The appendix in the back of UL 498 that details hospital-grade plugs does not list NEMA 1-15 as being approvable as a hospital-grade component. I believe part of the reason stems from the fact that part of the criteria for achieving hospital-grade status involves protecting the ground connection, which automatically disqualifies the NEMA 1-15 styles. UL 60601 does in fact have provisions for Class II equipment, but these requirements are substantially different from Class I requirements. The same can be said regarding the construction of Class I and Class II plugs in general, which also does not lend itself to adapting the 1-15 plugs to Class I hospital-grade requirements. At this time, I cannot say how plugs for Class II devices are handled by the agencies and equipment manufacturers. It is almost certain that they are using either standard NEMA 1-15 plugs or that somebody is making a more durable version that is being allowed for use on such equipment.  For an answer to this question, we would recommend you speak to a UL engineer whose area of product expertise is medical equipment approval.

I am quite sure a NEMA 1-15 could be developed to meet the requirements of a Class II plug and the requirements of UL 60601, but it could not be designated hospital grade or marked with a Green Dot without a standard change. I would think that the construction of such a plug would need to follow the double insulation criteria for Class II items, as well as have a beefier, more durable construction than most NEMA 1-15 styles on the market (similar to Class I hospital-grade plugs).

Based on my reading of Directive 1999/44/EC on the sale of consumer goods and associated guarantees, although warranty lengths vary in different countries of the European Union, two years is typical. If the customer has an issue with something that is not in conformance with the contract (the product is not to spec, for example, or requires repair) within the first two years, the process is to deal with the seller only. The seller can then “pursue remedies” with the manufacturer. Therefore, if the manufacturer is selling a piece of equipment that is then sold on in Europe, the (re)seller has to deal with the issue but the manufacturer may have some level of liability, too. This does not apply to my company Interpower, as we do not sell a piece of equipment, only the components that are part of it.

We distinguish four areas of the world when it comes to medical-grade standards or preferences: North America (the United States and Canada), Australia, Denmark and Japan. All other countries will accept the standard power cord or cord set for use in medical facilities.

In North America, any cord used with medical (or “patient-care”) equipment must be hospital-grade and it is the plug, subject to particular requirements, that gives the cord this classification. These requirements are contained in the following standards: medical equipment standards UL 60601-1 and CAN/CSA C22.2 no. 21; power supply cords standard UL 817 and CAN/CSA C22.2 no. 21; and attachment plug standards UL 498 and CAN/CSA C22.2 no. 42.

The hospital-grade pin pattern conforms to the NEMA 5-15 standard. However what makes the product medical-grade is the importance placed upon the reliability of the ground, or earth, connection in order to protect patients and medical staff.

To achieve medical-grade standards:

• the ground, or earth, pin must be solid instead of folded brass
• the blades need to be nickel-plated
•  the plug body must include an internal cable retention device to prevent stress to the internal connections.

North American hospital-grade cords, cord sets and rewireable plugs and sockets will carry the “green dot,” signifying that they have been designed and tested for grounding reliability, assembly integrity, strength and durability. Clear plugs are often specified, allowing for the internal connections to be visibly checked. However, there is no mandate from UL or CSA that they must be used. Grey is a common colour for medical-grade cords in North America. It is not necessary to use the traditional white, green and black primary conductor colours in the North American cable used in a cord set assembly. In order to aid engineers and assemblers from countries that use the colour-coding found in harmonised cable, the U.S. and Canadian national electrical codes now allow brown, blue and green/yellow primary insulation as long as the cable is still manufactured to UL and CSA standards.

Danish hospital-grade cords are recommended for use in medical applications, and specifications have been added to the standard SB 107-2-D1. The socket is designed to prevent connection with “normal equipment” and disrupting the mains circuit in specific medical settings.

In Australia, the use of orange cable and clear plugs is preferred but there are no specific standards related to a medical-grade classification. The assembly of the cord and the component pieces are the same as the standard power cord.

Japanese hospital-grade cords recommended for use in medical applications and specifications have been added to the standard JIST 1021. Cosmetically, general and hospital-grade cords will look the same; hospital-grade cords, however, are required to be tested to this higher standard.

As stipulated in UL 60601-1, medical-grade, North American socket strips must carry a cover for each of the hospital-grade outlets. These covers can only be accessible with the use of a tool to prevent use of the outlet with non-medical-grade equipment. Each outlet should display the green dot that signifies it has been designed and tested for grounding reliability.

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