobial susceptibility devices Reference method for the activity against rapidly growing aerobic bacteria involved diseases

€269.00

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BS EN ISO 20776-2:2007

BS EN ISO 20776-2:2007

Superseded Historical

Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility of infectious agents evaluation performance antimicrobial susceptibility devices Evaluation

€193.00

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BS EN ISO 22442-3:2007

BS EN ISO 22442-3:2007

Active Most Recent

Medical devices utilizing animal tissues and their derivatives Validation of the elimination and/or inactivation viruses transmissible spongiform encephalopathy (TSE) agents

€316.00

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BS EN 14254:2004

BS EN 14254:2004

Superseded Historical

In vitro diagnostic medical devices. Single-use receptacles for the collection of specimens, other than blood, from humans

€193.00

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BS ISO 15198:2004

BS ISO 15198:2004

Active Most Recent

Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user quality control procedures by the manufacturer

€193.00

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BS ISO 17593:2007

BS ISO 17593:2007

Superseded Historical

Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

€374.00

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PD ISO/TR 22442-4:2010

PD ISO/TR 22442-4:2010

Active Most Recent

Medical devices utilizing animal tissues and their derivatives Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents validation assays those processes

€269.00

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BS EN ISO 16256:2012

BS EN ISO 16256:2012

Superseded Historical

Clinical laboratory testing and in vitro diagnostic test systems. Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases

€269.00

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BS EN ISO 22442-1:2020

BS EN ISO 22442-1:2020

Active Most Recent

Medical devices utilizing animal tissues and their derivatives Application of risk management

€316.00

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BS EN ISO 23118:2021

BS EN ISO 23118:2021

Active Most Recent

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma

€269.00

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BS EN ISO 23162:2021

BS EN ISO 23162:2021

Active Most Recent

Basic semen examination. Specification and test methods

€316.00

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BS EN ISO 10993-12:2021

BS EN ISO 10993-12:2021

Active Most Recent

Biological evaluation of medical devices Sample preparation and reference materials

€299.00

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BS ISO 15190:2020

BS ISO 15190:2020

Active Most Recent

Medical laboratories. Requirements for safety

€404.00

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BS EN ISO 10993-10:2023

BS EN ISO 10993-10:2023

Active Most Recent

Biological evaluation of medical devices Tests for skin sensitization

€374.00

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