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AAMI: Assoc. for the Advancement of Medical Instrumentation

AAMI, the Association for the Advancement of Medical Instrumentation, is a nonprofit organization that develops and publishes standards detailing the proper production quality for medical instruments and the procedures in which they are used. Headquartered near Washington, D.C., United States, AAMI membership extends to over 6,000 individuals and 375 organizations. Backed by national consensus, AAMI standards are one of the benchmarks used in critical health facility inspections. AAMI also serves as the secretariat to ISO/TCs 198 and 210 (International Organization for Standardization/Technical Committee), as well as the administrator for the U.S. TAGs (United States Technical Advisory Group) to many ISO/TCs and their subcommittees. Standards from AAMI are available both individually, directly through the ANSI webstore, and as part of a Standards Subscription. If you or your organization are interested in easy, managed, online access to standards that can be shared, a Standards Subscription may be what you need - please contact us at: StandardsSubscriptions@ansi.org or 1-212-642-4980 or Request Proposal Price.

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ANSI/AAMI ST72:2019

Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing

Specifies general criteria to be applied in the determination of bacterial endotoxins on or in medical devices, components, or raw materials employing bacterial endotoxins test (BET) methods using amebocyte lysate reagents from Limulus polyphemus or Tachypleus tridentatus. The document is not applicable to the evaluation of pyrogens other than bacterial endotoxins.


ANSI/AAMI PB70:2012 (ANSI/AAMI PB 70:2012)

Liquid barrier performance and classification of protective apparel and drapes in health care facilities

This standard establishes minimum barrier performance requirements, a classification system, and associated labeling requirements for protective apparel, surgical drapes, and drape accessories intended for use in health care facilities.


AAMI TIR45:2012 (R2018)

Guidance on the use of AGILE practices in the development of medical device software

Over the past several years, AGILE software development has become an accepted method for developing software products. There have been questions from both manufacturers and regulators as to whether (or which) AGILE practices are appropriate for developing medical device software. Enough medical device manufacturers have implemented AGILE practices in their software development so that answers to these questions can be documented. Having clear guidance of which practices have been found to be appropriate will be very useful for all developers of medical device software. This TIR will provide recommendations for complying with international standards and U.S. Food and Drug Administration (FDA) guidance documents when using AGILE practices to develop medical device software


ANSI/AAMI/ISO 14971:2019

Medical devices - Application of risk management to medical devices

Specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.


ANSI/AAMI ST79:2017

Comprehensive guide to steam sterilization and sterility assurance in health care facilities

This recommended practice covers steam sterilization in health care facilities. The recommendations are intended to promote sterility assurance and to guide health care personnel in the proper use of processing equipment. Included within the scope of the recommended practice are functional and physical design criteria for sterilization processing areas (decontamination, preparation, sterilization, and sterile storage areas); staff qualifications, education, and other personnel considerations; processing procedures; installation, care, and maintenance of steam sterilizers; quality control; and quality process improvement.


ANSI/AAMI ST72:2019

Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing

Specifies general criteria to be applied in the determination of bacterial endotoxins on or in medical devices, components, or raw materials employing bacterial endotoxins test (BET) methods using amebocyte lysate reagents from Limulus polyphemus or Tachypleus tridentatus. The document is not applicable to the evaluation of pyrogens other than bacterial endotoxins.


ANSI/AAMI HE75:2009 (R2018)

Human factors engineering - Design of medical devices

This recommended practice covers general human factors engineering (HFE) principles, specific HFE principles geared towards certain user-interface attributes, and special applications of HFE (e.g., connectors, controls, visual displays, automation, software–user interfaces, hand tools, workstations, mobile medical devices, home health care devices


AAMI TIR28: 2016

Product adoption and process equivalence for ethylene oxide sterilization

This technical information report provides guidance for the adoption of new or modified products into an existing validated sterilization process and for the determination of equivalence of a sterilization process as conducted with different equipment. Guidance is intended to augment the ANSI/AAMI/ISO 11135 series in the areas of product adoption and process equivalence.


AAMI TIR57: 2016

Principles for medical device security - Risk management

Provides guidance on methods to perform information security risk management for a medical device in the context of the Safety Risk Management process required by ISO 14971. The TIR incorporates the expanded view of risk management from IEC 80001-1 by incorporating the same key properties of Safety, Effectiveness and Data & Systems Security with Annexes that provide process details and illustrative examples.


AAMI TIR17: 2017

Compatibility of materials subject to sterilization

his technical information report provides guidance for health care product manufacturers in thequalification of polymeric materials, ceramics, and metals for use in health care products that are sterilized by the following modalities: a) radiation (gamma, electron beam, or x-ray); b) ethylene oxide; c) moist heat (steam); d) dry heat; e) hydrogen peroxide; f) nitrogen dioxide, g) peracetic acid vapor, h) liquid peracetic acid, and i) hydrogen peroxide–ozone. Annexes address the specific sterilization modality concerns.


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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

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