CLSI EP25 P : 1ED 2008
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC METHOD PRODUCTS
09-23-2009
01-12-2013
Abstract
Committee Membership
Foreword
1 Scope
2 Standard Precautions
3 Terminology
4 Overview of the Stability Testing Process
5 Real-time Stability Study Protocol
6 Real-time Stability Monitoring (Verification)
7 Accelerated Stability Testing
References
Appendix A - Measurand Drift Analysis Example
Appendix B - Example of Use of Arrhenius Equation With
Accelerated Stability Testing Data to Predict
Shelf Life of an In Vitro Diagnostic Control
Product
The Quality Management System Approach
Related CLSI Reference Materials
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.