CLSI EP22 P : 1ED 2010
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
PRESENTATION OF A MANUFACTURER'S RISK MITIGATION INFORMATION FOR USERS OF IN VITRO DIAGNOSTIC DEVICES
01-11-2010
12-01-2013
Abstract
Committee Membership
Foreword
Laboratory Failure Sources and CLSI Evaluation Protocols
Documents
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 An Overview of a Manufacturer's Risk Management and Control
6 Risk Mitigations and the Type of Error Conditions Being
Monitored or Controlled
7 Risk Information Summary: Information Regarding Risk
Mitigations and Recommended User Interventions Intended to
Prevent Production or Release of Incorrect Test Results
8 Postmarket Monitoring
References
Additional References
Appendix A - A Manufacturer's Risk Mitigation Information
Provided to Users: An Illustrative Example of a
Glucose Measurement on an Automated Analyzer
Appendix B - A Manufacturer's Risk Mitigation Information
Provided to the Users: Illustrative Example of
a Molecular Diagnostic Unit-Use Device
The Quality Management System Approach
Related CLSI Reference Materials
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