Table of Contents

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

Abstract

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.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	American Society of Mechanical Engineers
Pages
ISBN