ISO 11607

ISO 11607 Packaging for Terminally Sterilized Medical Devices - Medical Device Package Validation

ISO 11607 is the principal guidance document for validating terminally sterilized medical device packaging systems, the guidlines of package performance testing, accelerated aging, material evaluation and sterile integrity testing. ISO 11607 is also a FDA Recognized Consensus Standard.

As an expert manufacturer of testing equipment for flexible packaging, Labthink also have some equipment to conduct the package integrity and strength test according to ISO 11607:

• ASTM F88 -- Package Seal Strength Testing by Seal Peel Testing
• ASTM D3330 -- Package Seal Strength Testing by Peel Adhesion Testing
• ASTM F2054 --  Package Seal Strength Testing by Crepp Testing
• ASTM F1140 -- Package Seal Strength Testing by Burst Testing
• ASTM F2096 -- Package Integrity Testing by Bubble Test (Using LSSD-01 with customized fixture)