CLSI M40

Quality Control of Microbiological Transport Systems, 2nd Edition

This document provides criteria to assist manufacturers and end users of transport devices in providing and selecting dependable products for the transport of microbiological clinical specimens.

This edition of the document was corrected in August 2015. Read the full correction notice here, and learn more about our corrections process here.

This document is available in electronic format only.

This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of September 2019. The document’s next scheduled review is generally five years after the reaffirmation date.

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Chairholder: Paul Bourbeau, PhD, D(ABMM) and Paul L. Cerwinka, MSc, RM(AAM)

Date of Publication: June 26, 2014

Order Code PDF: CLSI M40A2E
ISBN Number: 1-56238-964-5

Order Code Print: print not available

Edition: Second

Pages: 56

CLSI M40 Additional Details

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The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

CLSI M40 Abstract

Clinical and Laboratory Standards Institute document M40-A2—Quality Control of Microbiological Transport Systems; Approved Standard—Second Edition presents the criteria that shall be considered when choosing a microbiological transport device to facilitate sample preservation. QC considerations for the manufacturer and testing laboratory are presented, as well as techniques, control microorganisms, and acceptability criteria. This document provides a consistent protocol for initial testing of microbiological transport devices by manufacturers and a method by which laboratories can validate manufacturer claims and compare devices.