What are the standards for electrical testing of medical devices:.

Standards for electrical testing of medical devices are critical to ensure product safety, reliability and stable performance. At Tacteasy Epintek, we understand the importance of these standards for medical devices, so our labs are equipped with advanced electrical safety and performance testing equipment, and we strictly follow domestic and international standards for testing. Click on the link to get more suitable medical device solutions

For medical device electrical testing, we mainly follow the following types of standards:

It is a series of standards developed by the International Electrotechnical Commission (IEC), especially the IEC 60601 series of standards related to the electrical safety of medical devices. These standards cover the basic safety and essential performance requirements for medical electrical equipment and provide a globally recognized benchmark for the design and testing of medical devices.

The U.S. Food and Drug Administration (FDA) has established regulations and guidance documents for the electrical safety of medical devices.

The FDA has stringent requirements for the electrical safety performance of medical devices, and our labs are able to conduct testing in accordance with FDA regulations to ensure that our products comply with U.S. market access requirements.

Europe has its own medical device directives and standards, such as the Medical Device Directive (MDD) and the Medical Device Regulation (MDR), as well as harmonized standards. We are also able to conduct testing in accordance with these standards and directives to support the entry of our products into the European market.

In China, we follow the standards and specifications issued by the National Food and Drug Administration (NMPA) to ensure that the electrical safety performance of medical devices meets the regulatory requirements of the domestic market.

At Tacteasy Epintek, we are not only equipped with perfect testing equipment and professional testing team, but also have rich testing experience and cases. We are able to provide our customers with comprehensive medical device electrical testing services, including but not limited to electrical safety performance testing, electromagnetic compatibility testing, electromagnetic radiation testing, and so on. Our test reports are accurate and reliable, and are recognized and trusted by our customers.

We, Tacteasy Epintek, have a clear advantage in medical device electrical testing. With our professional technology, advanced equipment and rich experience, we are able to provide high-quality and high-efficiency testing services to our clients to ensure that the electrical safety performance of medical devices meets the regulatory requirements of both domestic and international markets.