ISO/AWI 25442

Sterilization of health care products — Test procedure for measurement of temperature, pressure, and humidity in equipment

Scope

This document establishes procedures for measuring temperature, humidity and pressure tests on equipment critical to the sterilization process.
The document includes specifications for data collecting instruments, requirements for data protection, requirements for personnel involved in the qualification, maintenance and calibration of data collecting systems, standard instruments for calibration, sensors for measurement of temperature, pressure and other variables, periodicity of test equipment qualification, and guidance on the number and position of the sensors for each piece of equipment.