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How to Perform Cleaning Validations for Non-Critical Devices According to the New ANSI/AAMI ST98 Standard

Cleaning validation requirements for reusable medical devices according to AAMI TIR30 did not distinguish between non-critical devices on the one hand and semi-critical or critical devices on the other. Only general recommendations were formulated, which resulted in one validation approach being applied to all types of medical devices, regardless of contamination and patient risk. Now that AAMI TIR30 has recently been replaced by ANSI/AAMI ST98, specific exemptions are mentioned for non-critical devices. According to ANSI/AAMI ST98 non-critical devices are generally allowed to be tested using a less rigorous approach as compared to semi-critical or critical devices. These changes are summarized in the infographic below.

One particular challenge reusable medical device manufacturers will be facing is the determination of an appropriate sample size for testing. Our Expert Advisory Services team can help you perform sample size justifications, leveraging our experience in validation testing and knowledge of how device complexity relates to cleanability.


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Katleen Peymen, PhD

Study Director Healthcare reprocessing and Microbiology

Katleen Peymen received her PhD in Biochemistry and Biotechnology from the Faculty of Science at the University of Leuven (Belgium) in 2019. After her career as a post-doctoral researcher, she started at Nelson Labs Europe in 2020 as a Study Director for Healthcare reprocessing and Microbiology. She is responsible for the study design, analysis and reporting of healthcare reprocessing validations for reusable medical devices, such as cleaning, disinfection, and steam sterilization validations, and is an active member of several International Organization for Standardization (ISO) committees related to healthcare reprocessing.