Biosafety Standards

ISO 35001:2019 Biorisk management for laboratories and other related organisations

Published (Edition 1, 2019). does not explicitly define numerical thresholds for what constitutes a "very rare event" (e.g., 1  in 1,000,000 years). Instead, it adopts a qualitative risk management approach, focusing on the likelihood and consequences of events involving biological materials. Biorisk Definition: “Biorisk is the effect of uncertainty expressed by the combination of the consequences of an event (including changes in circumstances) and the associated likelihood of occurrence, where biological material is the source of harm.” The standard emphasizes identifying, assessing, controlling, and evaluating risks.

It encourages organizations to consider low-probability, high-consequence events, but does not assign specific frequencies to such events. Unlike  nuclear safety standards (define “very rare” as 1 in million years or less), ISO 35001 leaves the definition of likelihoods to the lab organization. This allows for context-specific interpretation, which can be aligned with national regulations or internal risk matrices. ISO 35001 is based on and expands upon CWA 15793, which also did not define “very rare” numerically but emphasized ALARP (As Low As Reasonably Practicable) principles. 

1 November 2025

ISO/DTS 7446 Implementation guidance for biorisk management for laboratories and other related organizations

Publication date: 2026-01, Edition: 1, Number of pages: 139

Interesting study on Biosafety standards by Rose Hadshar, 2023; Standards may have impeded safety work in some areas; Researchers view standards as a barrier ; The evidence base for bio standards is poor; Bio standards tend to lack reporting 

13 January 2025

"Overview WHO LBM4

The WHO Laboratory Biosafety Manual (LBM) has been in broad use at all levels of clinical and public health laboratories, and other biomedical sectors globally, serving as a de facto global standard that presents best practices and sets trends in biosafety.

LBM encouraged countries to accept and implement basic concepts in biological safety and to develop national codes of practice for the safe handling of biological agents in laboratories within their geographical borders.

This fourth edition of the manual builds on the risk assessment framework introduced in the third edition. A thorough, evidence-based and transparent assessment of the risks allows safety measures to be balanced with the actual risk of working with biological agents on a case-by-case basis.

This novel evidence- and risk-based approach will allow optimised resource use and sustainable laboratory biosafety and biosecurity policies and practices that are relevant to their individual circumstances and priorities, enabling equitable access to clinical and public health laboratory tests and biomedical research opportunities without compromising safety." WHO LBM4

Supersedes the 2006 édition

The WHO laboratory biosecurity guidance follows and complements the revision of the Laboratory biosafety manual, fourth edition and provides principles and measures to prevent lapses and incidents throughout the whole value chain of handling high-consequence biological material, technology and information. The document shares global best practice and covers the biosecurity part of the biological risk management lifecycle, starting from collection, transportation, storage and experiment, and in specific context such as every type of biomedical laboratory, research activities, repository and biobank. It also provides key considerations and best practices for institutional, national and international levels, including regulatory oversight. Key elements of the guidance are:

Consequence-driven biosecurity risk assessment

• Emerging technologies and potential threats (Cybersecurity, information security; molecular techniques, artificial intelligence)

• International and national legislation/regulation

• two-tier system of the national body and the institutions using a hybrid approach with risk-based elements of list-based high-consequence material

• Strengthening the role and responsibility of institutional biosafety committees

• Ultimate situations – war, civil unrest, devastating natural disasters

The United States CDC and NIH made this standard, it has served as the cornerstone of biosafety practice in the United States since its initial release in 1984. 

The Biosafety in Microbiological and Biomedical Laboratories (BMBL) is an advisory guide, not a regulatory document. 

Its main purpose is to recommend best practices for biosafety in biomedical and clinical labs, emphasizing protocol-driven risk assessment rather than prescribing universal rules. 

This 6th edition includes updated sections, harmonized recommendations, and new appendices on topics like inactivation verification, sustainability, large-scale biosafety, and clinical lab safety. 

In Canada, the handling or storing of Risk Group 2 (RG2), RG3, and RG4 human pathogens or toxins is regulated by the Public Health Agency of Canada (PHAC) under the Human Pathogens and Toxins Act (HPTA) and the Human Pathogens and Toxins Regulations (HPTR). Under the Health of Animals Act (HAA) and the Health of Animals Regulations (HAR), the PHAC and the Canadian Food Inspection Agency (CFIA) regulate the importation of animal pathogens or part of one (e.g., toxin), animals naturally or experimentally exposed to an animal pathogen or part of one (e.g., toxin), and animal products or by-products (e.g., tissue, serum), or other organisms carrying an animal pathogen or part of one (e.g., toxin).

