Food and Drug Administration Announces Modifications to List of Recognized Standards

(ANSI: New York) -- The U.S. Food and Drug Administration 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 and the International Electrotechnical Commission.

Modifications to the “List of Recognized Standards, Recognition List Number: 019” include nearly 100 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 20 newly recognized standards. A searchable database of the current list—including nearly 150 U.S. national standards—is maintained on the FDA web site.

The “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, “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, this document has been adopted as an international standard by ISO.

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

• IEC 61223-3-2 Ed. 2.0 b, “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 62B, “Diagnostic imaging equipment,” the standard addresses image quality, dose, and equipment safety.

• ISO 11810-2, “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 172/SC 9, “Electro-optical systems,” this standard helps to test and classify surgical drapes and protective covers with respect to laser-induced hazards.

For more information, visit www.ansi.org/news_publications/news_story.aspx?menuid=7&articleid=1697

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