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
PD ISO/TS 11796:2023

PD ISO/TS 11796:2023

Active Most Recent

Biological evaluation of medical devices. Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices

€316.00

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24/30463717 DC:2023

24/30463717 DC:2023

Active Most Recent

BS EN ISO 15193 In vitro diagnostic medical devices - Requirements for reference measurement procedures

€23.00

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24/30463721 DC:2023

24/30463721 DC:2023

Active Most Recent

BS EN ISO 15194 In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation

€23.00

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PD ISO/TS 5441:2024

PD ISO/TS 5441:2024

Active Most Recent

Competence requirements for biorisk management advisors

€404.00

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24/30472744 DC:2024

24/30472744 DC:2024

Active Most Recent

BS ISO 7405 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

€23.00

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PD CEN/TS 16826-1:2015

PD CEN/TS 16826-1:2015

Superseded Historical

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

€193.00

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PD CEN/TS 16835-1:2015

PD CEN/TS 16835-1:2015

Superseded Historical

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

€269.00

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PD CEN/TS 16827-1:2015

PD CEN/TS 16827-1:2015

Superseded Historical

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

€269.00

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PD CEN/TS 16835-2:2015

PD CEN/TS 16835-2:2015

Superseded Historical

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

€269.00

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PD CEN/TS 16826-2:2015

PD CEN/TS 16826-2:2015

Superseded Historical

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

€193.00

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PD CEN/TS 16827-2:2015

PD CEN/TS 16827-2:2015

Superseded Historical

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes FFPE tissue Isolated proteins

€269.00

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24/30463896 DC:2024

24/30463896 DC:2024

Active Most Recent

BS EN ISO 18704 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA

€23.00

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DD ENV 13728:2001

DD ENV 13728:2001

Superseded Historical

Health informatics. Clinical analyser interfaces to laboratory information systems

€374.00

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BS EN 591:2001

BS EN 591:2001

Superseded Historical

Instructions for use for in vitro diagnostic instruments for professional use

€165.00

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BS EN 592:2002

BS EN 592:2002

Superseded Historical

Instructions for use for in vitro diagnostic instruments for self-testing

€165.00

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