EUROLAB laboratory provides testing and compliance services within the scope of EN ISO 1135-4 standard. ISO 1135-4 specifies requirements for disposable transfusion gravity sets for medical use to ensure their compatibility with containers for blood and blood components and with intravenous equipment.
The secondary purposes of ISO 1135-4 are to provide guidance on specifications regarding the quality and performance of materials used in transfusion sets, to provide definitions for transfusion set components, and to ensure compatibility of sets with a range of cellular and plasma.
In some countries, national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-4.
The cap-piercing device must be able to puncture and penetrate a container for blood and blood components without pre-punching the lid. Coring should not be done during this process.
Pipework made of flexible material must be transparent or sufficiently translucent so that the air-water interface can be observed with normal or corrected normal vision during the passage of air bubbles.
Tubing from the distal end to the drip chamber should not be less than 1500 mm, including the injection site and male taper connection, when provided.
EUROLAB assists manufacturers with EN ISO 1135-4 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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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.
