SIST EN 550:2000

Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization

1.1 This European Standard specifies the requirements for the development, validation, process control and monitoring of the sterilization of medical devices using ethylene oxide.   Note: Specifications for sterilizers are being prepared by CEN/TC 102.  1.2 This European Standard does not describe a quality assurance system for the control of all stages of manufacture.   Note: Attention is drawn to the standards for quality systems (see EN 46001 or EN 46002) which control all stages of manufacture including the sterilization process. It is not a requirement of this standard to have a complete quality system during manufacture but certain elements of such a system are required and these are normatively referenced at appropriate places in the text.   1.3 This European Standard does not cover operator safety (see note).   Note: Ethylene oxide is toxic, flammable and explosive. Attention is drawn to the existence in some countries of national regualtions laying down safety requirements for handling ethylene oxide and for premises in which it is used.  1.4 This European Standard does not cover the level of residual ethylene oxide within medical devices.   Note: Attention is drawn to the existence in some countries of standards stipulating the level of ethylene oxide residue within medical devices.