scope:

Inclusions

This document provides guidance on the quality of water for sterilizers, sterilization and washerdisinfectors (WDs) used to process health care products.

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

This document provides specific guidance on:

- water quality for different applications;

- water treatment systems;

- water distribution and storage;

- monitoring and control of water quality;

- investigating out of specification results.

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 the ISO 17664 series).

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 a sterilization process;

- sterilizers;

- WDs.

This document does not specify requirements for water treatment systems (see, for example, standards for particular sterilizers or WDs).

This document does not specify the water quality for manufacturing pharmaceuticals, cell-based health care products or medical devices.

This document does not provide guidance on the attributes of steam quality (see, for example, EN 285).