Standards Development

Scope

1.1 Inclusions

This document provides guidance on the quality of water for both sterilizers for terminal sterilization and washer-disinfectors used to process health care products.

This document covers the quality of water used directly for cleaning, thermal and chemical disinfection and sterilization, as feedwater for the generation of steam, as a service to a sterilizer or washerdisinfector, or as a cooling agent.

This document provides specific guidance on:

- water quality for different applications;

- water treatment methods;

- water distribution and storage; and

- monitoring and control of water quality.

NOTE Guidance given in this document can also be applied to specifications for the quality of water required for manual cleaning or disinfection of medical devices (see ISO 17664 series).

1.2 Exclusions

This document does not supersede or modify requirements or test methods of published standards applying to;

- development, validation or routine control and monitoring of sterilization processs,

- sterilizers, or

- washer-disinfectors.

Purpose

There are references to water quality in a number of existing ISO TC 198 documents and some national or regional standards. In many of these applications, water, or steam generated from it, comes into contact with the healthcare product and can affect the safety, quality or performance of that product.

The current standards that mention water quality do so in a variety of different ways and to different extents.

The purpose of this document is to bring together the disparate approaches used in existing standards to generate a single document that can be referenced when needed by individual standards for validation and routine control of sterilization, sterilizers and washer-disinfectors.

Consistent standards for water quality will benefit manufacturers of equipment that use water, service providers designing installations of sterilizers or washer-disinfectors, and users of sterilizers and washer-disinfectors.