Electrical and Electronic Medical Devices and equipment are required to meet Electromagnetic Compatibility specifications required by the FDA in the United States, Health Canada in Canada, and by law under the Medical Device Regulations 2017/745 and 2017/746 in the European Union. These Electromagnetic Compatibility requirements include both emissions and immunity and vary on their levels of stringency depending on the intended use of the medical equipment, primary locations for its use, and the intended operators or patients that will be using, operating, or be in contact with medical devices and equipment. Most standards for medical devices and equipment are based on the IEC/EN/ISO 60601-1-2, currently in the 4th edition.
Several collateral standards have been established to add specific testing applications based on these specific features or intended uses. The collateral standards are in addition to the basic requirements found in IEC/EN/ISO 60601-1-2. Most test programs include requirements found in collateral or ancillary standards, which can include product safety requirements as well.
D.L.S. supports Medical Device and Equipment testing to the current 60601-1-2 and other collateral or ancillary standards for specific applications. The current regulations require the inclusion of accessories and support equipment that make up a system or apparatus and is placed onto the market by the manufacturer. Medical devices and equipment that include an inherent enabled wireless function, transmitter or receiver, may have to include testing to wireless regulations and standards, in addition to medical device requirements.
D.L.S. has the technical expertise to assist in the development of a formalized test plan that clearly identifies the standards and testing needed to meet the global requirements for medical devices and equipment. A detailed examination of previous testing as part of a transitional analysis can often times reduce the type of testing needed, and the stringency levels to be meet for changes to existing products already on the market.
Contact D.L.S. today to review your medical devise and equipment to determine the best possible compliance path.
IEC 60601-1-2:2014 EMC Medical, 4th Edition
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
AIM 7351731 RFID Exposure Immunity
Medical Electrical Equipment and Systems: Electromagnetic Immunity Tests for RFID Readers
ISO/IEC 60601-1-11:2015 Medical Compliance Home Health Care Items
Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
ISO/IEC 60601-2-10 Ed. 2.1 b:2016 Nerve and Muscle Stimulators
Medical electrical equipment – Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
ISO/IEC 60601-1-6:2010 Usability
Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
ISO/IEC 60601-1-8:2006 Alarms
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
D.L.S. also offers Medical Product Safety testing.