Attention Medical Device Professionals!
Staying ahead of the curve in regulatory standards is crucial. This March 2024 update to the ISO 18562 series for respiratory medical devices impacts your work!
Here's a quick breakdown of the key changes:
Broader Compound Analysis:
The new standards require a more comprehensive evaluation of potential compounds used in your devices.
Expanded Patient Group:
The revised standard considers a wider range of patient profiles for risk assessment.
Adjusted Toxicological Threshold:
The acceptable level of potential harm from device components has been reevaluated.
Continuous Assessment:
A new emphasis on ongoing evaluation of device performance, aging effects, and compatibility with cleaning/disinfection processes.
Ready to ensure your devices meet the latest regulations? We can help!