The manufacturer shall establish and maintain a record for each batch of medical device or in vitro diagnostic medical devices that provides traceability and identifies the amount manufactured and amount approved for distribution. The batch record shall be verified and approved. 7.5.1.2 Control of production and service provision—Specific requirements 7.5.1.2.1 Cleanliness of product and contamination control The manufacturer shall establish documented requirements for cleanliness of product if— (a) product is cleaned by the manufacturer prior to sterilisation or its use; or (b) product is supplied non-sterile to be subjected to a cleaning process prior to sterilisation or its use; or (c) product is supplied to be used non-sterile and its cleanliness is of significance in use; or (d) process agents are to be removed from product during manufacture.