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CLSI EP25 P : 1ED 2008

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

Superseded date

23-09-2009

Superseded by

CLSI EP25 A : 1ED 2009

Published date

12-01-2013

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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
PublisherName
Clinical Laboratory Standards Institute
Status
Superseded
SupersededBy

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