Expertise Thermal Validation Validation of autoclaves

Validation of autoclaves

Autoclaves, along with washing machines, are the installations that keep the central sterilization department in a hospital running. For the validation of autoclaves, our validation experts adhere to the following standards: NEN-EN 285, NEN-EN-ISO 17665-1, NPR-CEN-ISO/TS 17665-2, and take into account the recommendations of the RIVM (National Institute for Public Health and the Environment) and the HGR (High Council of Health).

Autoclaves and washing machines are crucial devices for the central sterilization department in a hospital. After cleaning and disinfection, materials are sterilized with steam in autoclaves, after which they are ready for use in the operating room again.


Autoclave Validation Process

Identification of the autoclave and associated materials (cart and packaging) takes place first. In the following steps of the validation, the measured parameters (such as temperature and pressure) of the autoclave are compared with the preset values.

Vacuum Leak Test

With the help of a portable pressure sensor, it is determined whether the autoclave is capable of creating and maintaining a vacuum.

Bowie & Dick test

Successful sterilization can only occur after the removal of air from the chamber. Then, the generated steam can spread throughout the entire chamber. To check this requirement, a double control is used:

  • The use of the hospital’s test system (ETS or paper test package)
  • Monitoring of temperature and pressure with the help of mobile sensors

Validation of Sterilization Programs


Measurement of temperature and pressure with the help of mobile temperature sensors. All acceptance criteria from the standard are tested during this validation process.

Thorough visual inspection and/or weighing of the packages


Agidens has over 25 years of experience in validation & compliance and is a well-known name in the hospital world. Our clients trust us because of our expertise and ‘no nonsense’ approach, and with reliable service, we are a long-term partner.

Ellen Van Der Plas - Agidens