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
DIN EN ISO 22442-2:2018-12

DIN EN ISO 22442-2:2018-12

Superseded Historical

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO/DIS 22442-2:2018); German and English version prEN ISO 22442-2:2018

€98.32

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ISO 17822:2020

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

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ISO/TS 20658:2017

ISO/TS 20658:2017

Superseded Historical

Medical laboratories — Requirements for collection, transport, receipt, and handling of samples

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ISO 22870:2016 (R2022)

ISO 22870:2016 (R2022)

Superseded Historical

Point-of-care testing (POCT) — Requirements for quality and competence

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ISO/TS 21726:2019 (R2022)

ISO/TS 21726:2019 (R2022)

Active Most Recent

Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents

€115.00

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ISO/TS 16782:2016 (R2021)

ISO/TS 16782:2016 (R2021)

Active Most Recent

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

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ISO 15190:2020

ISO 15190:2020

Active Most Recent

Medical laboratories — Requirements for safety

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ISO/TS 22583:2019

ISO/TS 22583:2019

Superseded Historical

Guidance for supervisors and operators of point-of-care testing (POCT) devices

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ISO/TS 23824:2024

ISO/TS 23824:2024

Active Most Recent

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

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ISO 17593:2022

ISO 17593:2022

Active Most Recent

Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

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ISO/TS 5441:2024

ISO/TS 5441:2024

Active Most Recent

Competence requirements for biorisk management advisors

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ISO 5649:2024

ISO 5649:2024

Active Most Recent

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

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ISO/FDIS 15193:2024

ISO/FDIS 15193:2024

Forthcoming Most Recent

In vitro diagnostic medical devices — Requirements for reference measurement procedures

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ISO/FDIS 15194:2024

ISO/FDIS 15194:2024

Forthcoming Most Recent

In vitro diagnostic medical devices — Requirements for certified reference materials and the content of supporting documentation

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ISO/TS 11796:2023

ISO/TS 11796:2023

Active Most Recent

Biological evaluation of medical devices — Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices

€183.00

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