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Language: English

ISO 35001: Biorisk management for laboratories and other related organisations

[ISO 35001]
International Organization for Standardization (ISO)

This document defines a process to identify, assess, control, and monitor the risks associated with hazardous biological materials. This document is applicable to any laboratory or other organization that works with, stores, transports, and/or disposes of hazardous biological materials.


The International Organization for Standardization (ISO) 35001: Biorisk management for laboratories and other related organisations standards outline a process for laboratories to identify, assess, control and monitor potentially hazardous biological materials. It was designed to be used as a standard for lab certification and as a gap analysis tool. The standard, published in November 2019, has quickly gained recognition in the field and was recommended by many of the experts interviewed for this library.

ISO 35001 was developed by the ISO technical committee 212: Clinical laboratory testing and in vitro diagnostic test systems, which was composed of global experts from the field. ISO 35001 builds off of ISO 45001: Occupational health and safety management system standard, which is a more general workplace risk management standard. ISO also links this document with Sustainable Development Goal 3: Good Health and Well Being. The Standard is available for purchase through ISO, and is published in English.