EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN ISO 25424 testing. This standard specifies requirements for the development, validation and routine control of the low temperature steam and formaldehyde (LTSF) sterilization process for medical devices that use a mixture of low temperature steam and formaldehyde as the sterilizing agent and operate below ambient pressure.
While the scope of this document is limited to medical devices, it specifies requirements and provides guidance that can be applied to other products and equipment.
This document does not specify requirements for the development, validation, and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy, and Creutzfeldt-Jakob disease. Specific recommendations have been made in certain countries for the handling of materials potentially contaminated with these agents.
Having a complete quality management system during manufacture or rework is not a requirement of this document, but the essential elements of such a system are normatively referenced in the text where appropriate. Attention is drawn to quality management systems standards that control all production or reprocessing stages of medical devices, including the sterilization process.
Attention is drawn to the possible existence in some countries of legal regulations that set limits for the level of formaldehyde residues on medical devices and products.
EUROLAB assists manufacturers with EN ISO 25424 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
