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Food and Drug Administration Announces Modifications to List of Recognized Standards


New York, Jan 02, 2008

The U.S. Food and Drug Administration (FDA) recently issued an updated list of consensus standards for use in evaluating medical devices before they are approved by the agency for market entry.

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 ANSI-accredited standards developing organizations 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: 019 include nearly one hundred changes to the FDA’s roster of accepted standards. In addition to the withdrawal and/or revision of previously accepted documents, the updated list adds twenty newly recognized standards. A searchable database of the current list – including nearly one hundred fifty American National Standards – is maintained on the FDA website.

The standards identified in Recognition List Number: 019 evaluate the safety and performance of an array of medical devices, ranging from anesthetic equipment and surgical drapes to microlens arrays and contact lenses. Newly recognized standards include the following:

ANSI/AAMI/ISO 11140-5:2007, Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests

Developed by ANSI member and accredited standards developer the Association for the Advancement of Medical Instrumentation (AAMI), this document has been adopted as an International Standard by ISO.

The standard provides performance requirements for certain air removal indicators during the pre-vacuum phase of steam sterilization cycles.


IEC 61223-3-2 Ed. 2.0 b:2007, Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment

This International Standard outlines test methods to measure the effectiveness and performance of mammographic X-ray equipment and devices.

Developed by IEC Subcommittee (SC) 62B, Diagnostic imaging equipment, the standard addresses image quality, dose, and equipment safety. The Medical Imaging Technology Alliance (MITA) is the USNC-approved U.S. TAG Administrator to SC 62B.


ISO 11810-2:2007, Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 2: Secondary ignition

Developed by ISO Technical Committee (TC) 172/SC 9, Electro-optical systems, this International Standard helps to test and classify surgical drapes and protective covers with respect to laser-induced hazards.

ANSI member and accredited standards developer the Optics and Electro-Optics Standards Council (OEOSC) is the ANSI-Accredited U.S. TAG Administrator to TC 172.


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

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