AAMI PROC pdf free download

AAMI PROC pdf free download.National and International (U.S. TAG) Policies and Procedures Manuals.
1. Program scope and organization This section of the manual covers the scope, objectives, and basic organization of the AAMI standards and technical publications program. 1.1 Program scope The Association for the Advancement of Medical Instrumentation (AAMI) is recognized as one of the foremost voluntary standards-setting organizations in the United States. The AAMI standards program is accredited by the American National Standards Institute (ANSI) — the organization that coordinates the development and promotion of all U.S. voluntary standards and that officially represents the United States in international standards-setting — under the following scope. Standards for medical devices and for healthcare products and services. At the heart of the program are AAMI’s technical committees, made up of persons who are knowledgeable about the subject matter within the scope of the committee’s work through technical, medical, industrial, or other experience in the field and falling into one of three interest categories —medical device producers, users, or general interests. Collectively, these experts form a true interdisciplinary group that develops standards and other technical documents toward the aim of improving safety of medical instrumentation and advancing medical technology. Perhaps best known for the development of American National Standards for electromedical devices and recommended practices in the area of sterilization technology, AAMI standards committees also develop technical information reports, technology conference reports, and position statements on a wide range of issues of concern to the health care community, including quality systems and corresponding general aspects of medical devices, cardiovascular implants, active implantable medical devices, and biological evaluation of medical devices.Another major aspect of the program is the administration of international technical committees, which write international standards, and of U.S. technical advisory groups (TAGs), which develop the comments on behalf of the United States and vote on international documents. These aspects of the AAMI standards program are governed in many respects by the policies and procedures of the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC), and the American National Standards Institute (the official U.S. member to these bodies). In addition, AAMI has developed a separate policies and procedures manual which (a) explains in greater detail the AAMI International Standards Program, and (b) sets forth policies and procedures unique to AAMI in its administration of U.S. technical advisory groups. In short, with over 1 00 national and international technical committees and advisory groups under its administration, AAMI plays a significant role in the development of medical device standards with worldwide application. NOTE ⎯ Hereafter, information provided in this manual refers only to the AAMI National Standards Program, unless otherwise specified. 1.2 Program objective The purpose of the AAMI standards program is to assist the health care professions and industry in the U.S. and abroad with the use, acceptance, and advancement of medical technology. This is accomplished by AAMI technical committees, which develop consensus recommendations on medical device safety, performance, and use. As adjuncts to these recommendations, AAMI also establishes referee test methods, conducts technical conferences and educational programs, and issues expert opinion statements on technical issues of concern to the AAMI membership and the health care community. The end result of these activities is publication of voluntary standards, recommended practices, technical information reports, and conference reports, all of which contribute toward advancing medical technology and the quality of patient care. 1.3 Program benefits AAMI standards, recommended practices, and other technical documents reflect the combined knowledge of medical device producers, users, general interests and specific technology experts, and are voluntarily conceived and used. Their application is solely at the discretion and judgment of the user of the document. Consequently, the AAMI standards program benefits the industry and the health care professions in a number of ways, without restricting technological advancement.AAMI PROC  pdf download.