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.
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.
Acoustics -- Determination of sound power levels and sound energy levels of noise sources using sound pressure. Survey method using an enveloping measurement surface over a reflecting plane— 56 стр.
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 -- 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 -- 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 medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process— 24 стр.
Cleanrooms and associated controlled environments -- Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration— 28 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— 46 стр.
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials— 63 стр.
Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices— 12 стр.
Non-biological systems for use in sterilizers. Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S— 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 for terminally sterilized medical devices. Sealable pouches and reels of porous and plastic film construction. Requirements and test methods— 22 стр.
Packaging for terminally sterilized medical devices. Re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods— 22 стр.
