There is a portfolio of European Standards for development, validation and routine control of sterilization processes. These standards are European adoptions of International Standards. 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.
The standards are intended to ensure that the sterilization process is reliable and reproducible. 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. These standards provide a means to demonstrate conformity with the requirements for sterility for terminally-sterilized medical devices specified in EN 556-1.
All the standards for validation and routine control have a common format and use a common set of definitions. The common structure includes:
Sterilizing agent characterization – defines the sterilizing agent
Process and equipment characterization – defines the entire sterilization process and the equipment necessary to deliver the sterilization process safely and reproducibly
Product definition – defines the product to be sterilized, including the microbiological quality of the product prior to sterilization and the manner in which product is packaged and presented for sterilization
Process definition – details a specification for the sterilization process to be applied to the defined product
Validation – demonstrates that the sterilization process established in the process definition can be delivered effectively and reproducibly to the sterilization load. Validation consists of installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ)
IQ is undertaken to demonstrate that the sterilization equipment and any ancillary items have been supplied and installed in accordance with their specification
OQ is carried out either with unloaded equipment or using appropriate test materials to demonstrate the capability of the equipment to deliver the sterilization process that has been defined
PQ is the stage of validation that uses product to demonstrate that the equipment consistently operates in accordance with predetermined criteria and the process yields product that is sterile and meets the specified requirements
Routine monitoring and control – demonstrates that the validated and specified sterilization process has been delivered to the product
Product release from sterilization – specifies the procedure for product release from sterilization
Maintaining process effectiveness – addresses ensuring the consistent condition of product presented for sterilization, maintenance and calibration of equipment, assessment of changes to product, process or sterilizing equipment and periodic requalification