1. Scope
1.1 This Standard defines essential elements for using ethylene oxide to sterilize products in hospitals and similar health care facilities with the object of achieving an adequate level of sterility assurance and minimizing the risk of injury to patients and to the health and safety of hospital staff. Note: ""Similar health care facilities"" are considered to include nursing homes, extended-care facilities, clinics, medical and dental offices, and health units in industry. For convenience, the shorter term ""hospital"" is used herein.
1.2 Inclusions This Standard includes requirements for (a) preparation and packaging of products requiring sterilization; (b) machine loading and operation; (c) aeration and storage of sterilized products; (d) sterility assurance; (e) purchase agreements regarding sterilizable products and packaging materials; and (f) maintenance and sterilizer quality assurance.
1.3 Exclusions This Standard does not include specific requirements for construction and performance of ethylene oxide sterilizers.
1.4 The v