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Hospital-grade power cord requirements for power cords and other power system components for the global market

While many countries have standards for overall medical equipment, some countries have related component requirements (such as plugs and cords). For countries that do have hospital-grade or medical application standards on components, it is important to know what the requirements are in order to comply with that country or region’s regulations.

Countries/regions that have hospital-grade or medical application standards on specific components include Australia/New Zealand, Denemarken, Japan, and North America. Power cords and power cord kits, as well as plugs and receptacles, should comply with special regulations. With the exception of these regions, there is no difference between plugs, receptacles, and cords used in medical environments and those used in non-medical environments.

echter, certain countries/regions have standards for overall medical equipment that differ from specific components.
Medical applications in Australia / New Zealand

Medical equipment must comply with the AS / NZS 3200 standaard-.

There are no special requirements for plugs, only preferences. All Australian plugs must be approved by AS / NZA 3112. In Australian medical applications, some hospitals prefer to use clear transparent plugs and orange flexible cables. These plugs and connectors must have one of many Australian approvals. If you are exporting to Australia or New Zealand, you should contact the end customer for guidance.

Danish hospital grade power cord requirements

Danish hospital grade power cord requirements and sockets are recommended for medical applications and specifications according to standard S.B. 107-2-D1. The sockets are designed to prevent the connection of “conventional equipment” in specific medical settings and to break power circuits. Some hospitals may prefer a flexible red cord, but this is not a requirement of the standard.

Japanese hospital grade power cord requirements

DENAN is a mandatory national law administered by the Japanese Ministry of Economy, Trade, and Industry. Wires, stekkers, and sockets must carry the PSE approval mark. The PSE mark is the minimum legal requirement for plugs. If you want to sell your plugs as “hospital grade,” you can perform the internal testing required by JIS T1021 and declare yourself as “hospital grade” in accordance with JIS T1021.

Informative reports. In aanvulling, you may be able to obtain the JIS Mark when your product and plant meet the JIS requirements. You will need to submit to a Japanese testing laboratory that is accredited by METI for the JIS Marking System.

North American hospital grade power cord requirements

hospital grade power cord requirements plugs, receptacles and cable mount connectors are subject to special requirements in the following standards: Medical Equipment Standard – de 60601-1 and CAN / CSA C22.2 no. 21; Power Cord Standard – de 817 and CAN / CSA C22.2 no. 21; and Plug and Receptacle Standard – de 498 and CAN / CSA C22.2 no. 42. . 42. Hospital-grade plugs with diameters conforming to NEMA WD-6 and UL 817 mm scheiding van de pinnen en de pinnen.

(1) Blades must be solid, not folded brass.
(2) Inserts are normally nickel-plated.
(3) Plugs include an internal cable retainer or strain relief to prevent any stress on the plug’s internal connections.
(4) NEMA plugs and receptacles are marked “hospital grade” with a green dot.

Specifically, they must meet the requirements of UL 498 and UL 60601, including abrupt plug withdrawal, ground pin retention, fault current, terminal strength, grounding temperature and resistance, assembly safety, flex clip strain relief, and flex pull, and various durability and impact material tests.

North American hospital grade power cord requirements must use NEMA plugs with a “green dot” indicating they have been designed and tested in accordance with UL 817 and CAN / CSA C22.2 no. 21 as hospital-grade power cords and power cord kits. Kits. Specifically, de 60601-1, Sections 57.2 en 57.3 require that “patient care equipment” used “in the vicinity of the patient” must use hospital-grade accessories. Defines “patient care equipment” en “near the patient.”

Currently, de 498 en 817 standards only allow NEMA 5-15, 5-20, 6-15, en 6-20 straight blade equipment to be labeled as “hospital grade.” CSA will allow NEMA 1-15 if double insulated and meets the requirements.

International Conductor Color Coding

It is recommended that power cords containing international brown, blauw, and green/yellow conductor color codes be used in place of the traditional North American black, white and green conductor color codes. In standardizing the international color-coding system, it will simplify the connection of various country/region-specific power cords to equipment prior to export (including export to the U.S.). The U.S. and Canadian National Electrical Code, as well as U.L. and CSA standards, allow the use of IEC brown, blauw, and green/yellow conductor color coding.

When selecting hospital grade power cord requirements input modules and other components used in medical devices, special medical requirements are important for convergence and filtering. Medical devices connected to patients may be subject to low leakage current requirements. A low leakage filter in the 5 μA range at 250 VAC is desired. In aanvulling, it may be necessary to fuse both the line and neutral connectors (Type H-stekker behoort tot de gevaarlijkste ter wereld, double fusing).

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