Foreword
Introduction
1 Scope and objective
2 Terms and definitions
3 Use of the terms 'safety', 'safe', 'effective',
and 'effectiveness'
4 Principles for including aspects of safety in
medical device standards
5 The nature of risk
6 Risk-based process for developing a medical
device standard that include aspects of safety
7 Overview of the application of medical device
standards including aspects of safety in a
risk management framework
Annex A (informative) - Product and process
safety standards
Annex B (informative) - Risk information
Bibliography