The ASTM F2559/F2559M-21 Standard Guide provides specifications and requirements for sterilizable medical apparatus disbonding bags. The guide covers the manufacture, purchase, and acceptance of prefabricated sterile barrier systems, including material selection and basic design requirements for bags. Whether herringbone, header, or angular disbonding type, these bags must be able to effectively protect and contain equipment while remaining sterile during handling. The guide also supports material and Encasement testing consistent with standards such as ISO 11607-1 and ISO 11607-2. All requirements should be jointly confirmed by the supplier and purchaser to ensure bag compliance.
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