ASME STP-PT-047 : 2011
Current
The latest, up-to-date edition.
PRINCIPLES OF SAFETY AND PERFORMANCE FOR MEDICAL HYPERBARIC CHAMBERS: GUIDELINES FOR REGULATORY SUBMISSION
English
30-06-2011
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
This document applies to hyperbaric chambers intended for use as medical devices for the clinical treatment of various diseases and conditions.
| DocumentType |
Standard
|
| ISBN |
9780791833681
|
| Pages |
22
|
| PublisherName |
American Society of Mechanical Engineers
|
| Status |
Current
|
| ASME PVHO 1 : 2016 | SAFETY STANDARD FOR PRESSURE VESSELS FOR HUMAN OCCUPANCY |
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