U.S. FDA Modifies List of Recognized Medical Device Standards

January 14, 2008 // Published as a news service by IHS

The FDA Modernization Act of 1997 authorized the FDA to recognize voluntary consensus standards developed in an open and transparent process, such as those developed by American National Standards Institute (ANSI)-accredited standards developing organizations (SDOs), 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 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 American national standards, is maintained on the FDA web site.

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:

• 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 the Association for the Advancement of Medical Instrumentation (AAMI), this document has been adopted as an international standard by ISO. It 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 U.S. National Committee (USNC)-approved U.S. technical advisory group (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. 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, see the Federal Register notice at http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/E7-24580.htm.

Source: American National Standards Institute (ANSI).