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 ISO 22442-2:2015

BS EN ISO 22442-2:2015

Superseded Historical

Medical devices utilizing animal tissues and their derivatives Controls on sourcing, collection handling

€269.00

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BS EN ISO 15197:2015

BS EN ISO 15197:2015

Active Most Recent

In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

€374.00

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BS EN ISO 23640:2015

BS EN ISO 23640:2015

Active Most Recent

In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents

€193.00

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BS EN ISO 20184-1:2018

BS EN ISO 20184-1:2018

Active Most Recent

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes frozen tissue Isolated RNA

€269.00

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BS EN ISO 20186-1:2019

BS EN ISO 20186-1:2019

Active Most Recent

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes venous whole blood Isolated cellular RNA

€269.00

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BS EN ISO 20166-2:2018

BS EN ISO 20166-2:2018

Active Most Recent

Molecular in vitro diagnostic examinations. Specifications for pre-examinations processes formalin-fixed and paraffin-embedded (FFPE) tissue Isolated proteins

€269.00

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BS EN ISO 20166-3:2019

BS EN ISO 20166-3:2019

Active Most Recent

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes formalin-fixed and paraffin-embedded (FFPE) tissue Isolated DNA

€269.00

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BS EN ISO 15195:2019

BS EN ISO 15195:2019

Active Most Recent

Laboratory medicine. Requirements for the competence of calibration laboratories using reference measurement procedures

€193.00

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BS EN ISO 15193:2009

BS EN ISO 15193:2009

Active Most Recent

In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for content and presentation of reference measurement procedures

€269.00

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BS EN ISO 15194:2009

BS EN ISO 15194:2009

Active Most Recent

In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for certified reference materials and the content of supporting documentation

€269.00

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BS EN ISO 22870:2016

BS EN ISO 22870:2016

Superseded Historical

Point-of-care testing (POCT). Requirements for quality and competence

€193.00

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BS EN ISO 7405:2018

BS EN ISO 7405:2018

Superseded Historical

Dentistry. Evaluation of biocompatibility of medical devices used in dentistry

€374.00

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BS EN ISO 10993-1:2020

BS EN ISO 10993-1:2020

Superseded Historical

Biological evaluation of medical devices Evaluation and testing within a risk management process

€355.00

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BS EN ISO 6710:2017

BS EN ISO 6710:2017

Active Most Recent

Single-use containers for human venous blood specimen collection

€269.00

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PD ISO/TR 15499:2016

PD ISO/TR 15499:2016

Active Most Recent

Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process

€269.00

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