Cleaning Method Validation for Medical Devices | ASTM Standardization News


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A proposed ASTM International standard presents methods for detecting and quantifying cleaning markers (analytes) on reusable medical devices. ASTM’s committee on medical and surgical materials and devices (F04) is developing the proposed standard.

The objective of the proposed standard (WK63284) would help medical device manufacturers, testing laboratories, and regulatory bodies identify the appropriate method(s) for evaluating whether a medical device can be adequately cleaned. The committee is developing a series of guides for validating cleaning instructions for medical devices.

“The proposed standard would be helpful in determining the quantitative test methods for accurately determining the analyte concentration in clinically relevant soils,” says ASTM International member Kaumudi Kulkarni of Healthmark Industries Co.

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