This document provides guidance with development, review and approval of regulatory submissions involving hyperbaric chambers and reviews the principles of safety and performance of Pressure Vessels for Human Occupancy (PVHO) intended for use as medical devices.
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| ASME | |
|---|---|
| Product Category | Standards and Technical Documents |
| Product Number | STP-PT-047 - 2011 |
| Product Name | STP-PT-047 - Principles of Safety and Performance for Medical Hyperbaric Chambers: Guidelines for Regulatory Submission |
