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Medical Electrical Equipment (IEC TRF)

Medical electrical equipment standards are published by IEC and are included in test report forms, which are documents prepared by a National Certification Body to include all the information to document a test or analysis. Test report forms (TRF) are designed to be easy-to-use and fully in-line with the associated IEC standard document. This collection of TRFs features the IEC 60601 series, which spans hundreds of safety, best practices, and testing topics and procedures invaluable to anyone in the medical field.

Topics include basic safety and practices, x-ray equipment, electron accelerators, surgical equipment, environmentally conscious design, alarm systems, and electrical systems


IEC 60601-1 / IECEE TRF 60601-1 - Medical Electrical Equipment TRF Set

 IEC 60601-1 / IECEE TRF 60601-1 - Medical Electrical Equipment TRF Set (Save 23% off List Prices)

Access the suggested requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. The IEC 60601-1 / IECEE TRF 60601-1 - Medical Electrical Equipment TRF Set also includes the Test Report Form that supplies evidences and the results of the tests and analysis made on a product.




IECEE TRF 60601-1-2 Ed. 9.0 en:2020

This Test Report Form applies to: IEC 60601-1-2:2007

Medical Electrical Equipment PART 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility





IECEE TRF 60601-1-8 Ed. 8.0 en:2020

This Test Report Form applies to: IEC 60601-1-8:2006, AMD1:2012, AMD2:2020 for use in conjunction with IEC 60601-1:2005, AMD1:2012, AMD2:2020

Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems



IECEE TRF 60601-2-1 Ed. 8.0 en:2021

This Test Report applies to: IEC 60601-2-1:2020 for use in conjunction with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012

Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV


IECEE TRF 60601-2-2 Ed. 9.0 en:2021

This Test Report Form applies to: IEC 60601-2-2:2017 for use in conjunction with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012

Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories


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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

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