Process and equipment characterization – defines the entire sterilization process and the equipment necessary to deliver the sterilization process safely and reproducibly.Sterilizing agent characterization – defines the sterilizing agent.These standards provide a means to demonstrate conformity with the requirements for sterility for terminally-sterilized medical devices specified in EN 556-1.Īll the standards for validation and routine control have a common format and use a common set of definitions. Reliability and reproducibility provide confidence that predictions can be made that there is an acceptable, low probability of there being a viable microorganism present on device after sterilization. The standards are intended to ensure that the sterilization process is reliable and reproducible. These standards for validation and routine control of sterilization are listed in the draft Standardization Request of priority standards to be harmonized for the MDR. These standards are European adoptions of International Standards. There is a portfolio of European Standards for development, validation and routine control of sterilization processes. ![]() Standards for validation and routine control have a common format and use a common set of definitions
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