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:

Note: Configuration management is a means by which identification and traceability can be maintained. 7.5.3.2.2 Particular requirements for active implantable medical devices and implantable medical devices In defining the records required for traceability, the manufacturer shall include records of all components, materials and work environment conditions, if these could cause the medical dev ...

If the product is cleaned in accordance with clause (a) or clause (b) above, the requirements content in clauses (a) and (b) of sub-paragraph 6.4 do not apply prior to the cleaning process. 7.5.1.2.2 Installation activities If appropriate, the manufacturer shall establish documented requirements which contain acceptance criteria for installing and verifying the installation of the medical device o ...