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 quantitative cleaning classification ISO/AWI TS 17664-3

Scope

This document gives guidance how to define the cleaning requirements of a reusable medical device by use of a quantitative cleaning classification system that allows designation to a product family. Medical device design features, material of construction and intended patient 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 quantitative 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 processing and identification of master products during cleaning validation.