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ISO 35001:2019

Biorisk management for laboratories and other related organisations

Publication date:   Nov 12, 2019

General information

90.92   Standard to be revised   Nov 28, 2025

ISO

ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems

International Standard

11.100.01   Laboratory medicine in general | 03.100.70   Management systems | 07.100.01   Microbiology in general

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Scope

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. This document is intended to complement existing International Standards for laboratories.
This document is not intended for laboratories that test for the presence of microorganisms and/or toxins in food or feedstuffs. This document is not intended for the management of risks from the use of genetically modified crops in agriculture.

Life cycle

NOW

PUBLISHED
ISO 35001:2019
90.92 Standard to be revised
Nov 28, 2025

CORRIGENDA / AMENDMENTS

PUBLISHED
ISO 35001:2019/Amd 1:2024

REVISED BY

IN_DEVELOPMENT
ISO/AWI 35001

Relations

Adopted from CWA 15793:2011