New Standard from Last Update.

1. SCOPE

1.1 This standard describes the specifications and standard testing procedure, for determining the performance of In–vitro Diagnostics (IVD) clinical chemistry reagents/kits, used for the estimation of a-Amylase in human serum or plasma, based on the CNP-G3 method.

1.2 This test method is recommended for all forms of a-Amylase (CNP-G3), liquid stable clinical chemistry reagents/kits except those used in dry chemistry analyzers and closed fully automated chemistry analysers.