Sterilization of health care products. Chemical indicators. Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test— 32 стр.
Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards— 50 стр.
Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards— 60 стр.
Sterilization of health care products. Chemical indicators. Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration— 46 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.