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 CEN/TS 17390-3:2020

PD CEN/TS 17390-3:2020

Superseded Historical

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes circulating tumor cells (CTCs) venous whole blood Preparations analytical CTC staining

€193.00

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BS ISO 21474-2:2022

BS ISO 21474-2:2022

Active Most Recent

In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids Validation and verification

€269.00

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BS EN ISO 10993-16:2017

BS EN ISO 10993-16:2017

Active Most Recent

Biological evaluation of medical devices Toxicokinetic study design for degradation products and leachables

€255.00

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21/30416029 DC:2021

21/30416029 DC:2021

Active Most Recent

BS EN ISO 18113-1. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Part 1. Terms, definitions, and general requirements

€23.00

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BS EN ISO 18113-1:2024

BS EN ISO 18113-1:2024

Active Most Recent

In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions, and general requirements

€374.00

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21/30416033 DC:2021

21/30416033 DC:2021

Active Most Recent

BS EN ISO 18113-2. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Part 2. reagents for professional use

€23.00

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BS EN ISO 18113-2:2024

BS EN ISO 18113-2:2024

Active Most Recent

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

€269.00

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21/30416037 DC:2021

21/30416037 DC:2021

Active Most Recent

BS EN ISO 18113-3. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Part 3. instruments for professional use

€23.00

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BS EN ISO 18113-3:2024

BS EN ISO 18113-3:2024

Active Most Recent

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

€269.00

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21/30416041 DC:2021

21/30416041 DC:2021

Active Most Recent

BS EN ISO 18113-4. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Part 4. reagents for self-testing

€23.00

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BS EN ISO 18113-4:2024

BS EN ISO 18113-4:2024

Active Most Recent

In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) reagents for self-testing

€269.00

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21/30416045 DC:2021

21/30416045 DC:2021

Active Most Recent

BS EN ISO 18113-5. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Part 5. instruments for self-testing

€23.00

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BS EN ISO 18113-5:2024

BS EN ISO 18113-5:2024

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In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) Part 5: instruments for self-testing

€269.00

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BS EN ISO 20166-1:2018

BS EN ISO 20166-1:2018

Active Most Recent

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

€269.00

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BS EN ISO 20184-2:2018

BS EN ISO 20184-2:2018

Active Most Recent

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

€269.00

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