English
Français
Deutsch
Nederlands
In the field of sterile medical device packaging, EN ISO 11607-1 serves as the fundamental technical requirement for the design and performance of packaging systems. The standard specifies that all sterile barrier systems (SBS) must maintain sterility from the point of sterilization until the point of use. It applies to both single and double packaging configurations, covering the full packaging lifecycle: storage, transportation, sterilization, and aseptic opening.
At Hopeway AMD, we implement EN ISO 11607-1 through a rigorous selection of materials and structural design strategies. Our AMD products are manufactured using high-standard medical grade paper,DupontTM Tyvek®, approved multilayer films to form well-defined SBS.
All materials undergo validation for microbial barrier properties, tensile strength, material compatibility, and clean peel characteristics. We routinely conduct accelerated aging, burst strength, and seal integrity testing in accordance with Annex B and C of the standard.
Key Products:
- AMD Packaging made of Tyvek®(compatible with ETO, Steam, and Gamma)
- AMD Sterilization Reel and Pouch
By aligning with EN ISO 11607-1, Hopeway AMD helps medical device manufacturers establish a reliable and compliant sterile packaging system that supports global regulatory approval processes.
‘s-Gravenweg 542, 3065SG RotterdamThe Netherlands
+31 (0)10 254 28 08
