This European Standard specifies information to be provided to users and third-party verifiers regarding manufacturing and processing requirements, in addition to the usual labeling of medical devices.
This European Standard provides information on the characteristics of disposable and reusable fresh air clothing used as medical devices for clinical staff, aimed at preventing the transmission of infective agents between clinical staff and patients during surgical and other invasive procedures.
This European Standard specifies test methods for evaluating defined properties of clean air clothing and lays out the performance requirements for these products.
An understanding of the causes of the main requirements is considered essential for its correct implementation. It is also believed that as clinical practices and technologies change, the rationale for current requirements will facilitate any revision of this document required by these developments.
EUROLAB assists manufacturers with EN 13795-2 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.
