Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principles, data concepts and process model
5 Patient safety data elements
Annex A (informative) - Information on various health
        software surveillance systems
Bibliography

Abstract

Gives a model framework for improving the surveillance and reporting of events with respect to the safety of health software.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 215