Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes -- Amendment 1— 8 стр.
Sterilization of health care products. Ethylene oxide. Requirements for development, validation and routine control of a sterilization process for medical devices— 54 стр.
Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes -- Amendment 1— 8 стр.
Medical electrical equipment. Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery— 32 стр.
Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices— 50 стр.
Packaging for terminally sterilized medical devices. Adhesive coated paper for low temperature sterilization processes. Requirements and test methods— 26 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— 20 стр.
Medical electrical equipment. Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery— 34 стр.
Packaging for terminally sterilized medical devices. Re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods— 22 стр.
Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous and plastic film construction. Requirements and test methods— 22 стр.
Medical electrical equipment. Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery— 30 стр.
Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment. General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels— 24 стр.
Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery (IEC 80601-2-58:2008) (english version)
Medical electrical equipment -- Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery (IEC 80601-2-58:2014) (english version)
