scope:

General

This standard establishes minimum requirements for the water quality used at different stages in the processing of medical devices (e.g., reusable devices and single-use devices provided non-sterile requiring processing prior to use such as non-sterile implants and processed single-use devices) to make them ready for use on the next patient. These requirements are established to assist medical device processing professionals in the selection of the appropriate water quality needed for cleaning, rinsing, disinfection, and sterilization of medical devices.

Inclusions

This standard covers the quality of the water delivered to the point-of-use and used in medical device processing (cleaning, rinsing, disinfection and sterilization). It defines water types based on the qualities possessed and where it will be used. Included in this document are:

a) Responsibility for the water management program;

b) Importance of water quality;

c) Adverse effects of water impurities on medical device processing;

d) Categories and requirements of water quality for medical device processing;

e) Selection of water of the appropriate quality;

f) Purity requirements of water used to generate steam;

g) Effective water treatment and qualification;

h) Considerations for ongoing maintenance, monitoring and quality improvement of the water treatment system;

i) Troubleshooting water quality issues.

This standard also provides definitions of terms and a bibliography.

Exclusions

This standard does not cover:

a) Water requirements for hemodialysis applications;

b) Water requirements for laboratory use;

c) Steam quality requirements (i.e., physical qualities of steam such as: moisture content, noncondensable gas content and Superheat). See ANSI/AAMI ST79 [8];

d) Water treatment performed within the medical device processing equipment (e.g., washers, washer/disinfectors, or automated endoscope reprocessors (AERs);

e) Water quality of municipal water supply; and

f) Testing of water post use.