ISO/AWI TS 17664-3

Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 3: Guidance on the designation of a reusable medical device to a cleaning classification.

Scope

This document gives guidance on how to allocate reusable medical devices to a cleaning classification system that allows designation to a product family. Medical device design, material of construction and intended use are used as attributes for device classification and are used to designate processing parameters for cleaning. Guidance is provided for the designation of a master product within a product family. The cleaning classification system is comprised of two parts: i) classification of reusable medical devices; ii) classification of manual and or automated cleaning processes suitable for the cleaning classification assigned to a reusable medical device. This allows grouping of reusable medical devices into product families during routine cleaning and identification of master products during cleaning validation. It is applicable to manufacturers devising cleaning methods and instructions for processing, to healthcare facilities and to wherever medical devices are cleaned to be made ready for use or reuse.