Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous and plastic film construction. Requirements and test methods— 22 стр.
Sterilization of health care products. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices— 52 стр.
Packaging for terminally sterilized medical devices. Adhesive coated paper for low temperature sterilization processes. Requirements and test methods— 28 стр.
Packaging for terminally sterilized medical devices. Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5). Requirements and test methods— 22 стр.
Packaging materials and systems for medical devices which are to be sterilized. Heat and self-sealable pouches and reels of paper and plastic film construction. Requirements and test methods— 12 стр.
Packaging materials and systems for medical devices which are to be sterilized. Heat and self-sealable pouches and reels of paper and plastic film construction. Requirements and test methods— 12 стр.
BS EN ISO 11607-1. Packaging for terminally sterilized medical devices. Part 1. Requirements for materials, sterile barrier systems and packaging systems— 55 стр.
BS EN ISO 11607-2. Packaging for terminally sterilized medical devices. Part 2. Validation requirements for forming, sealing and assembly processes— 29 стр.
Sterilization of health care products. Moist heat. Guidance on the designation of a medical device to a product family and processing category for steam sterilization— 60 стр.
Packaging for terminally sterilized medical devices, Sealable pouches and reels of porous materials and plastic film construction. Requirements and test methods— 24 стр.