FDA Issues List of Recognized Consensus Standards for Medical Devices

April 26, 2006

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The U.S. Food and Drug Administration (FDA) updated the list of consensus standards recognized by the agency for use in evaluating medical devices before they are approved for market entry. The FDA Modernization Act of 1997 authorized the agency to recognize standards developed in an open and transparent process.

Modifications to the List of Recognized Standards, Recognition List Number:014 includes more than 50 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 22 newly recognized standards. A searchable database of the current list is maintained on the FDA web site.

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:

• ANSI/AAMI/ISO 15882:2003 - Sterilization of Health Care Products - Chemical Indicators - Guidance on the Selection, Use and Interpretation of Results: Developed by the Association for the Advancement of Medical Instrumentation (AAMI), this document was adopted by the International Organization for Standardization (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 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 the Association for the Advancement of Medical Instrumentation (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 was adopted as an international standard by the International Electrotechnical Commission (IEC).

Source: American National Standards Institute (ANSI).