《ISO 11139-2016 Eng 医疗保健品灭菌_术语》.pdf

Technical Information ANSI/AAMI/ISO TIR11139:2006 Report Sterilization of health care products— Vocabulary The Objectives and Uses of AAMI Standards and Recommended Practices It is most important that the objectives and potential uses of an AAMI Each AAMI standard or recommended practice reflects the product standard or recommended practice are clearly understood. collective expertise of a committee of health care professionals and The objectives of AAMIs technical development program derive industrial representatives, whose work has been reviewed nationally from AAMIs overall mission: the advancement of medical (and sometimes internationally). As such, the consensus instrumentation. Essential to such advancement are (1) a continued recommendations embodied in a standard or recommended practice increase in the safe and effective application of current technologies are intended to respond to clinical needs and, ultimately, to help to patient care, and (2) the encouragement of new technologies. It is ensure patient safety. A standard or recommended practice is limited, AAMIs view that standards and recommended practices can however, in the sense that it responds generally to perceived risks and contribute significantly to the advancement of medical conditions that may not always be relevant to specific situations. A instrumentation, provided that they are drafted with attention to these standard or recommend