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 5736-3:1981

BS 5736-3:1981

Superseded Historical

Evaluation of medical devices for biological hazards Method test systemic toxicity; assessment acute toxicity extracts from

€165.00

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BS 5736-4:1981

BS 5736-4:1981

Withdrawn Most Recent

Evaluation of medical devices for biological hazards Method test intracutaneous reactivity extracts from

€165.00

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BS 5736-5:1982

BS 5736-5:1982

Superseded Historical

Evaluation of medical devices for biological hazards Method test systemic toxicity; assessment pyrogenicity in rabbits extracts from

€165.00

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BS 5736-6:1983

BS 5736-6:1983

Superseded Historical

Evaluation of medical devices for biological hazards Methods test sensitization; assessment the potential to produce delayed contact dermatitis

€165.00

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BS 5736-7:1983

BS 5736-7:1983

Superseded Historical

Evaluation of medical devices for biological hazards Method test skin irritation extracts from

€165.00

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BS 5736-8:1984

BS 5736-8:1984

Superseded Historical

Evaluation of medical devices for biological hazards Method test skin irritation solid

€165.00

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BS 748:1982

BS 748:1982

Withdrawn Most Recent

Specification for haemacytometer and particle counting chambers

€165.00

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PD CEN/TS 16945:2016

PD CEN/TS 16945:2016

Withdrawn Most Recent

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

€193.00

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BS EN ISO 14155:2011

BS EN ISO 14155:2011

Withdrawn Most Recent

Clinical investigation of medical devices for human subjects. Good clinical practice

€374.00

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BS EN ISO 18113-3:2011

BS EN ISO 18113-3:2011

Withdrawn Most Recent

In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) instruments for professional use

€193.00

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BS EN ISO 18113-2:2011

BS EN ISO 18113-2:2011

Withdrawn Most Recent

In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) reagents for professional use

€269.00

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PD CEN/TS 17811:2022

PD CEN/TS 17811:2022

Superseded Historical

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for urine and other body fluids. Isolated cell free DNA

€269.00

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DD CEN ISO/TS 22367:2010

DD CEN ISO/TS 22367:2010

Withdrawn Most Recent

Medical laboratories. Reduction of error through risk management and continual improvement

€193.00

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PD ISO/TS 7446:2026

PD ISO/TS 7446:2026

Active Most Recent

Implementation guidance for biorisk management for laboratories and other related organizations

€404.00

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25/30500985 DC:2025

25/30500985 DC:2025

Active Most Recent

Draft BS EN 63521 Machine Learning-enabled Medical Device. Performance Evaluation Process

€23.00

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