DANSK DS/ISO 20857 PDF

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. 1.1.2 Dry heat sterilization processes covered by this International Standard include but are not limited to: a) forced air cycles b) convection cycles 1.1.3 Although this standard primarily addresses dry heat sterilization, it also covers depyrogenation processes.