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
Hardcopy , PDF
English
06-30-2011
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
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