Enhancing international commerce and public health

摘要

The Association for the Advancement of Medical Instrumentation (AAMI) is a US-based standards developing organization that supports and relies on the ISO and IEC standards systems to achieve important goals. AAMI also provides education, information, certification and communications programmes for its members from the manufacturing industry, governments, hospitals and other health care institutions. Its members are developers, managers and users of medical technology from all areas of health care, with a strong emphasis on biomedical engineering. AAMI's primary goal is to advance medical technology through standards and education, information and various recognition programmes. Benefits for members with a particular interest in standards include various standards-development activities, other fora, education, publications and other forms of communications in the following areas: (1) Electromedical; (2) Sterilization technology; (3) Quality systems and risk management; (4) Cardiovascular implants, active implantable medical devices, and biological evaluation of medical devices; (5) Technical information reports, technology conference reports, and position statements on a wide range of issues of concern to the health care community; (6) Technical advice from AAMI experts. The AAMI international standards programme was refocused and expanded with the emergence of the European Union's "New Approach" to the use of standards, resulting in a new emphasis on global standards. AAMI believes that the concept of the European approach has significantly contributed to the use of standards as an important resource for regulation and commerce. AAMI has worked very closely with leaders all over the world to provide secretariat, financial and leadership support in important areas of international standards. AAMI administers over 100 national and international technical committees and advisory groups. Another form of support is AAMI's policy of adopting ISO and IEC standards as new or revised American national standards. In a relatively short period of time, the world community, working through ISO and IEC, has developed a comprehensive body of international medical device standards that enhance public safety and commerce. All involved should be commended for this successful undertaking and result.