EMC Testing for Health Care & Medical Devices. Electromagnetic Compatibility and Electrical Safety Laboratory.

New medical electronic/electrical equipment contributes to more effective healthcare and a better quality of life for all of us. Healthcare technology innovation has a positive impact on our future generations, but it also poses significant challenges to manufacturers and designers in terms of EMC and electrical safety compliance.

The primary compliance requirements for medical devices across various markets include electromagnetic compatibility (EMC) and electrical safety. The fundamental standard in use, with its latest revision, is IEC 60601. Initially published in 1977 as the general standard for medical devices’ safety and essential performance, IEC 60601 has undergone numerous revisions and is widely acknowledged as a benchmark standard.. IEC 60601 consists of over 10 collateral and over 80 standards, it has been adapted by many countries around the world. For the European Union it was EN 60601, for the USA UL2601-1, for Canada it was CSA C22.2 and for Australia and New Zealand it was AS/NZ 3200-1.

The third edition of IEC 60601-1 was published in 2005. The United Sates adapted it in the same year and European Union adapted in 2006. The most important addition to the third edition was risk management and the concept of essential performance.  FDA recognized 60601-1-2 Edition 4 was adapted in 2018 for the US market. The Edition 4 covers all the needed EMC requirements for the US market.  Medical devices were required to comply with the 4th edition of IEC 60601-1-2 by December 31, 2018, for Europe, the United States, and Canada.

The European Union’s Medical Device Regulation known as EU MDR directive 2017/745 was published in the Official Journal in April of 2017. It supersedes the Medical Devices Directive 93/42/EEC and Active Implantable Medical Devices Directive 90/385/EEC.

Wireless Medical Devices

In addition to this, wireless devices are becoming more prevalent in the medical industry. Therefore, the FDA’s guidance of Radio Frequency Wireless Technology in medical devices must be followed. It can be over whelming with many medical technologies, directives, and hundreds of standards for any manufacturer. This is where you can count on QAI’s team of experts to help you navigate the best path for your compliance needs. On top of the technical standards, manufacturers must follow quality management standards like ISO 13485 and FDA 21 CFR 820.30. These two standards refer to the management system guidelines and processes to be followed by the manufacturer.

QAI is a Telecommunication Certification Body for the US and Conformity Body for Canada. Under one roof, at QAI’s state of the art facilities, you can accomplish the testing and certification of wireless radios for the medical devices, the testing of medical devices by themselves, and FDA’s wireless coexistence testing and electrical safety testing.

QAI’s knowledgeable engineers will help you navigate the path to compliance in an efficient, friendly and professional manner so you can get your product to market as efficiently as possible.

Why Choose QAI for Medical Electrical Device Compliance?

To certify medical devices to the IEC 60601 standard involves ensuring compliance with specific electromagnetic compatibility (EMC) and safety requirements. We will continue into the description of certifying medical devices for the electrical safety as well. It will have all the details in the electrical safety department.

QAI is recognized and holds accreditations from various organizations specific testing, inspection, and certification activities, including: Occupational Safety and Health Administration (OSHA) in the USA as a Nationally Recognized Testing Laboratory (NRTL) and the Standards Council of Canada (SCC) as a certification body. We are also a Certification Body Testing Laboratory (CBTL) under IECEE CB Scheme. QAI’s EMC Lab is accredited by A2LA to ISO/IEC 17025 and registered with FCC, Innovation, Science and Economic Development (ISED) Canada and many other international government bodies. Please visit our accreditations page for details of how we can support in bringing your product to the global market.

QAI follows strict international standards to ensure testing is performed accurately and by knowledgeable staff. QAI will work with you to develop a test plan upfront covering the performance, compatibility, EMC and electrical safety compliance requirements so you know exactly what to expect and the associated costs. We believe in transparency, honesty and being responsive to our clients.