Designing, Building, and Maintaining Hospital‑Grade Products
When designing, building, and maintaining hospital-grade products, it’s crucial to know if there are medical standards or other requirements in the country the product is being used.
Medical Standards in North America
In North America, hospital-grade products used within the operating room and throughout the hospital need to follow the requirements contained in UL and CSA standards. The following briefly describes requirements found within these standards—UL 817, CSA C22.2 no. 21, UL 498, and UL 60601-1.
Molded-on Attachment Plugs and Connectors
For hospital-grade molded-on attachment plugs and connectors, the UL 817 and CSA C22.2 no. 21 requirements are applicable to the following NEMA configurations: 5-15, 5-20, 6-15, and 6-20. The blades on the plug shall be of solid brass material and the grounding pin cannot be easily bent or removed. (Note: CSA also allows a 1-15 which is an ungrounded plug with no ground pin.) Both the plug and connector need to be a straight or a right-angle type and molded onto flexible cord. Both need to be marked hospital-grade with a green dot. Similar requirements are found in UL 498.
Power Supply Cords
The type of flexible cord that is to be used on hospital-grade power supply cords is SJO, SJT, SJTO, SVO, SVT, SVTO, or other jacketed type cord of equal or harder usage, per UL 817. The conductor size is 18, 16, 14, 12, and 10 AWG.
Hospital-Grade Extension Cords
The type of cord to be used for the hospital-grade extension cords includes SJO, SJT, SJTO or other jacketed type cord of equal or harder usage. The conductor size is 16, 14, 12, and 10 AWG. UL 817 states that, “A hospital-grade extension cord set shall have a maximum length of 15 feet.” (This cord uses a NEMA plug with a NEMA connector.)
Hospital-Grade Cord Sets
A hospital-grade cord set needs to have plugs that meet the above requirements and connectors that meet IEC 60320-1 requirements or another non-NEMA approved configuration. The conductor size is 18, 16, 14, and 12AWG.
UL 60601-1 gives specific definitions of patient care equipment (intended for use in the patient vicinity) and patient vicinity (areas where patients are normally cared for). It also gives requirements for “hospital-grade” or “hospital only” plugs and cords.
Medical equipment needs to meet the AS/NZS 3200 standard. There are no special requirements for plugs, only preferences. All Australian plugs must be approved to the AS/NZS 3112 standard. In Australian medical applications, it is preferred by some hospitals to have a clear plug with an orange, flexible cable.
There are Danish hospital-grade plugs and sockets that are recommended for use in medical applications. The socket is designed to prevent “normal equipment” from being connected and disrupting the mains circuit in specific medical settings. For select medical facilities in Denmark red is the preferred color.
Hospital-grade plugs and outlet-sockets need to be approved in accordance with JIS T 1021. Each shall be indelibly marked with an “H” and for plugs, a green dot is allowed. Hospitals have specific preferences when using hospital-grade plugs and sockets.
Meeting Hospital-Grade Needs
At Interpower, an extensive range of clear, black, and gray plugs are available as are custom cable lengths. Value-added services include custom labeling and packaging and made-to-order assemblies.
Interpower offers free technical support. For further assistance, please see Interpower’s contact information below.
North American standards: UL 817, CSA C22.2 no. 21, UL 498, UL 60601-1
Japanese standard: JIS T 1021