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 10993-9:May 2009

BS EN ISO 10993-9:May 2009

Superseded Historical

Framework for identification and quantification of potential degradation products

€193.00

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BS EN ISO 14155-2:2003

BS EN ISO 14155-2:2003

Superseded Historical

Clinical investigation of medical devices for human subjects plans

€193.00

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BS EN ISO 14155-1:2003

BS EN ISO 14155-1:2003

Superseded Historical

Clinical investigation of medical devices for human subjects General requirements

€316.00

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BS EN ISO 10993-4:2002

BS EN ISO 10993-4:2002

Superseded Historical

Biological evaluation of medical devices Selection tests for interactions with blood

€355.00

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BS EN ISO 15189:2003

BS EN ISO 15189:2003

Superseded Historical

Medical laboratories. Particular requirements for quality and competence

€374.00

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BS ISO 21474-3:2024

BS ISO 21474-3:2024

Active Most Recent

In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids Interpretation and reports

€269.00

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PD CEN ISO/TS 7552-1:2024

PD CEN ISO/TS 7552-1:2024

Active Most Recent

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes circulating tumour cells (CTCs) venous whole blood Isolated RNA

€269.00

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PD CEN ISO/TS 7552-2:2024

PD CEN ISO/TS 7552-2:2024

Active Most Recent

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes circulating tumour cells (CTCs) venous whole blood Isolated DNA

€269.00

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PD CEN ISO/TS 7552-3:2024

PD CEN ISO/TS 7552-3:2024

Active Most Recent

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

€269.00

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PD ISO/TS 16766:2024

PD ISO/TS 16766:2024

Active Most Recent

Manufacturers’ considerations for in vitro diagnostic medical devices in a public health emergency

€193.00

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24/30482475 DC:2024

24/30482475 DC:2024

Active Most Recent

BS EN ISO 10993-2 Biological evaluation of medical devices Part 2: Animal welfare requirements

€23.00

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BS EN ISO 5649:2024

BS EN ISO 5649:2024

Active Most Recent

Medical laboratories. Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests

€316.00

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BS EN ISO 14155:2020+A11:2024

BS EN ISO 14155:2020+A11:2024

Active Most Recent

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

€404.00

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UNE-EN ISO 15189:2023/A11:2024

UNE-EN ISO 15189:2023/A11:2024

Superseded Historical

Medical laboratories - Requirements for quality and competence

€28.00

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24/30482498 DC:2024

24/30482498 DC:2024

Active Most Recent

BS EN ISO 10993-23:2021/Amd 1 Biological evaluation of medical devices Part 23: Tests for irritation. AMENDMENT 1: Additional in vitro reconstructed human epidermis models

€23.00

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