Medical Device EMC Testing Services
Medical Device EMC Basic Standard
IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests)
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.
SGS Provides the Latest Version of Medical EMC Standard Services：IEC 60601-1-2:2014 + A1:2020
The previous edition of the medical device EMC standard IEC 60601-1-2:2014 (Edition 4.0), was published in 2014, and the latest edition: IEC 60601-1-2:2014+AMD1:2020 (Edition 4.1) was published in September Sep. 2020. Many of countries/regions authority will also require this new version for EMC testing. In response to this demand, SGS has already lunched the services in advance.
Main Changes of the New Version
The new version standard still emphasizes that medical equipment, its electromagnetic interference should not damage other equipment and should also be able to withstand electromagnetic interference from other equipment used in the same environment and covers home/professional/special various medical healthcare environments.
The main changes are as shown below：
- For CISPR 11 Conducted Emission test, the minimum and maximum RATED voltages are required if the voltage difference of RATED input voltage range is greater than 25 %.
- For IEC 61000-4-6 Conducted immunity test, Signal I/O port whose maximum cable length is less than 1 m are excluded. (3 m for previous version)
- Considering the risks associated with a variety of closely proximity radiated magnetic fields (RFID, electromagnetic cooking appliances…) in the medical environment, test methods as described in IEC 61000-4-39 are used to apply on ME EQUIPMENT and ME SYSTEMS with the proximity to the frequency range from 9 kHz to 13.56 MHz Magnetic field resistance test requirements.
SGS EMC Laboratory
SGS EMC Laboratory has totally 7 service locations in Taiwan. In medical EMC fields, we provide complete and diversity testing / certification solutions, from information, wireless, wearable to automotive medical devices. We help manufacturers to meet market needs and buyers’ requirements of testing and certification services. Those services include：
- IEC/EN 60601-1-2： Medical device EMC general requirements
- IEC/EN 60601-2-XX： Medical device particular requirements
- IEC/EN/ISO 80601-2-XX： Medical device particular requirements
- IEC/EN 61326 series： Meas., Ctrl., Lab use/IVD device EMC requirements
- ISO 15197： IVD－Blood-glucose monitoring systems
- EN 12184, ISO 7176-XX： Medical EPW and scooter EMC requirements
- AAMI TIR69： RM of wireless coexistence medical devices
- AIM 7351731： RFID immunity test for medical devices
- ANSI C63.27： Evaluation of Wireless Coexistence
Contact with below SGS EMC Laboratories for Medical EMC testing, Certification and Total solution services.
