EUROLAB laboratory provides testing and compliance services within the scope of ASTM F2559 test standard. ASTM F2559 aims to define requirements for flexible peel-off bags intended to be sterilized for the storage of medical devices.
Bags must have an open, unsealed end. They are also known as preformed sterile barrier systems.
For this test, peel bags are categorized as chevrons, caps, and corner shells. Bags are usually made by heat sealing or adhesive cold sealing. Either way, it's the seal that needs to be peeled off. The bag can be porous, non-porous or combined, but must meet the printing requirements specified in the standard.
ASTM F2559 allows instructions or a specification to be written. Specification materials are required to address manufacturing method, physical properties, performance requirements, sizing, appearance, and printing.
Peel bags are used universally by the medical device industry and are required to maintain their sterility during physical use, regardless of manufacturer or material.
Bag requirements are divided into "starter bag and material adequacy" and "routine production and pickup requirements". In most cases, initial bag testing is only required before the first order to ensure the product meets the standards. Routine production requirements must be followed for each order to ensure the customer receives the appropriate product.
This standard does not purport to address all, if any, safety concerns associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health and environmental practices and to determine the applicability of regulatory restrictions prior to use.
EUROLAB assists manufacturers with ASTM F2559 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.
