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: [email protected] or 1-212-642-4980 or Request Proposal Price.

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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 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

AAMI TIR12:2020

Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers

This technical information report (TIR) provides guidance to medical device manufacturers, who are required to provide instructions that detail the processing steps from pre-treatment at the point of use through the terminal process and storage to accompany reusable and single-use medical devices that are processed by a health care facility prior to clinical use. In addition, greater detail is provided about the processes and resources that a health care facility can have for processing devices. This should provide further assistance to medical device manufacturers (MDMs) in developing their processing instructions.

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.

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 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. 


Comprehensive guide to steam sterilization and sterility assurance in health care facilities (contains amendments)

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. The following amendments to ST79:2017 are included in this document: Amendment 1: Environmental services/fans/food and drink; Amendment 2: Inspection of insulated instruments; Amendment 3: Modification of content pertaining to frequency of cleaning for routine care of sterilizers for sterile processing areas in health care facilities; and Amendment 4: Content addressing recording B1 lot numbers in sterilizer records for sterile processing in health care facilities.

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.

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 TIR42:2021

Evaluation of particulate associated with vascular medical devices

This document provides information for defining appropriate test methods, determining the source of particulate, assessing the clinical risk of particulate, and establishing product particulate limits. Particulate could arise from many sources including materials, environment, and clinical use. This TIR is intended to offer guidance to the medical device industry when evaluating the tendency for medical devices to release particulate, identifying particulate sources, applying analytical methods for particulate testing, and developing particulate limits based on clinical risk.