17/30359001 DC : 0
NA
Status of Standard is Unknown
BS ISO/IEC GUIDE 63 - GUIDE TO THE DEVELOPMENT AND INCLUSION OF ASPECTS OF SAFETY IN INTERNATIONAL STANDARDS FOR MEDICAL DEVICES
Hardcopy , PDF
English
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
BS ISO/IEC Guide 63.
| Committee |
CH/210/4
|
| DocumentType |
Draft
|
| Pages |
35
|
| PublisherName |
British Standards Institution
|
| Status |
NA
|
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