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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.

Below are AAMI's best-selling standards. To find additional standards, please use the search bar above.

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ANSI/AAMI ST72:2011(R2016)

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

This recommended practice specifies general criteria to be applied in the determination of bacterial endotoxins (pyrogens) on sterilized or sterilizable healthcare products, components or raw materials. Endotoxin methodologies covered include both qualitative (limit) methods and quantitative (end-point) methods. The recommended practice excludes determination of pyrogens other than bacterial endotoxins.


ANSI/AAMI HE75:2009 (R2013) (ANSI/AAMI HE 75:2009 (R2013))

Human factors engineering - Design of medical devices

This recommended practice addresses a broad range of human factors engineering (HFE) topics in a structured format. Examples are provided, as are references to more detailed information. The material emphasizes adoption of a user-centered focus throughout the product design and development process, with the goal of making medical devices easier to use and less prone to use error.



AAMI TIR45:2012 (AAMI TIR 45:2012)

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

This Technical Information Report (TIR) provides perspectives on the application of AGILE during medical device software development.


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 62366-1:2015

Medical devices - Part 1: Application of usability engineering to medical devices

Specifies a PROCESS for a MANUFACTURER to analyze, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY ENGINEERING (HUMAN FACTORSENGINEERING) PROCESS permits the MANUFACTURER to assess and mitigate RISKS associated with CORRECTUSE and USE ERRORS, i.e., NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE. Partial revision of ANSI/AAMI/IEC 62366:2007 (R2013).


ANSI/AAMI HE75 and ANSI/AAMI/IEC 62366 Human Factor Set

ANSI/AAMI HE75 and ANSI/AAMI/IEC 62366 Human Factor Set

The ANSI/AAMI HE75 and ANSI/AAMI/IEC 62366 Human Factor Set addresses a broad range of human factors engineering (HFE) topics in a structured format. The material emphasizes adoption of a user-centered focus throughout the product design and development process, with the goal of making medical devices easier to use and less prone to use error. By providing a structured approach to user interface design, this set documents can help manufacturers develop safe and usable medical devices.

 
     
  • The ANSI/AAMI HE75 and ANSI/AAMI/IEC 62366 Human Factor Set includes
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  • ANSI/AAMI HE75:2009 (R2013) (ANSI/AAMI HE 75:2009 (R2013))
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  • ANSI/AAMI/IEC 62366-1:2015
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ANSI/AAMI EC12:2000 (R2015)

Disposable ECG electrodes

Establishes minimum labeling, safety, and performance requirements for disposable electrodes used for diagnostic electrocardiography (ECG) or ECG monitoring..


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/IEC 62304:2006/A1:2016

Medical device software - Software life cycle processes - Amendment

This standard applies to the development and maintenance of Medical Device Software when software is itself a medical device or when software is an embedded or integral part of the final Medical Device. This standard describes processes that are intended to be applied to software which executes on a processor or which is executed by other software (for example an interpreter) which executes on a processor.


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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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