CLSI EP25 A : 1ED 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 REAGENTS
Hardcopy , PDF
English
23-09-2009
13-05-2023
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
Appendix C - Determining the Number of Time Points and
Repeats of Stability Studies Based on Linear
Regression Analysis
Summary of Comments and Subcommittee Responses
Laboratory Failure Sources and CLSI Evaluation Protocols
Documents
The Quality Management System Approach
Related CLSI Reference Materials
Gives guidance for establishing shelf-life and in-use stability claims for in vitro diagnostic reagents such as reagent kits, calibrators, and control products.
| DevelopmentNote |
Supersedes NCCLS EP25 P. (01/2010)
|
| DocumentType |
Standard
|
| ISBN |
1-56238-706-5
|
| Pages |
52
|
| PublisherName |
Clinical Laboratory Standards Institute
|
| Status |
Superseded
|
| SupersededBy |
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