scope:

General

This TIR addresses how to determine the water quality needs for reprocessing various categories of medical devices at various stages of reprocessing and how to assess, generate, monitor, and maintain water meeting those requirements.

Inclusions

This TIR covers the quality of the water used to clean, rinse, disinfect, and sterilize medical devices. It defines water types on the basis of hardness, pH, microorganism levels, endotoxin levels, and other characteristics. The following specific topics are covered:

a) Importance of water quality and effective water treatment

b) Categories of water quality for medical device reprocessing

c) Selection of water quality

d) Water treatment systems

e) Monitoring of water quality

f) Strategies for microorganism control

g) Personnel considerations

h) Continuous quality improvement

i) Troubleshooting water quality issues

This TIR also provides definitions of terms and a bibliography. The annexes contain technical details pertaining to water treatment and monitoring for the benefit of water maintenance personnel.

Exclusions

This TIR does not cover the water requirements for hemodialysis applications. See ANSI/AAMI/ISO 13959, ANSI/AAMI/ISO 11663, and ANSI/AAMI RD47.

This TIR does not address water treatment performed within medical washers, washer-disinfectors, or automated endoscope reprocessors (AERs); it covers only the water coming into such equipment. The internal filtering or other additional treatment performed within a medical washer, washer-disinfector, or AER is the responsibility of the equipment manufacturer. However, it is in the best interest of reprocessing personnel to be informed of the internal water treatment apparatus and of the equipment manufacturer to take into account the water quality recommendations of this document. See the ANSI/AAMI and ISO 15883 series of documents.