Under medical EMC standard IEC 60601-1-2, medical devices are expected to perform according their intended use and remain safe (essential performance & safety). IEC 60601-1-2 defines the basic and essential performance for medical equipment in regard to emissions and immunity to electromagnetic disturbances.
IEC 60601-1-2 applies to the basic safety and essential performance of medical-electrical equipment and medical-electrical systems in the presence of electromagnetic disturbances as well as electromagnetic disturbances emitted by medical-electrical equipment and medical-electrical Systems.
IEC 60601-1-2 4th Edition introduced significant technical revisions such as risk management, risk analysis and changes to immunity requirements. These significant changes include specification of immunity test levels according to the environments of intended use, which are categorized according to locations that are harmonized with IEC 60601-1-11: the professional healthcare facility environment, the home healthcare environment and special environments.
MET is the first NRTL approved by OSHA for medical equipment. OSHA regulations cover all workplaces, which include hospitals, clinics, therapy centers, and similar facilities. MET-certified medical products have been universally accepted in the US and Canada.
Our Medical EMC Testing & Certification capabilities »
Medical EMC testing performed by MET is typically to EN/IEC 60601-1-2 for most devices. Additions and/or deviations to the requirements of 60601-1-2, as published in the appropriate EN/IEC 60601-2-XX for particular devices, may also be applicable.
- ANSI ISO 14708-3 – Implants for surgery – Active implantable medical devices – Part 3: Implantable neurostimulators
“I thank you for your hospitality and usual excellent service during my visit for surge immunity testing of our MC-6A Electrosurgery Unit, 220 Volt version, last Thursday. It was a very pleasant experience and you can count on me to recommend MET Labs to others at every opportunity I have.
We will again be requiring testing services fairly soon for a couple of new projects that we intend to develop and manufacture. With the very good relationship that we have with you, at MET Labs, we won’t even be tempted to look elsewhere.
Again, thank you for – unlike your business competition – making safety testing a nearly painless process.”
Dennis Karol, Production Supervisor & QMS Implementer
Macan Manufacturing Company