Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principles of nucleic acid based in vitro
  diagnostic examinations
5 Performance characteristics
6 Risk management
Bibliography

Abstract

Applies to IVD medical device manufacturers, medical laboratories, and research and development laboratories that develop nucleic acid-based qualitative in vitro diagnostic examination procedures for the detection and identification of microbial pathogens in human specimens, and medical laboratories that perform nucleic acid-based in vitro diagnostic examinations for the detection and identification of microbial pathogens in human specimens.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 212