CGA M-19:2023

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.