EN ISO 8536-4 Infusion Equipment for Medical Use, Part 4: Disposable Infusion Sets, Standard Test for Gravity Feeding

Medical Device Tests

EN ISO 8536-4 Infusion Equipment for Medical Use, Part 4: Disposable Infusion Sets, Standard Test for Gravity Feeding

EUROLAB laboratory provides testing and compliance services within the scope of EN ISO 8536-4 standard. This standard specifies requirements for disposable, gravity-fed infusion sets for medical use to ensure their compatibility with containers for infusion solutions and intravenous equipment.

EN ISO 8536-4 Infusion Equipment for Medical Use, Part 4: Disposable Infusion Sets, Standard Test for Gravity Feeding

The secondary purposes of this standard are to provide guidance on the specifications regarding the quality and performance of materials used in infusion sets and to provide definitions of infusion set components.

The infusion set must be equipped with protective caps to maintain the sterility of the internal parts of the set until the set is used. The air inlet device must have a protective cover over the closing puncture device or needle.

The flow regulator will adjust the flow of the infusion solution between zero and maximum. The flow regulator must be able to be used continuously throughout the infusion without damaging the tubing. There should be no harmful reaction between the flow regulator and the pipe when stored in contact.

EUROLAB assists manufacturers with EN ISO 8536-4 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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