1. Understanding the type of medical device

This test is only applicable for reusable medical devices. Devices are categorized as:

• Critical: Devices that come into contact with sterile body tissues or fluids.
• Semi-critical: Devices that contact mucous membranes or non-intact skin.
• Non-critical: Devices that only touch intact skin.

2. Select the appropriate soiling

The test soil depends on the type of medical device being validated. We can help to determine the appropriate test soils and soiling methods based on the device’s intended use and worst-case conditions.

By default, our lab uses test soils with

• protein
• hemoglobin

However, other soiling options may be considered based on device-specific requirements.

3. Define the cleaning procedure

Currently, only manual cleaning validation is covered, as this process can have significant variability. The manufacturer must determine:

• The detergent to be used (e.g., enzymatic or alkaline cleaner).
• The soaking time and rinsing cycles.
• Whether brushing is required during the cleaning process.

4. Establish the passing criteria

In addition to visual inspection, quantitative measurements will be performed. The AAMI ST98 standard defines acceptance criteria for key markers to ensure the effectiveness of the manufacturer’s cleaning process.