Coronati Consulting announces the withdrawal of ISO 14698 standards
Adopts the EN 17141:2020 standard as the main reference, with ISO/IEC 17025 certification. Offers consulting for customized protocols.
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Laboratory testing and consultancy for medical devices
coronaticonsulting.itLast updated
In short: Coronati Consulting expanded its laboratory accreditations, updated compliance standards, and achieved certification for gender equality.
Adopts the EN 17141:2020 standard as the main reference, with ISO/IEC 17025 certification. Offers consulting for customized protocols.
The accreditation concerns the test for contaminant particulate to evaluate the cleanliness of medical devices, in compliance with MDR and ISO 10993-1:2021. Extendable to other devices.
New tests accredit microbiological controls in air and surfaces for cleanroom according to EN 17141 and USP-NF, and particle counting on medical devices.
The updates include revisions to the UNI EN ISO 10993-5:2025 standard for in vitro cytotoxicity tests, USP-NF 2025 for sterility and bacterial endotoxins. The certificates are on the website.
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