This document gives guidance on designating medical devices to cleaning classification categories, attributes to be used for medical device classification, and designation of a cleaning process. The cleaning classification category is comprised of two parts: a) designate medical devices to a product family; b) designate product families to cleaning processes. NOTE 1 This allows grouping of medical devices into cleaning classification categories during cleaning and identification of master products during cleaning validation. This document is applicable to manufacturers devising cleaning methods and instructions for processing. It also applies to any processing facility where medical devices are cleaned. This document does not cover processing of single-use devices provided as sterile before use and textile devices. NOTE 2 Manual cleaning steps before automated cleaning do not include steps that are considered pre-cleaning, such as bedside pre-cleaning that can be required whether subsequently using automated or manual cleaning.