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
21/30416045 DC:2021

21/30416045 DC:2021

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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 22367:2020

BS EN ISO 22367:2020

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Medical laboratories. Application of risk management to medical laboratories

€404.00

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21/30425530 DC:2021

21/30425530 DC:2021

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BS EN ISO 20776-2. Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility of infectious agents evaluation performance antimicrobial susceptibility Part 2. Evaluation devices against reference broth micro-dilution

€23.00

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PD ISO/TS 5798:2022

PD ISO/TS 5798:2022

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In vitro diagnostic test systems. Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods

€374.00

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24/30453916 DC:2024

24/30453916 DC:2024

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BS EN ISO 10993-7 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals

€42.00

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24/30467406 DC:2024

24/30467406 DC:2024

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BS EN ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice

€42.00

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24/30482506 DC:2024

24/30482506 DC:2024

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BS EN ISO 10993-12:2021/Amd 1 Biological evaluation of medical devices Part 12: Sample preparation and reference materials

€23.00

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24/30451085 DC:2024

24/30451085 DC:2024

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BS EN ISO 10993-1 Biological evaluation of medical devices Part 1. Evaluation and testing within a risk management process

€23.00

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22/30447779 DC:2022

22/30447779 DC:2022

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BS ISO 20658. Medical laboratories. Requirements for collection and transport of samples

€23.00

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23/30449561 DC:2023

23/30449561 DC:2023

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BS ISO 21474-3. In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids Part 3. Interpretation and reports

€23.00

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PD ISO/TS 23824:2024

PD ISO/TS 23824:2024

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Medical laboratories. Guidance on application of ISO 15189 in anatomic pathology

€316.00

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PD CEN/TS 17981-1:2023

PD CEN/TS 17981-1:2023

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In vitro diagnostic Next Generation Sequencing (NGS) workflows Human DNA examination

€374.00

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PD CEN/TS 17981-2:2023

PD CEN/TS 17981-2:2023

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In vitro diagnostic Next Generation Sequencing (NGS) workflows Human RNA examination

€374.00

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24/30453873 DC:2024

24/30453873 DC:2024

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BS EN ISO 10993-6 Biological evaluation of medical devices Part 6: Tests for local effects after implantation

€23.00

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PD ISO/TR 10993-55:2023

PD ISO/TR 10993-55:2023

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Biological evaluation of medical devices Interlaboratory study on cytotoxicity

€269.00

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