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 or in vitro diagnostic medical devices. If the agreed customer requirements allow installation to be performed other than by manufacturer or its authorised agent, the manufacturer shall provide documented requirements for installation and verification. Records of installation an verification performed by the manufacturer or its authorized agent shall be maintained. 7.5.1.3 Particular requirements for sterile medical devices.