The FDA is to Formally Recognize the Medical Electrical Safety Standard IEC 60601-1:2005, 3rd ed
From AAMI March 12, 2010 press release
The U.S. Food and Drug Administration (FDA) will formally recognize the electrical equipment standard IEC 60601-1/Ed.3:2006.
Carol Herman, director of standards at the FDA’s Center for Devices and Radiological Health (CDRH), made the announcement during the Association for the Advancement of Medical Instrumentation (AAMI)/FDA International Conference on Medical Device Standards and Regulation, which took place in Reston, VA, March 9-10.
“We will not only recognize the third edition of the standard, but we will also recognize all collaterals and all particulars,” Herman told attendees.
The third edition of 60601-1 offers general requirements for basic safety and essential performance of medical electrical equipment. It also contains requirements for reliable operation to ensure safety.
CDRH hopes to publish notice of the recognition in the Federal Register by June, Herman said. Once the notice is published, users will have three years to transition to the third edition and the related collaterals and particulars, Herman added.
The standard already has been recognized and harmonized in Europe for the last several years, said Charles Sidebottom, director of corporate standards for Medtronic and secretary of IEC/Sub Committee 62A, which developed the standard.
Sidebottom, who is chair of AAMI’s Board of Directors, says that the subcommittee has been working with CDRH staff to get the standard recognized since well before it was even published. “For us that is a real big deal that the agency formally announced recognition of the whole collection of standards,” he said.
AAMI had adopted its own version of the standard with national deviations called ANSI/AAMI ES60601-1:2005 (IEC 60601-1:2005, MOD), which includes original IEC text where U.S. modifications are introduced for easy comparison of requirements, as well as a number of the collateral and particular standards.
Changes on the Horizon
The CDRH recognition comes as a new amendment to 60601-1 is under development, which includes some changes to the original standard.
One of the proposed changes focuses on extending the scope of 60601-1 to include medical software systems. The amendment includes a definition of medical software systems and associated technical requirements.
The amendment also aims to streamline the application of risk management. It clarifies how a manufacturer should apply the standard’s requirements when evaluating residual risk, Sidebottom said during a presentation at the conference. When there are specific requirements with specific acceptance criteria, compliance is “presumed to establish acceptable risk,” Sidebottom added. The amendment also revises how to establish alternative risk controls or test methods.
The amendment clarifies the definition of essential performance to more fully explain the process for identifying essential performance and mitigating the risks associated with its loss or degradation, said Sidebottom. “Essential performance is performance other than that related to basic safety,” he said. “In many cases, differentiating between basic safety and essential performance is not that important because the standard says both have to be maintained. However, in some cases it is important to draw that distinction so the standard needs to be clearer about how the manufacturer should go about identifying the essential performance.”
The amendment is expected to be published in August 2013.