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

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

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1   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 International Standard is limited to medical devices, it specifies requirements and provides guidance that might be applicable to other health care products.

1.1.2   Although this International Standard primarily addresses dry heat sterilization, it also specifies requirements and provides guidance in relation to depyrogenation processes using dry heat.

NOTE Dry heat is often used for the depyrogenation of equipment, components and health care products and its effectiveness has been demonstrated. The process parameters for sterilization and/or depyrogenation are time and temperature. Because the conditions for depyrogenation are typically more severe than those required for sterilization, a process that has been validated for productdepyrogenation will result in productsterility without additional validation.