To qualify their products for "exempt" status in the laboratory, manufacturers must:
Use the templates mentioned in Appendix B (once you access the PDF) or create your own that capture:
The CLSI M22-A3 document is available for purchase on the CLSI website ( www.clsi.org ). You can also search for the document on various online libraries or academic databases. However, I couldn't find a freely available PDF version of the document. clsi m22a3 pdf
A central concept of CLSI M22-A3 is the division of quality control obligations.
Outlining clear criteria for what user laboratories must still test upon receipt. To qualify their products for "exempt" status in
Provides the M22-A3 PDF with Digital Rights Management (DRM) protection.
: It serves as a guide for both manufacturers producing media and clinical laboratories using it. Media Types A central concept of CLSI M22-A3 is the
The primary objective of the document is to establish uniform quality control parameters while reducing unnecessary, repetitive testing in clinical laboratories. It outlines which media require full user verification and which can be accepted based on the manufacturer’s quality assurance certification. Key Components of the Standard
Direct access to the M22 Standard and updates.
Test for using negative control organisms that should be inhibited.