scope:

1.1 Inclusions 1.1.1 This International Standard specifies requirements for the development, validation, and routine control of a dry heat sterilization process for medical devices. NOTE Although the scope of this standard is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other health care products. 1.1.3 Although this standard primarily addresses dry heat sterilization, it also specifies requirements and provides quidance in relation to depyrogenation processes using dry heat. NOTE Dry heat processes are often used for depyrogenation of equipment, components, and medical products, and their effectiveness has been demonstrated. The key process parameters for depyrogenation are time and temperature. Because the conditions for depyrogenation are typically more severe than those required for sterilization, products that have been validated for depyrogenation are generally considered sterile without additional validation.