Sterilisering av medicintekniska produkter - Fuktig värme - Del 1: Krav på utveckling, validering och rutinkontroll av steriliseringsprocesser för medicintekniska produkter (ISO 17665-1:2006, IDT)
pe 1.1 Inclusions 1.1.1 This part of ISO 17665 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices. NOTE Although the scope of this part of ISO 17665 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other health care products. 1.1.2 Moist heat sterilization processes covered by this part of ISO 17665 include but are not limited to: a) saturated steam venting systems; b) saturated steam active air removal systems; c) air steam mixtures; d) water spray; e) water immersion. NOTE See also Annex E. 1.2 Exclusions 1.2.1 This part of ISO 17665 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. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. NOTE See also ISO 22442-1, ISO 22442-2 and ISO 22442-3. 1.2.2 This part of ISO 17665 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 part of ISO 17665 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.