Clinical and Laboratory Standards Institute document EP25-A--Evaluation of Stability of In Vitro Diagnostic Reagents;
Approved Guideline provides guidance and regression-based procedures for establishing stability-related claims of in vitro
diagnostic (IVD) reagents such as reagent kits, calibrators, control products, and sample diluents. This guideline was written
primarily for manufacturers and regulatory agencies, but will also be of interest to clinical laboratories. It provides information on
the design, implementation, data analysis, and documentation needs for studies to establish and verify shelf life and in-use life of
IVD reagents. Additional topics address assessment of product transport conditions on stability and accelerated stability testing.
| File Size : | 1
file
, 1.5 MB |
| ISBN(s) : | 1562387065 |
| Note : | This product is unavailable in Russia, Belarus |
| Number of Pages : | 56 |
| Published : | 09/01/2009 |
