This document provides requirements for the development, validation and routine control of moist heat sterilization processes for medical devices. The standard also contains guidance which is intended to explain the requirements set forth in the normative sections. The guidance given is intended to promote good practice related to moist heat sterilization processes according to this document. The application within industrial and health care settings is considered. 1.1 Inclusions 1.1.1 Moist heat sterilization processes covered by this document include but are not limited to: a) Saturated steam sterilization in which air is removed by venting; b) Saturated steam sterilization in which air is removed by active air removal; c) Contained product sterilization in which heat transfer is achieved by steam-air mixtures; d) Contained product sterilization in which heat transfer is achieved by water sprays. e) Contained product sterilization in which heat transfer is achieved by water immersion. NOTE 1 See Annex D where the processes are explained further. NOTE 2 Although the scope of this document is limited to medical devices, it specifies requirements and provides guidance that can be applicable to other health care products and industrial applications. 1.2 Exclusions 1.2.1 This document does not specify requirements for development, validation, and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. NOTE See ISO 22442-1, ISO 22442-2 and ISO 22442-3. 1.2.2 This document does not apply to those sterilization processes that are based on a combination of moist heat with other biocidal agents (e.g. formaldehyde) as the sterilizing agent. 1.2.3 This document does not detail a specified requirement for designating a medical device as sterile. NOTE Attention is drawn to national or regional requirements for designating medical devices as sterile. See, for example, EN 556-1 or ANSI/AAMI ST67. 1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of moist heat sterilization facilities. NOTE There could be applicable national or regional regulations for operational safety.