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Cormica Releases In-Depth Article on Updated ISO 18562 Standard
The long-awaited update to the ISO 18562 standard for biocompatibility evaluation of breathing medical gas pathways is here! Medical Engineering Technologies (MET) is pleased to announce that our experts Luminita Moraru & Elena Henderson have published a detailed article on the changes and their implications for manufacturers and testing labs.
Key Changes in the Update
- Expanded terminology offers clearer definitions.
- Revised risk assessment process improves efficiency and accuracy.
- Focus on Volatile Organic Substances (VOS) rather than just VOCs.
- New considerations for particulate matter and leachables ensure comprehensive safety.
Why Does This Matter?
Understanding these changes is crucial for manufacturers wanting to prove device biocompatibility. These updates significantly impact testing requirements, so getting up-to-speed is essential.
Read Cormica's article for a comprehensive breakdown and insights: ISO 18562: 2024 Updates
MET is Ready to Help!
Our team is fully updated on the ISO 18562 revisions. If you need assistance with biocompatibility testing for your gas pathway device, don't hesitate to contact us on sales@cormica.com
