ISO 15198:2004
Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
ISO 15198:2004 describes a process for manufacturers of in vitro diagnostic medical devices to validate quality control procedures they recommend to their users. These quality control procedures are intended to provide users with assurance that device performance is consistent with its intended use and the manufacturers' claims. ISO 15198:2004 applies to all in vitro diagnostic medical devices.
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TitlePage - Clinical laboratory medicine—
Foreword - Foreword
Introduction - Introduction
Scope - 1 Scope
NormativeReference - 2 Normative references
Clause1 - 4 Quality control procedures
Subclause2 - 4.1 General
Subclause2 - 4.2 Risk analysis
Subclause2 - 4.3 Performance evaluation studies
Clause1 - 5 Validation of quality control procedures
Subclause2 - 5.1 General
Subclause2 - 5.2 Applicability
Subclause2 - 5.3 Validation
Subclause3 - 5.3.1 Validation planning
Subclause3 - 5.3.2 Validation responsibility
Subclause3 - 5.3.3 Validation protocol
Subclause2 - 5.4 Validation studies
Subclause2 - 5.5 Validation report
Subclause2 - 5.6 Revalidation
Clause1 - 6 Recommendations to users
Bibliography - Bibliography
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BS EN 13532:2002
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TitlePage - Clinical laboratory medicine—
Foreword - Foreword
Introduction - Introduction
Scope - 1 Scope
NormativeReference - 2 Normative references
Clause1 - 4 Quality control procedures
Subclause2 - 4.1 General
Subclause2 - 4.2 Risk analysis
Subclause2 - 4.3 Performance evaluation studies
Clause1 - 5 Validation of quality control procedures
Subclause2 - 5.1 General
Subclause2 - 5.2 Applicability
Subclause2 - 5.3 Validation
Subclause3 - 5.3.1 Validation planning
Subclause3 - 5.3.2 Validation responsibility
Subclause3 - 5.3.3 Validation protocol
Subclause2 - 5.4 Validation studies
Subclause2 - 5.5 Validation report
Subclause2 - 5.6 Revalidation
Clause1 - 6 Recommendations to users
Bibliography - Bibliography