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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 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.


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.


ANSI/AAMI/IEC 62304:2006

Medical device software - Software life cycle processes

This standard defines the life cycle requirements for MEDICAL DEVICE SOFTWARE. The set of PROCESSES, ACTIVITIES, and TASKS described in this standard establishes a common framework for MEDICAL DEVICE SOFTWARE life cycle PROCESSES.



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.


AAMI TIR12:2010 (AAMI TIR 12:2010)

Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers

Includes the following topics : Design considerations: Assurance that a device can be safely and effectively reprocessed begins with the design of the device. Section 3 of the TIR describes categories of medical devices and the materials and other design characteristics that affect the ability of health care personnel to clean, disinfect, and/or sterilize devices adequately; Decontamination: A device cannot be disinfected adequately or sterilized to an adequate sterility assurance level (SAL) if it cannot be cleaned thoroughly. Section 4 addresses variables associated with cleaning and other decontamination processes used in health care facilities, as well as the minimum information that the device manufacturer should supply to health care personnel; Disinfection: Section 5 describes the levels of disinfection, the criteria for selecting chemical disinfectants, and the testing that device manufacturers should perform to establish the effectiveness of the disinfection processes recommended for their products; Sterilization: Section 6 describes the sterilization processes commonly used in health care facilities, the minimum information that device manufacturers should provide with their products, and the procedures that device manufacturers should use to qualify the sterilization parameters that they recommend


AAMI TIR30:2011 (R2016)

A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices

This report is intended as a resource for manufacturers of medical devices who must validate the instructions for reprocessing that they include with their devices. In addition to describing available processes, materials, test methods, and acceptance criteria for cleaning medical devices that are labeled by the manufacturer for reuse and reprocessing, the report also discusses some of the underlying problems and challenges associated with validating a cleaning method. Extensive references and a sample cleaning validation outline and also are included. 


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 TIR16:2017

Microbiological aspects of ethylene oxide sterilization

This technical information report (TIR) addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process. It does not cover the various factors that can have an effect on the bioburden of the product and on the sterilization process. This TIR provides additional guidance to ANSI/AAMI/ISO 11135:2014 for medical device manufacturers, including those that use contract sterilization facilities or contract sterilization operations.


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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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