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CGA M-19:2023

Current

Current

The latest, up-to-date edition.

Standard for Biocompatibility of Materials for Medical Gas Equipment

Available format(s)

Hardcopy

Language(s)

English

Published date

10-03-2023

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.

DocumentType
Standard
Pages
4
PublisherName
Compressed Gas Association
Status
Current
Supersedes

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$42.69
Including GST where applicable

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