Standard for Biocompatibility of Materials for Medical Gas Equipment

Available format(s)

Hardcopy

Language(s)

English

Published date

10-03-2023

Publisher

Compressed Gas Association

1.Introduction
2.Scope
3.Definitions
4.Biocompatibility of materials
Chemical characteristics
Nature and degree of contact
Biocompatibility testing
Medical gas biocompatibility
5.Requirements
Risk analysis
Specific requirements
6.References

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.

DocumentType	Standard
Pages	4
PublisherName	Compressed Gas Association
Status	Current
Supersedes	CGA M 19 : 2017

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CGA M-19:2023

Standard for Biocompatibility of Materials for Medical Gas Equipment

Table of Contents

Abstract

General Product Information

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