EUROLAB, together with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 22442 testing. This standard applies to medical devices other than in vitro. It covers medical diagnostic devices manufactured using materials of animal origin that have been rendered non-living or non-viable.
In conjunction with ISO 14971, it specifies a procedure for identifying hazards and hazardous situations associated with such devices, anticipating and evaluating emerging risks, controlling those risks, and monitoring the effectiveness of that control.
It also outlines the decision process for residual risk acceptability, taking into account the balance of residual risk and expected medical benefit compared to available alternatives, as defined in ISO 14971. This standard aims to provide requirements and guidance on risk management related to hazards specific to medical devices manufactured using animal tissues or derivatives such as:
Similar principles may apply for parasites and other unclassified pathogenic entities. This standard does not specify a quality management system for the control of all stages of the production of medical devices. This standard does not cover the use of human tissues in medical devices.
Having a complete quality management system during manufacturing is not a requirement of this standard. However, attention is drawn to international standards for quality management systems that control all stages of production or reprocessing of medical devices.
EUROLAB assists manufacturers with ISO 22442 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.
