Records of validation shall be maintained. 7.5.2.2 Particular requirements for sterile medical devices The manufacturer shall establish documented procedures for the validation of sterilization processes. Sterilization processes shall be validated prior to initial use. The records of validation of each sterilization process shall be maintained. 7.5.3 Identification and traceability:

The manufacturer shall establish arrangements for these processes including, as applicable:— (a) defined criteria for review and approval of the processes; (b) approval of equipment and qualification of personnel; (c) use of specific methods and procedures; (d) requirements for records; and (e) revalidation. The manufacturer shall establish documented procedures for the validation of the applicati ...