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The growing complexity of medical devices requires more advanced testing and certification to evaluate compliance with safety and performance requirements.
IEC 60601/80601 is a widely accepted series of standards for the basic safety and essential performance of medical electrical equipment and systems. Noncompliant equipment can pose a significant risk to patients.
Regulatory bodies across key markets often recognize or reference IEC 60601/80601 standards as part of conformity assessment and regulatory approval processes. Compliance with IEC 60601/80601 requirements is widely expected for medical devices in many regions, including the U.S., Europe and parts of Asia, before products can be placed on the market.
Navigating requirements across different markets can be complex due to the varying national deviations and regulatory transition periods worldwide.
To support product launches, medical device manufacturers may choose to engage with an ISO/IEC 17065-accredited product certification body, such as UL Solutions, to help evaluate compliance with current applicable standards.
The IEC published Amendment 2 to IEC 60601-1 in August 2020. With updates to the base standard published, the amendments to the collateral standards followed.
While many updates clarify or correct existing requirements, others may require manufacturers to update designs or documentation.
Clause 8 updates allow certain devices certified to IEC 62368-1:2018 to be used as part of a means of operator protection. The majority of the particular standards have been updated to align with the 2020 version of the Part 1 standard.
For components intended for use in medical electrical equipment, the IECEE Component Certification Program (CCP) supports certification to IEC 60601-1 and IEC/ISO 80601 requirements. This program covers a wide range of medical-related components and subassemblies, including actuators, control boxes, hand controls, flat panel X-ray detectors, and other devices intended to function as part of a larger medical equipment system. Certification is issued as an IECEE Component Certificate of Conformity (CCC) based on evaluation to relevant medical end-product standards using the standard IECEE Test Report Form (TRF).
The test report includes a summary of applicable clauses and defines the scope and limitations of the testing performed. This transparency allows medical device manufacturers to incorporate pre-evaluated components into their IEC 60601 compliance strategy.
Components already covered by dedicated IEC 60601 or IEC/ISO 80601 component or Part 2 standards — such as certain power supplies or regulated accessories — remain outside the scope of the CCP and may instead be evaluated through regular CB Test Certificates (CBTCs). Additionally, components with dedicated IEC standards may also be excluded from the program.
Contact us to learn how the medical CCP can support safer product design, streamlined compliance processes and confidence in IEC 60601 alignment.
UL Solutions testing laboratories in the U.S., Europe and Asia have Certified Body Testing Laboratory (CBTL) status to deliver testing services related to IEC 60601/80601 series of standards.
UL Solutions leverages decades of technical, regulatory and clinical expertise to help manufacturers navigate evolving compliance expectations and support market access efforts.
Our testing and compliance engineers work closely with standards committees — including the American National Standards Institute (ANSI), the Association for the Advancement of Medical Instrumentation (AAMI) and the International Electrotechnical Commission (IEC) — to stay up to date on new amendments and upcoming changes.
UL Solutions has several U.S. Food and Drug Administration (FDA) Accreditation Scheme for Conformity Assessment (ASCA)-accredited testing laboratories across the U.S., Europe and Asia.
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