CGA M-19:2023
Current
The latest, up-to-date edition.
Standard for Biocompatibility of Materials for Medical Gas Equipment
Hardcopy
English
10-03-2023
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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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