DIN EN 868-10:2019 pdf download.Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods. 4 Anforderungen 4.1 Allgemeines Für jegliche Materialien sowie jegliche vorgefertigte Sterilbarrieresysteme oder jegliche Sterilbarrieresysteme geiten die Anforderungen nach EN ISO 11607-1. Dieser Tell von EN 868 enthält lediglich Leistungsanforderungen und PrUfverfahren, die spezifisch für die Produkte...
BS EN ISO 11607-2:2006 pdf free
BS EN ISO 11607-2:2006 pdf free.Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes. Medical devices delivered in a sterile state should be designed, manufactured and packed to ensure that they are sterile when placed on the market and remain sterile, under documented storage and transport conditions, until the sterile barrier system...
BS EN ISO 11607-1:2017 pdf free
BS EN ISO 11607-1:2017 pdf free.Packaging for terminally sterilized medical devices -Part1:Requirements for materials, sterile barrier systems and packaging systems. ISO 11607 consists of the following parts, under the general title Packaging for terminally sterilized medical devices: — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Part 2: Validation requirements for forming, sealing and assembly processes...