ISO 8536-14 Test for Medical Use Infusion Equipment

Medical Device Tests

ISO 8536-14 Test for Medical Use Infusion Equipment

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 8536-14 testing. This standard specifies requirements for non-sterile clamps and flow regulators used as a subcomponent to control the flow of intravenous solutions or blood components through sterilized infusion and blood transfusion sets and blood bag assemblies without liquid contact.

ISO 8536-14 Test for Medical Use Infusion Equipment

Infusion therapy is an alternative to oral therapy that requires administration of drugs or medication through a sterile catheter or needle. These are usually given into a patient's vein and reassured by a professional healthcare provider. This treatment option has been used by hospitals for a long time.

Increasingly, infusion therapy is administered in outpatient healthcare settings and community care centers by specialist nurses who are professionally trained to perform this procedure.

Infusion therapy is mainly used to treat serious or chronic diseases and infections that do not respond to oral antibiotics. There are many instances of disease conditions and infections that are consistently treated using infusion therapy. This includes different types of cancer, gastrointestinal tract infections, Crohn's disease, ulcerative colitis and inflammatory bowel disease.

In some countries, national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-14:2016.

EUROLAB assists manufacturers with ISO 8536-14 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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