Publication

M-19: Standard for Biocompatibility of Materials for Medical Gas Equipment

Abstract

This publication applies to medical devices that come into direct or indirect contact with the human body and are subject to Premarket Application (PMA) and Premarket Notification (510(k)) requests in order to determine potential toxicity. This publication may be used for evaluation of other medical devices.

This publication addresses high and low pressure gas systems. It applies to both metallic and nonmetallic materials including lubricants, ceramics, and glass that contact the caregiver or the patient using the medical device. Contact can include direct contact with the material or contamination of the gas stream with potentially toxic materials. The gas stream can be contaminated through contact with a wetted component or through a reaction of the gas with an internal component of the medical device. See CGA G-4.10, Use of Nonmetallic Materials in High Pressure Oxygen Breathing Gas Applications for use of nonmetallic materials in oxygen as it relates to ignition.

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Properties

Edition:
2
Published:
March 2023
Status:
Available To the Public
Size:
4 pages
Publisher:
CGA
Special Attributes:
Notes:
Committee:
Medical Equipment

Cataloging

Category
Medical Gases     Standards & Guidelines
Keywords
medical gases
Related
G-4.10  |  TR-3