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
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.
Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance
Medical electrical equipment Part 1-1 - Collateral Standard: Safety Requirements for Medical Electrical Systems
Medical Electrical Equipment PART 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility
Medical electrical equipment Part 1-3: General Requirements for Radiation Protection in Diagnostic X-Ray Equipment
Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
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
Medical electrical equipment Part 1-9: General requirements for basic safety and essential performance – Collateral Standard: Requirements for environmentally conscious design
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
Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories