CLSI M40 Volunteer Application

CLSI M40 | Quality Control of Microbiological Transport Systems, 3rd Edition

CLSI M40 will provide information on guidance for manufacturers of specimen collection and transport devices for quality control testing of, but not limited to, the container, transport medium, collection device, packaging, and environmental factors. This standard provides guidance to the manufacturer in addressing critical issues related to the type of testing to be performed (eg, bacterial or viral culture; antigen or nucleic acid detection). CLSI M40 also focuses on the methods for quality control testing and acceptance criteria in order to provide a product suitable for the analysis of clinical specimens for specific disease agents.

This group is looking for volunteers with:

• Knowledge of and/or first-hand experience with current quality control and/or manufacturing of microbiological collection and transport systems and/or quality control and testing for modifications performed to regulatory-cleared collection devices.

   

• Knowledge of and/or first-hand experience of current regulatory requirements and development of quality control standard for microbiological collection and transport systems/devices.

Estimated Timeline 

• April 2026: First meeting (may include review of document scope and outline, assignment of writing teams)
• May 2026 to March 2027: Drafting of document (higher-intensity volunteer time period)
• May 2027 to June 2027: Voting period for draft document
• July 2027 to September 2027: Revision of draft based on comments received during voting
• February 2028: Expected Final Draft approval date

Apply on or before 9 February 2026.