A Comprehensive Guide to Medical Computer Regulations Around The World

Learn about the different regulations around the world that shape medical device design.

Medical devices and computers are some of the most tightly regulated devices in production today. The stakes are too high for them to be otherwise. Developed nations are deeply concerned with ensuring the equipment healthcare providers use is safe for both the patient and the user.

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

The first and most critical standard for medical devices around the world is the International Electrotechnical Commision's IEC 60601-1. This standard is concerned with the safety parameters for medical devices and medical computers and how they protect the user and patient from electrical discharges.

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

The United States implements UL 60601-1 on top of IEC 60601-1. The largest difference between the two is UL 60601-1's focus on fire safety. Most buildings in the United States are built from wood and therefore more vulnerable to fire. Many of the IEC's members are European nations, where buildings are typically made from brick and stone. This means that American fire safety codes must be more stringent than the 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.

Finally, there are mechanical abuse tests for enclosures to ensure they don't expose live parts or cause a fire, electrical shock, or mechanical hazard.

Australia and AS3200.1.0

Australia deviates from the IEC 60601-1 regulations with AS 3200.1.0. These deviations take the form of 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.

AS3200.1.0 also regulates ceiling-supported equipment. Any device attached to the ceiling has to include anti-crash- devices or brakes, and the ability to inspect cables, anchorages, and other mounting devices.

Canada and CSA C22.2 No 601.1

Canada takes IEC 60601-1 and modifies it with CSA C22.2 No6 601.1. Partially based on the Canadian Electrical Code, it helps clarify certain issues and added editorial notes that make IEC 60601-1 requirements 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.

Because Canada is a bilingual nation, Clause 6 of C22.2 requires that all equipment safety instructions and documents be printed in both French and English. This ensures that whether the device is being used in Vancouver, Quebec, or Edmonton, it can be used safely.

Japan and JIS T 0601-1

Japan implements JIS T 0601-1, which has two significant differences from IEC 60601-1. T

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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