CLSI I/LA33 A : 1ED 2009

Withdrawn

Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

VALIDATION OF AUTOMATED SYSTEMS FOR IMMUNOHEMATOLOGICAL TESTING BEFORE IMPLEMENTATION

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Withdrawn date: 28-03-2016

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Published date: 12-01-2013

Publisher: Clinical Laboratory Standards Institute

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Abstract
Committee Membership
Foreword
1 Scope
2 Standard Precautions
3 Terminology
4 Immunohematology Tests and Automated Systems
5 Validation Process
6 Materials (Reagents, Equipment, and Supplies)
7 Installation Qualification
8 Operational Qualification
9 Performance Qualification
References
Appendix - Sample Templates and Test Cases
Summary of Delegate Comments and Subcommittee Responses
The Quality Management System Approach
Related CLSI Reference Materials

Abstract - (Show below) - (Hide below)

Specifies guidance to the end user and laboratory for validation of automated systems used in immunohematological testing before implementation.

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Development Note	Supersedes NCCLS I/LA33 P. (04/2010)
Document Type	Miscellaneous Product
ISBN
Pages
Published
Publisher	Clinical Laboratory Standards Institute
Status	Withdrawn
Supersedes	CLSI I/LA33 P : 1ED 2009

Standards Referenced By This Book - (Show below) - (Hide below)

DIN EN ISO 15189:2014-11	Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)

Standards Referencing This Book - (Show below) - (Hide below)

CLSI EP14 A2 : 2ED 2005	EVALUATION OF MATRIX EFFECTS
CLSI H57 A : 1ED 2008	PROTOCOL FOR THE EVALUATION, VALIDATION, AND IMPLEMENTATION OF COAGULOMETERS
CLSI M29 A3 : 3ED 2005	ACQUIRED INFECTIONS; APPROVED GUIDELINE
CLSI EP7 A2 : 2ED 2005	INTERFERENCE TESTING IN CLINICAL CHEMISTRY
CLSI AUTO8 A : 1ED 2006	MANAGING AND VALIDATING LABORATORY INFORMATION SYSTEMS
CLSI QMS03 A3 : 3ED 2009	TRAINING AND COMPETENCE ASSESSMENT
CLSI GP2 A5 : 5ED 2006	LABORATORY DOCUMENTS - DEVELOPMENT AND CONTROL
CLSI EP18 A2 : 2ED 2009	RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES

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