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Principles of Safety and Performance for Medical Hyperbaric Chambers: Guidelines for Regulatory Submission 医用高压舱的安全和性能原则:监管提交指南
发布日期: 2011-06-30
本文件为涉及高压舱的监管提交文件的制定、审查和批准提供了指导,并审查了拟用作医疗设备的载人压力容器(PVHO)的安全和性能原则。
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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发布单位或类别: 美国-美国机械工程师协会
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