PRINCIPLES OF SAFETY AND PERFORMANCE FOR MEDICAL HYPERBARIC CHAMBERS: GUIDELINES FOR REGULATORY SUBMISSION
American Society of Mechanical Engineers
Foreword
Abstract
1 Scope
2 Device Description
3 General Safety Information
4 Essential Principles and Evidence of Conformity
5 Summary of Design Verification and Validation
6 Clinical Evidence
7 Labeling
8 Risk Analysis
9 Manufacturer Information
Acknowledgements
Abbreviations and Acronyms
Gives guidance for completing such regulatory submissions as well as principles of safety and performance of Pressure Vessels for Human Occupancy intended for use as medical devices.
| Document Type | Standard |
| Status | Current |
| Publisher | American Society of Mechanical Engineers |
