EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 8536-1 testing. ISO 8536-1 specifies the dimensions, performance and requirements for infusion glass vials necessary to achieve functional interchangeability. Applies to disposable infusion bottles only.
Infusion bottles are the primary packaging materials suitable for storing infusion solutions until they are administered to the patient. Due to the direct contact between the infusion solution and the primary container components, and given the long storage times, it is important to avoid potential interactions to ensure patient safety. Adequate means to achieve this goal include the correct selection of primary packaging materials, the selection of appropriate packaging design, and the availability of specific criteria and methods for testing individual container systems.
An infusion glass bottle for medical use that complies with the requirements set forth in this section of ISO 8536 is identified using the identifier "Infusion bottle" followed by the infusion pattern reference to this part of ISO 8536 in the order given.
Seed or bubbles, sealing surface, etc. of infusion bottles. performance requirements must comply with existing quality standards, e.g. defect rubrics and to be agreed between the manufacturer and the user.
The number of parts and the standard identification should be shown on the packaging along with the name or symbol of the infusion bottle manufacturer. Other statements may be included at the manufacturer's discretion or by agreement between the user and the manufacturer.
EUROLAB assists manufacturers with ISO 8536-1 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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