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Standards, Codes & Specs

Association for the Advancement of Medical Instrumentation (AAMI)

AAMI standards for the manufacture, use and maintenance of medical devices.

Access the most up-to-date AAMI Standards with IHS

  • IHS is an authorized reseller of standards published by the Association for the Advancement of Medical Instrumentation (AAMI). IHS provides access to over 200 AAMI technical documents through subscription or individual purchase.

    Who Uses AAMI Standards:

    • Biomedical engineers and technicians 
    • Physicians, nurses, and hospital administrators educators and researchers 
    • Manufacturers 
    • Distributors 
    • Government representatives

    What the AAMI Standards can do:

    The AAMI standards include recommended practices, and guidance documents for healthcare facilities and the medical device industry.

    Examples of some topics covered in the AAMI standards are

    • Biological evaluation 
    • Handling and biological decontamination 
    • Quality management 
    • Packaging 
    • Process control 
    • Specific devices such as: BIER/EO gas vessels, cardiovascular implants, blood pressure transducers and cardiac defibrillator devices 
    • Sterilization

    Benefits:

    • Standards are globally applied 
    • Standards developed through international bodies such as ISO, IEC and ITU 
    • Standards based on published, peer-review studies 
    • Standards allow for technology changes/innovations 
    • AAMI standards assure compliance

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