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 18113-2:2011

BS EN ISO 18113-2:2011

Withdrawn Most Recent

In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) reagents for professional use

€269.00

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ISO 7405:2025

ISO 7405:2025

Active Most Recent

-- What is ISO 7405?

€229.00

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BS ISO 15190:2003

BS ISO 15190:2003

Withdrawn Most Recent

Medical laboratories. Requirements for safety

€355.00

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PD CEN/TS 17811:2022

PD CEN/TS 17811:2022

Superseded Historical

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for urine and other body fluids. Isolated cell free DNA

€269.00

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NF EN ISO 15189, S92-060 (10/2014)

NF EN ISO 15189, S92-060 (10/2014)

Superseded Historical

Medical laboratories - Requirements for quality and competence - Laboratoires d'analyses de biologie médicale

€70.67

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BS EN ISO 10993-9:December 2009

BS EN ISO 10993-9:December 2009

Withdrawn Most Recent

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

€193.00

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DD CEN ISO/TS 22367:2010

DD CEN ISO/TS 22367:2010

Withdrawn Most Recent

Medical laboratories. Reduction of error through risk management and continual improvement

€193.00

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BS EN ISO 10993-12:2012

BS EN ISO 10993-12:2012

Withdrawn Most Recent

Biological evaluation of medical devices Sample preparation and reference materials

€316.00

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BS EN ISO 10993-15:2009

BS EN ISO 10993-15:2009

Withdrawn Most Recent

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

€193.00

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BS EN ISO 10993-17:2009

BS EN ISO 10993-17:2009

Withdrawn Most Recent

Biological evaluation of medical devices Establishment allowable limits for leachable substances

€316.00

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25/30487902 DC:2025

25/30487902 DC:2025

Active Most Recent

BS ISO 24884 Electronic Instructions for Use for In Vitro Diagnostic Medical Devices — Minimum required information and means of delivery

€23.00

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UNE-EN 592:1995

UNE-EN 592:1995

Superseded Historical

IN VITRO DIAGNOSTIC SYSTEMS. REQUIREMENTS FOR USER MANUAL FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR HOME USE.

€53.00

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PD ISO/TS 7446:2026

PD ISO/TS 7446:2026

Active Most Recent

Implementation guidance for biorisk management for laboratories and other related organizations

€404.00

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BS EN ISO 10993-7:1996

BS EN ISO 10993-7:1996

Withdrawn Most Recent

Biological evaluation of medical devices Ethylene oxide sterilization residuals

€355.00

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25/30479947 DC:2025

25/30479947 DC:2025

Active Most Recent

BS EN ISO 22367 Medical laboratories - Application of risk management to medical laboratories

€23.00

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