Historical
ONORM EN ISO 11607-1:2018
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006, including Amd 1:2014)
This part of ISO 11607 sets the requirements and test methods for materials, sterile barrier systems and pre made sterile barrier systems and packaging systems, which are intended to the sterility in the final packaging to be sterilized the Medical devices to the application time to maintain. This part of ISO 11607 applies to the industry for health care facilities and all other facilities where medical devices in sterile barrier systems are packaged and sterilized. This part of ISO 11607 collects not all requirements for sterile barrier systems and packaging systems for aseptic medical products. For combinations of medicinal products and medical devices, additional requirements may be necessary. This part of ISO 11607 describes no quality assurance system for the management of all manufacturing steps. This part of ISO 11607 does not apply to packaging materials or systems that are used...
Austrian Standards Institute [on]