Sterilization of health care products -- Dry heat -- Requirements for the development, validation and routine control of a sterilization process for medical devices— 68 стр.
Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices— 12 стр.
Specification for radio disturbance and immunity measuring apparatus and methods. Methods of measurement of disturbances and immunity. Conducted disturbance measurements— 112 стр.
Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes -- Amendment 1— 8 стр.
Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems -- Amendment 1— 16 стр.
Sterilization of health care products -- Moist heat -- Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization— 58 стр.
Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices— 48 стр.
Sterilization of health care products -- Chemical indicators -- Part 4: Class 2 indicators as an alternative to the Bowie and Dicktype test for detection of steam penetration— 42 стр.
Sterilization of health care products -- Chemical indicators -- Part 3: Class 2 indicator systems for use in the Bowie and Dicktype steam penetration test— 28 стр.
Sterilization of health care products -- Biological indicators -- Part 5: Biological indicators for lowtemperature steam and formaldehyde sterilization processes— 12 стр.
Sterilization of health care products -- Radiation -- Part 1: Requirements For development, validation and routine control of a sterilization process for medical devices— 44 стр.
Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices— 88 стр.
Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous and plastic film construction. Requirements and test methods— 22 стр.
