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Food and Drug Administration Publishes Revisions to List of Recognized Standards

New York, Sep 15, 2008

The U.S. Food and Drug Administration (FDA) has issued new revisions to its list of accepted standards for use in premarket reviews of medical devices.

The Food and Drug Administration Modernization Act of 1997 authorized the FDA to recognize voluntary consensus standards developed in an open and transparent process, such as those developed by organizations accredited by the American National Standards Institute (ANSI), as well as the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).

Modifications to the List of Recognized Standards, Recognition List Number: 020 contains both modified existing standards as well as new additions to the list of accepted standards. A total of 32 documents were added to the list in the fields of biocompatibility; cardiovascular/neurology; dental/ear, nose, and throat; general hospital/general plastic surgery; in vitro diagnostic; materials; OB-GYN/gastroenterology; ophthalmic; physical medicine; and sterility.

A searchable database of the current list – including nearly one hundred fifty American National Standards – is maintained on the FDA website. Newly recognized standards include the following:

ISO 22112:2005, Dentistry -- Artificial teeth for dental prostheses

This international standard specifies the classification, requirements, and test methods for synthetic polymer and ceramic teeth that are manufactured for use in dental prostheses.

ISO 22112:2005 was developed by ISO Technical Committee (TC) 106, Denistry, Subcommittee 2, Prosthodontic Matierals. The U.S. holds the chairmanship and secretariat of this SC, with Dr. Kenneth Anusavice serving as chairman and the American Dental Association (ADA) as secretariat. ADA, an ANSI organizational member and accredited standards developer, is also the ANSI-accredited U.S. Technical Advisory Group (TAG) administrator to TC 106.

ANSI/AAMI RD61:2006, Concentrates for hemodialysis

Developed by the Association for the Advancement of Medical Instrumentation (AAMI), an ANSI organizational member and accredited standards developer, this American National Standard specifies manufacturing, labeling and testing requirements for concentrates to be diluted for use as dialyzing fluids in hemodialyzers, machines that remove impurities and waste products from the bloodstream before returning the blood to the patient's body. The requirements established by this standard will help ensure the effective, safe performance of hemodialysis concentrates and related materials.

ANSI/ASME A18.1-2005, Safety Standard for Platform Lifts and Stairway Chairlifts

This safety standard covers the design, construction, installation, operation, inspection, testing, maintenance, and repair of inclined stairway chairlifts and inclined and vertical platform lifts intended for transportation of a mobility impaired person.

The American Society of Mechanical Engineers (ASME), an ANSI organizational member and accredited standards developer, produced this American National Standard for devices with limited vertical travel, operating speed, and platform area, and whose operation is under continuous control of the user/attendant.

For more information or to see the complete list of modified and additional standards, please view the Federal Register notice.

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