Sterilization of medical devices. Validation and routine control of sterilization by moist heat Ingestion-build-251241 Appendix 1

Appendix 1

Performance requirements

designation of revisions

Specific joint types covered by this document include butt welded joints

Applicability

Sterilization of medical devices. Validation and routine control of sterilization by moist heat Ingestion-build-251241 Appendix 1This European Standard specifies requirements for the process development, validation, process control and monitoring of the sterilization of medical devices using moist heat. This method is based on the monitoring of the physical factors that cause the product to become sterile and presupposes that prior to validation the sterilizer and its installation conform to an appropriate specification. This European Standard does not describe a quality