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Author: Katleen Peymen





May 2, 2024

Capacity Enhancements in our Healthcare Reprocessing Lab in Leuven, Belgium

Many good things are happening within our Healthcare Processing Team at our facility in Leuven, Belgium (GLP certified and ISO17025 accredited). Over the past year, we’ve experienced a notable uptick in test requests from medical device manufacturers. This surge has...

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June 30, 2023

Nelson Labs Europe announces Expansion of ISO 17025 Accreditation for Healthcare Reprocessing

Nelson Labs Europe is pleased to announce that we have recently expanded our ISO17025 accreditation for our healthcare reprocessing services. Reusable medical devices must be properly cleaned, disinfected, and/or sterilized. One of the services that Nelson Labs offers is to...

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June 13, 2023

How to perform cleaning validations for semi-critical and 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. Additionally, many validation testing requirements were formulated using generalities rather than...

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May 30, 2023

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...

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September 14, 2022

Are You Ready for the New ANSI/AAMI Standard, ST98, Regarding How to Perform Cleaning Validations for Health-Care Products?

Reusable medical devices need to have validated cleaning instructions to ensure patient safety and minimize health-care-acquired infections, corrective actions, recalls, and to ensure compliance with current regulatory standards. For devices that need to comply with US FDA, the requirements regarding...

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