What is this standard about?
Dose measurement is an integral part of radiation sterilization. This standard provides guidance on the application of dose measurements (dosimetry) during all stages of the sterilization process.
Who is this standard for?
- Sterilization equipment manufacturers
- Sterilization service providers
- Infection control professionals
- Other professionals responsible for sterilization
Why should you use this standard?
It gives guidance on dosimetry procedures relating to the development, validation and routine control of radiation sterilization processes as described in:
- BS EN ISO 11137-1:2015 Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices and
- BS EN ISO 11137-2:2015 Sterilization of health care products. Radiation. Establishing the sterilization dose.
It also provides explanations and methods regarded as suitable for complying with requirements.
What’s changed since the last update?
The revised standard:
- Includes much more guidance on dose measurement uncertainty to help with meeting the dosimetric requirements in BS EN ISO 11137-1 and BS EN ISO 11137-2
- Introduces and formally defines the ideas of ‘direct’ and ‘indirect’ measurement
Provides guidance on target doses based on measurement uncertainty considerations and process variability