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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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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
Describes guidance for establishing shelf-life and in-use stability claims for in vitro diagnostic method products such as reagent kits, calibrators, and control products.
| DocumentType |
Proposed Guideline
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| PublisherName |
Clinical Laboratory Standards Institute
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| Status |
Superseded
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| SupersededBy |
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