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 22367:2020

BS EN ISO 22367:2020

Active Most Recent

Medical laboratories. Application of risk management to medical laboratories

€404.00

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BS EN ISO 4307:2021

BS EN ISO 4307:2021

Active Most Recent

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA

€193.00

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BS EN ISO 16256:2021

BS EN ISO 16256:2021

Active Most Recent

Clinical laboratory testing and in vitro diagnostic test systems. Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases

€269.00

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BS EN ISO 6717:2021

BS EN ISO 6717:2021

Active Most Recent

In vitro diagnostic medical devices. Single-use containers for the collection of specimens from humans other than blood

€193.00

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21/30425530 DC:2021

21/30425530 DC:2021

Withdrawn Most Recent

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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BS EN ISO 20776-2:2021

BS EN ISO 20776-2:2021

Active Most Recent

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

€269.00

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BS ISO 17822:2020

BS ISO 17822:2020

Active Most Recent

In vitro diagnostic test systems. Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens. Laboratory quality practice guide

€355.00

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BS EN ISO 20916:2024

BS EN ISO 20916:2024

Active Most Recent

In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice

€404.00

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PD ISO/TS 5798:2022

PD ISO/TS 5798:2022

Active Most Recent

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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BS EN ISO 10993-18:2020+A1:2023

BS EN ISO 10993-18:2020+A1:2023

Active Most Recent

Biological evaluation of medical devices Chemical characterization device materials within a risk management process

€404.00

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NF EN ISO 10993-1, S99-501-1 (12/2020)

NF EN ISO 10993-1, S99-501-1 (12/2020)

Superseded Historical

Biological evaluation of medical devices - Part 1 : evaluation and testing within a risk management process - Évaluation biologique des dispositifs médicaux - Partie 1 : Évaluation et essais au sein d'un processus de gestion du risque

€128.67

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24/30453916 DC:2024

24/30453916 DC:2024

Active Most Recent

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

Active Most Recent

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

Active Most Recent

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

Active Most Recent

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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