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 7405:2018

BS EN ISO 7405:2018

Superseded Historical

Dentistry. Evaluation of biocompatibility of medical devices used in dentistry

€374.00

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BS EN ISO 10993-1:2020

BS EN ISO 10993-1:2020

Superseded Historical

Biological evaluation of medical devices Evaluation and testing within a risk management process

€355.00

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PD ISO/TR 21582:2021

PD ISO/TR 21582:2021

Active Most Recent

Pyrogenicity. Principles and methods for pyrogen testing of medical devices

€269.00

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PD ISO/TS 16782:2016

PD ISO/TS 16782:2016

Active Most Recent

Clinical laboratory testing. Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing

€269.00

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BS EN ISO 6710:2017

BS EN ISO 6710:2017

Active Most Recent

Single-use containers for human venous blood specimen collection

€269.00

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PD ISO/TR 15499:2016

PD ISO/TR 15499:2016

Active Most Recent

Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process

€269.00

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BS EN ISO 10993-9:2021

BS EN ISO 10993-9:2021

Active Most Recent

Biological evaluation of medical devices Framework for identification and quantification potential degradation products

€269.00

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BS EN ISO 10993-15:2023

BS EN ISO 10993-15:2023

Active Most Recent

Biological evaluation of medical devices Identification and quantification degradation products from metals alloys

€269.00

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BS EN ISO 10993-7:2008+A1:2022

BS EN ISO 10993-7:2008+A1:2022

Active Most Recent

Biological evaluation of medical devices Ethylene oxide sterilization residuals

€404.00

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BS EN ISO 10993-1:October 2009

BS EN ISO 10993-1:October 2009

Superseded Historical

Biological evaluation of medical devices Evaluation and testing within a risk management process

€316.00

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BS ISO 20916:2019

BS ISO 20916:2019

Withdrawn Most Recent

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

€355.00

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BS ISO 21474-1:2020

BS ISO 21474-1:2020

Active Most Recent

In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids Terminology and general requirements acid quality evaluation

€269.00

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BS EN ISO 15189:2012

BS EN ISO 15189:2012

Withdrawn Most Recent

Medical laboratories. Requirements for quality and competence

€374.00

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PD ISO/TS 17822-1:2014

PD ISO/TS 17822-1:2014

Active Most Recent

In vitro diagnostic test systems. Qualitative nucleic acid-based in examination procedures for detection and identification of microbial pathogens General requirements, terms definitions

€316.00

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BS EN ISO 22442-1:2015

BS EN ISO 22442-1:2015

Superseded Historical

Medical devices utilizing animal tissues and their derivatives Application of risk management

€316.00

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