The U.S. Food and Drug Administration (FDA) has updated its list of recognized international and national standards that can be used to demonstrate compliance with certain requirements for premarket review and authorization of medical devices.
In a Notice published in the Federal Register in mid-August, the agency announced more than 40 additions and modifications to the list of FDA Recognized Consensus Standards. Notable among the new standards added to the list is the addition of ISO 80601-2-87, which details safety and essential performance requirements for high-frequency ventilators, and IEC 62563-2, which addresses acceptance and constancy tests for medical image displays.
Also newly added to the list of recognized standards is ISO 17664-2, which covers information to be provided by medical device manufacturers for the sterilization of non-critical medical devices.
Read the FDA’s Notice regarding its modification to the list of recognized standards.
Leave a Reply