Safety Agency Mark – Is it required for medical electrical equipment?
This article explains when a safety agency mark is required for electrical medical equipment for products sold in the USA.
What is a safety agency mark?
Examples of a safety agency mark include UL, CSA, Intertek, SGS Q-mark, and other marks indicating that a recognized testing lab completed the electrical safety testing, and the device passed the testing. Health Canada requires a safety agency mark to certify approval by a lab that is accredited by the Standards Council of Canada (SCC). However, device manufacturers are frequently unclear what the requirements are in the USA for electrical medical equipment regarding a safety agency mark.
Leo Eisner’s explanation of the requirements for a safety agency mark in the USA
Leo Eisner of Eisner Safety was kind enough to answer this question. The simple answer is yes. In the US, there is a requirement for equipment in the workplace to have an NRTL Safety Agency Approval Mark for the applicable category on the device to meet OSHA requirements. The requirements for NRTL approval of electric equipment (or medical electrical equipment) are in 29 CFR 1910.303(a) and 29 CFR 1910.307(c). Because of these requirements, most electric equipment used in the workplace must be NRTL approved. Biomeds maintain and track all the medical equipment in hospitals and clinical environments, and the biomeds usually insist upon an Agency Approval Mark. However, the biomeds may not be aware of the NRTL requirements.
What is an NRTL?
An NRTL is a Nationally Recognized Test Lab that is approved or authorized by Occupational Safety & Hazard Administration (OSHA) for specific device test standards (i.e., UL 60601-1 [National deviation version of IEC 60601-1, 2nd ed. medical electrical equipment standard] and / or AAMI ES 60601-1 [National deviation version of IEC 60601-1, ed 3.1], among many other standards) to allow a US Mark to be placed on approved devices that meet the applicable standard. Not all NRTL labs can test to the listed medical electrical standards for medical electrical equipment to allow a US mark to be placed on devices. You need to go to the OSHA NRTL site to verify that the test lab can issue a US mark. Within the lab’s link, you can find which standards each test lab is allowed to issue US Marks for.
Posted in: IEC 60601Leave a Comment (3) ↓
Hi. Thanks for that useful information. My question is how this applies to Medical Electric Equipment that are only used in the home by “lay” users i.e. not physicians etc. As this is not a work place and are used by consumer would the NRTL mark requirement still apply? I would expect not
Oregon State also has a specific Law that requires all equipment used in hospitals to be NRTL tested.
Information is that this came about because of several hospital fires that were the result of non NRTL rated equipment.
Thank you for sharing that Brandon. OSHA requirements and individual State requirements vary, but NTRL testing is a typical requirement for hospitals in every state, whether state-mandated or not.