CLSI EP22 P : 1ED 2010

Name: CLSI EP22 P : 1ED 2010
Brand: CLSI

Withdrawn

PRESENTATION OF A MANUFACTURER'S RISK MITIGATION INFORMATION FOR USERS OF IN VITRO DIAGNOSTIC DEVICES

Withdrawn date

11-01-2010

Published date

01-12-2013

Publisher

Clinical Laboratory Standards Institute

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

Specifies guidance to manufacturers on the establishment and disclosure of information they might choose to share with users regarding the scope and effectiveness of risk mitigation features and recommended user interventions intended to prevent the production or release of incorrect patient test results.

DocumentType	Proposed Guideline
PublisherName	Clinical Laboratory Standards Institute
Status	Withdrawn

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