EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 14708-4 testing. This standard specifies specific requirements for active implantable medical devices intended to deliver a medicinal substance to site-specific locations in the human body, in order to provide basic assurance of safety for both patients and users. It replaces and supplements ISO 14708-1. The requirements of this standard take precedence over the requirements of ISO 14708-1.
This standard applies to active implantable medical devices intended to deliver medicinal substances to site-specific locations in the human body.
The tests specified in this standard are type tests intended to be performed on a device sample to demonstrate conformity and are not intended to be used in routine testing of manufactured products.
This part of ISO 14708 specifies specific requirements for active implantable medical devices intended to deliver a medicinal substance to site-specific sites in the human body to provide basic assurance of safety for both patients and users. The requirements of this part of ISO 14708 take precedence over the requirements of ISO 14708-1.
An implantable infusion pump is a device that provides a constant flow rate or a variable flow rate in which a medicinal substance is delivered through an implanted catheter to site-specific locations in the human body. An external programmer can be used to set device parameters.
This part of ISO 14708 deals with all parts and accessories of implantable infusion pumps, including catheters, refill kits, direct access port kits, programmers and associated software.
Not all parts or accessories are intended to be implanted in whole or in part, but some requirements for non-implantable parts and accessories need to be specified if this could affect the safety or performance intended by the manufacturer.
EUROLAB assists manufacturers with ISO 14708-4 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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