The Government of Canada's Canadian Biosafety Standard, Third Edition (CBS), 2022 is the national standard for facilities where regulated human and terrestrial animal pathogens and toxins are handled or stored.

Chinese standard for general requirement of biosafety laboratories BSL-1, 2, 3, 4 and ABSL-1, 2, 3, 4

Chinese standard for design and construction of biosafety laboratories

1-Laboratory Biosafety

appendix

      TB negative pressure laboratory RG3 storage location.odt

      BSL-4 Laboratory Biosafety and Biosecurity Checklist.odt

      ABSL-3 Laboratory Biosafety and Biosecurity Checklist.odt

      BSL-3 Laboratory Biosafety and Biosecurity Checklist.odt

      ABSL-2 Laboratory Biosafety and Biosecurity Checklist.odt

      BSL-2 Laboratory Biosafety and Biosecurity Checklist.odt

      Laboratory Biosafety Guidelines_20211221

      Laboratory Biosafety Standards_20210604

      Frequently Asked Questions (FAQs) on Laboratory Biosafety Standards (2021 Edition)

      Biosafety Guidelines for Clinical Diagnostic Testing Laboratories_20220318

2-Laboratory Biosecurity

appendix

      Biosecurity Plan Guidelines_1110511.pdf

      Laboratory Biosecurity Management Standards_20230911

      Biosafety Management – ​​Laboratory Biosecurity Guidelines_20100831

3-Laboratory Biosafety Standards and Guidelines for Pathogens

2026/02/06: Updated laboratory biosafety guidelines for novel coronavirus (SARS-CoV-2).

appendix

      Laboratory Biosafety Guidelines for Novel Coronavirus (SARS-CoV-2)_20260203

      Biosafety Guidelines for Handling and Testing of Specimens from Suspected or Confirmed Mpox Patients_20240110

      Lentiviral Vector Guidelines_20220401

      Laboratory Biosafety Guidelines for Handling Fever with Thrombocytopenia Syndrome Virus_20201104.pdf

      Laboratory Biosafety Guidelines for Handling Suspected Yersinia pestis Specimens and Pathogens_20200917.pdf

      Laboratory Biosafety Checklist for Routine Testing and Packaging Transportation of Specimens from Suspected Ebola Virus Infection Patients_1080719

      Laboratory Biosafety Guidelines for Human Immunodeficiency Virus_20230601

      Laboratory Biosafety Guidelines for Handling Middle East Respiratory Syndrome Virus Specimens_20190702

      Laboratory Biosafety Guidelines for Handling Ebola Virus Infected Patient Specimens and Pathogens_20190702

      Laboratory Biosafety Regulations for Handling Suspected Rabies Specimens and Pathogens_20190702

      Laboratory Biosafety Regulations for Handling Bacteria Carrying the NDM-1 Gene_20130723

      Laboratory Biosafety Regulations for Handling Human Specimens and Pathogens Suspected of Novel Influenza A_20170301

      Guidelines for Risk Assessment and Post-Exposure Management of Laboratory Personnel Handling Brucella - 20150917

      Tuberculosis Laboratory Biosafety Manual_20150313

      Laboratory Biosafety Guidelines for Nipah Virus_20260402

4-Emergency Response/Unexpected Events

appendix

      Laboratory Biosafety Accident and Disaster Response Plan Guidelines_20121025

      Standard Operating Procedures for Fire Protection and Earthquake Protection in Microbiology Laboratories (Template) _ 20130115

5. Packaging for transporting infectious materials

appendix

      Safe transport of infectious disease specimens_20210506.pdf

      Safety Q&A for the Transportation of Infectious Disease Specimens_20210406.pdf

      Guidelines for the Transportation of Infectious Substances (2019-2020)_20191230.pdf

      Training Plan for Shippers of Infectious Substances by Air (Template) _ 20150707

6. Personal Protective Equipment

      N-95 Mask Fit Test (Quantitative Method) _ 20141030

7-Guidelines for the Assessment of Biosafety Knowledge and Competence of Laboratory Personnel

      Laboratory Personnel Biosafety Knowledge and Competency Assessment Guidelines_20190701