Sterilization of health care products. Radiation. Requirements for the development, validation and routine control of a sterilization process for medical devices.

Standard published on 13.7.2026

Tracked Changes. Sterilization of health care products. Radiation. Requirements for the development, validation and routine control of a sterilization process for medical devices.

Standard published on 1.7.2026

Sterilization of health care products. Radiation. Establishing the sterilization dose.

Standard published on 21.4.2023

Sterilization of health care products. Radiation. Guidance on dosimetric aspects of development, validation and routine control.

Standard published on 23.8.2017

Tracked Changes. Sterilization of health care products. Radiation. Guidance on dosimetric aspects of development, validation and routine control.

Standard published on 24.2.2020

Sterilization of health care products. Biological indicators. General requirements.

Standard published on 30.4.2017

Tracked Changes. Sterilization of health care products. Biological indicators. General requirements.

Standard published on 25.2.2020

Sterilization of health care products. Biological indicators. Biological indicators for ethylene oxide sterilization processes.

Standard published on 30.4.2017

Sterilization of health care products. Biological indicators. Biological indicators for moist heat sterilization processes.

Standard published on 30.4.2017

Sterilization of health care products. Biological indicators. Biological indicators for dry heat sterilization processes.

Standard published on 30.4.2017