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 868-9. Packaging for terminally sterilized medical devices. Part 9. Uncoated nonwoven materials of polyolefines. Requirements and test methods— 11 стр.
BS EN 868-10. Packaging for terminally sterilized medical devices. Part 10. Adhesive coated nonwoven materials of polyolefines. Requirements and test methods— 15 стр.
BS EN ISO 14160. Sterilization of health care products. Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives. Requirements for characterization, development, validation and routine control of a sterilization process for medical devices— 48 стр.
BS EN ISO 10993-9. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products— 23 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.
Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices— 72 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.
BS EN ISO 10993-15. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys— 26 стр.
