AAMI advice on Class 6 indicators.

Area of Science:

• Medical Device Sterilization
• Chemical Indicators

Background:

• Class 6 emulating indicators (CIs) are process indicators designed to react to specific critical parameters of a sterilization cycle.
• Their application is crucial for ensuring the efficacy of sterilization processes, particularly for non-implantable medical devices.

Purpose of the Study:

• To outline the applications and proper usage of Class 6 emulating indicators in sterilization monitoring.
• To highlight their role in routine efficacy monitoring and qualification testing.

Main Methods:

• Class 6 CIs can function as internal chemical indicators within loads.
• They can also be integrated into Process Delivery Containers (PCDs) for comprehensive monitoring.
• For product testing, Class 6 CIs can be placed alongside Biological Indicators (BIs) within the product.

Main Results:

• Class 6 CIs are suitable for releasing non-implant loads when used appropriately.
• They can be employed in BI PCDs for routine sterilizer efficacy monitoring and qualification testing.
• Proper labeling of Class 6 CIs/CI PCDs for the specific cycle being monitored is essential for accurate results.

Conclusions:

• Class 6 emulating indicators offer a reliable method for monitoring sterilization processes.
• Their versatility allows for use in various scenarios, from internal load monitoring to PCDs and product testing.
• Adherence to labeling requirements ensures the integrity and validity of sterilization monitoring data.