Given the stakes they operate in, medical computers are some of the most closely regulated objects in the world. Major nations have a vested interest in ensuring the equipment healthcare providers use is safe, both for the patient and the end-user. They are more than willing to use their regulatory power to do so.
However, this creates a web of overlapping regulations that medical device manufacturers must meet before they can sell their products in those nations. In today's article, we'll break down some of the significant healthcare markets worldwide and what medical device regulations they implement.
IEC 60601-1: The International Standard
For the purposes of this article, it helps if we start with the internationally agreed-upon standard and then work from there. The first and most important standard for medical devices is the International Electrotechnical Commission's IEC 60601-1. This standard regulates the basic safety parameters for medical devices and medical computers, mainly how they protect the user and patient from electrical shocks.
However, different nations have different priorities when it comes to safety concerns. Therefore, countries often use IEC 60601-1 as a basis for their safety standards but add deviations or extra regulations to reflect these concerns. For an easy example, we'll start with the United States and UL 60601-1.
United States and UL 60601-1
UL 60601-1 is the U.S. national standard derived from IEC 60601-1. The largest key difference between the two standards is UL 60601-1's emphasis on fire safety. This is because many buildings in the United States are made from wood and are more susceptible to fire. Many of the IEC's members are European nations, where buildings are primarily made from brick and stone. The result is that American fire safety codes must be higher than their European equivalents.
Therefore, a significant concern in UL 60601-1 is the flammability of polymeric enclosures and covers to ensure that if an electrical short occurs, the casing of a medical device won't catch fire and spread. There are also different requirements for transportable equipment and stationary equipment. Additionally, fire resistance requirements are unnecessary if the fire enclosure is sourced by circuits with less than 15 W in power.
Lastly, enclosure mechanical abuse tests are performed to ensure that the enclosure doesn't expose live parts or cause a fire, electrical shock, or mechanical hazard.
Australia and AS3200.1.0
Australia's deviations from the IEC 60601-1 medical device regulations are contained in AS 3200.1.0. These deviations include both language and safety requirement changes.
On the language front, AS 3200.1.0 refers to AS standards rather than IEC standards. For example, AS3200.1.0 medical device regulations refer to AS 1939 instead of IEC 60529 for the degrees of protection provided by an enclosure.
Additional safety standards are also included in Australia's regulations. Gas connections are a major addition; AS3200.1.0 requires that gas cylinders be clearly marked to denote their contents to ensure healthcare providers are not confused by which gas is in which cylinder.
Another primary safety concern for AS3200.1.0 is ceiling-supported equipment. Any devices mounted from the ceiling must include anti-crash devices, brakes, or stops, and the means for inspecting cables, anchorages, locknuts, and more.
Canada and CSA C22.2 No 601.1
Canada deviates from IEC 60601-1 with CSA C22.2 No 601.1. This standard is partially based on the Canadian Electrical Code and helps clarify certain issues by adding editorial notes to make the requirements of IEC 60601-1 more clear.
For example, one of the tests conducted under IEC 60601-1 is the rub test, which ensures that no markings on the device will be damaged by cleaning agents or disinfectants. The Canadian standard specifies that the methylated spirits used in this test must comprise 90% ethanol, 9.5% methanol, and 0.5% pyridine.
Another major concern for Canada is bilingual labeling and documentation. Clause 6 of C22.2 mandates that all equipment safety instructions or documents must be in both French and English to ensure they can be used in the country's Anglophone and Francophone regions.
Japan and JIS T 0601-1
Japan's JIS T 0601-1 standard features two major differences from IEC 60601-1. The first concerns power cords: Japan permits alternative colors (such as white and black) to the international standard color (blue and brown) for the conductors of power cords. It also restricts the use of vinyl cord if a metal enclosure is exposed to 60 degrees Celsius or higher.
Another significant difference is that JIS T 0601-1 does not require an enclosure leakage current measurement to be taken with mains voltage applied to the signal input or output parts. In simpler terms, this test is to see if accessories connected to the medical-grade computer or device in question will fail at mains power. The Japanese medical device regulation takes a more realistic approach by mandating that devices attached to the signal input and output ports must comply with IEC standards.
Conclusion
With an increasingly globalized economy, medical tablet and computer manufacturers are positioned to take advantage of markets around the world. However, these manufacturers must be agile enough to adapt their devices to the various national-level regulations these markets implement.
If you're in need of a medical computer manufacturer that can meet international and national regulations alike, turn to the experts at Cybernet Manufacturing. Our design and engineering expertise allow us to adapt our medical-grade PCs and tablets to various regulatory requirements. Contact our team today, and we can help you find the perfect medical computer for your healthcare group's needs.
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