ANSI - American National Standards Institute
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FDA Issues List of Recognized Consensus Standards for Medical Devices

New York, Apr 14, 2006

The U.S. Food and Dug Administration (FDA) recently issued an updated list of consensus standards recognized by the agency for use in evaluating medical devices before they are approved for market entry. The Food and Drug Administration Modernization Act of 1997 authorized the FDA to recognize 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: 014 includes more than fifty changes to the FDA’s roster of accepted standards. In addition to the withdrawal and/or revision of previously accepted standards, the updated list adds twenty-two newly recognized standards. A searchable database of the current list is maintained on the FDA website.

The standards identified in Recognition List Number: 014 evaluate the safety and performance of an array of medical devices, ranging from medical face masks and examination gloves to radiography equipment and cardiovascular implants. Newly recognized standards include the following:

ANSI/AAMI/ISO 15882: 2003, Sterilization of Health Care Products - Chemical Indicators - Guidance on the Selection, Use, and Interpretation of Results

Developed by ANSI member and accredited standard developer the Association for the Advancement of Medical Instrumentation (AAMI), this document has been adopted as an International Standard by the ISO. The standard describes the selection and use of chemical indicators in medical sterilization processes, and provides guidance in the interpretation of results.

ISO 14243-1: 2002, Implants for Surgery - Wear of Total Knee-Joint Prostheses - Part 1: Loading and Displacement Parameters for Wear-Testing Machines with Load Control and Corresponding Environmental Conditions for Test

This standard defines criteria to evaluate the durability of knee-joint prostheses. An International Standard, the document specifies the applied force, speed, and duration of wear testing, as well as the environmental conditions under which tests should be performed.

ASTM D6978-05, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs

Developed by ANSI member and accredited standards developer, ASTM International, this standard specifies methods to test the resistance of medical gloves to permeation by nine commonly used chemotherapy drugs over a period of extended contact.

ANSI/AAMI/IEC 60601-2-21 Ed. 1.0 b:1994, Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Infant Radiant Warmers

This standard was developed by AAMI to ensure the safety of infant radiant warmers—the systems used in hospital delivery rooms and neonatal intensive care units worldwide to keep newborns and high-risk infants warm and comfortable. This document has been adopted as an International Standard by the IEC.

 Homeland Defense and Security Standardization Collaborative