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  • ISO
    ISO/TS 5111:2022 Guidance on quality of water for sterilizers, sterilization and washer-disinfectors for health care products
    Edition: 2022
    $460.92
    / user per year

Content Description

This document provides guidance on the quality of water for sterilizers, sterilization and washer-disinfectors (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).

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).



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About ISO

ISO, the International Organization for Standardization, brings global experts together to agree on the best way of doing things – for anything from making a product to managing a process. As one of the oldest non-governmental international organizations, ISO has enabled trade and cooperation between people and companies all over the world since 1946. The International Standards published by ISO serve to make lives easier, safer and better.
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