Standards Development

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.

Purpose

This document is intended to bridge the gap between the manufacturer of reusable medical devices and the facility responsible for device processing. ISO/TC 198 WG 12 has provided a series of documents giving requirements for the medical device manufacturer’s instructions for use. These requirements must be validated to demonstrate effective processes. Reusable medical device reprocessors do not typically process reusable medical devices alone in a single process and will clean many devices together with similar (but not identical) instructions for use. ISO 17664-1 specifies requirements for the information to be provided by the medical device manufacturer for reprocessing.

Only ISO/TS 17665-3 gives specificity for designation to a product family or master product, but for steam sterilization and not cleaning. The terms product family and master product are used within a number of documents (i.e., ISO 17664 series, AAMI TIR12 and AAMI ST98) but these documents do not provide specific guidance to the medical device manufacturer to define product families by identification of quantitative attributes necessary for cleaning.

The connection between the device manufacturer and the processing facility is intended to be communicated through the IFU. In addition to providing guidance to the manufacturer, this document will provide guidance to the clinical processor to establish processing workflow based on device cleaning classification and to allow verification of the cleaning instructions being performed effectively for all reusable medical devices.