Association for the Advancement of Medical

Sterilisation of Health Care Products—Chemical Indicators, Part 1 General Requirements, AAMI 1114001-D, 1995-11-30, Association for the Advancement of Medical Instmmentation, Arlington, Va., 1995, proposed new American National Standard. 

Association-dissociation equilibrium, in micellization, 24 128, 129-131 Association for the Advancement of Medical Instrumentation (AAMI) Standards, 26 818-819 Association of American Feed Control Officials (AAFCO), 10 856 Nutrient Profiles, 10 857, 858-859t... 

AALAS American Association of Laboratory Animal Science AAMI Association for the Advancement of Medical Instrumentation... 

In Japan, prior to 1979 no formal regulatory guidance was available to western pharmaceutical companies and a marketing authorization of new drug products could not be obtained by non-Japanese manufacturers. The PMDA as we know it today was established in 2004 from the earlier Pharmaceutical and Medical Devices Evaluation Centre (PMDEC), the Organisation for Pharmaceutical Safety and Research (OPSR), and the Japanese Association for the Advancement of Medical Equipment (JAAME). 

Specifically for medical devices, the Medical Device Software Committee of the Association for the Advancement of Medical Instrumentation (AAMI) has taken on the task of developing a standard4 for use in the medical device business sector based upon the framework established in ISO12207. 

The Association for the Advancement of Medical Instrumentation has issued a standard recommending that water used in the preparation of dialysate solution contain less than 10 g aluminum per liter. The purpose is to limit the unintentional administration of aluminum to dialysis patients whose renal dysfunction and the inefficiency of dialysis equipment to remove aluminum could cause an aluminum buildup to biologically hazardous levels (AAMI 1998). 

AAMI (Association for the Advancement of Medical Instrumentation). 1998. Water Quality for Dialysis, 3rd edition and Current Concepts in Hemodialyzer Reprocessing, 2nd edition. AAMI Dialysis Monograph Series. 

The use of radiation within a parenteral facility would have been considered unthinkable prior to the start of the twenty-first century. While y irradiation is typically a contracted service provided off-site, electron beam sterilization advances can make the installation of an in-house (and generally an in-line) system a real possibility. An in-line system would be utilized similarly to the gas/vapor systems described above for treatment of external surfaces for entry into either a clean room or isolator-based aseptic processing facility. The use of this same technology for terminal sterilization is also possible [1], Association for the Advancement of Medical Instrumentation (AAMI)/ISO 11137 provides widely accepted guidance on the development and validation of radiation sterilization processes. 

The research was supported in part by the Health and Labour Sciences Research Grants for Research on Advanced Medical Technology from The Ministry of Health, Labour and Welfare of Japan. We thank the Japan Association for the Advancement of Medical Equipment for supporting the Postdoctoral Fellowship for Dr. Jose Mario Barichello. 

Association for the Advancement of Medical Instrumentation (AAMI). 1110 North Glebe Road, Suite 220, Arlington, VA 22201-4795, U.S.A. Phone +1 703-525-4890, Fax +1 703-276-0793. E-mail customerservice aami.org. URL http // www.aami.org. Founded in 1967, AAMI is an alliance of over 6000 members, whose goal is increasing the understanding and use of medical instrumentation. It is a primary industry resource for national and international standards. AAMI standards may be purchased online some are available on CD. 

Methods of extraction and analysis have been published by the Association for the Advancement of Medical Instrumentation [12]. Water or other aqueous systems are most commonly used for extraction. Two extraction methods are lecammaxled, exhaustive extraction and simulated use. In fact both methods, if used correctly, represent simulated use. Exhaustive extraction is recommended for devices such as implants, which by merit of their prolonged contact with tissue over time can be expected to transfer all of their residual ethylene oxide to the recipient. Simulated use extraction of a less exhaustive nature might include fluid path extraction over a simulated maximum hold period for infusion sets and hypodermic syringes. Analysis is by gas chromatography. 

Yoganathan, A. P. Harrison, E. C. Corcoran, W. H., Ed. Procceedings of a Symposium of the 14th Annual Meeting of the Association for the Advancement of Medical Instrumentation, Prosthetic Heart Valves, 1980. 

Ideally, materials for medical and paramedical applications should be tested or evaluated at three level (1) on the ingredients used to make the basic resin, (2) on the final plastic or elastomeric material, and (3) on the final device. Organizations such as the Association for the Advancement of Medical Instrumentation, the U.S.A. Standard Institute, and the American Society for Testing and Materials (F4 Committee) have developed toxicity testing programs for materials used in medical apphcations. The American Dental Association has recommended standard procedures for biological evaluation of dental materials [74]. 

The Journal Biomedical Instrumentation and Technology is published by the Association for the Advancement of Medical Instrumentation. This bimonthly Journal has reports on biomedical instrumentation for clinical applications, and these include papers on biomedical sensors. 

American National Standard, Medical Electrical Equipment, Part 1 General requirements for basic safety and essential performance, ANSl/AAMl ES60601-1, 2005, Association for the Advancement of Medical Instrumentation, Arlington, VA. 

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