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