What are the standards for medical harnesses? What are the specific standards?

Medical wiring harness refers to the electrical wiring harness system used in medical equipment and medical devices. Due to the special nature of medical equipment, medical wiring harnesses need to meet specific standards and specifications to ensure their safety, reliability and compliance with the requirements of the medical industry. The following are some common medical wiring harness standards: 1. IEC 60601-1: This standard is an international standard for the safety of medical electrical equipment. It specifies the general safety requirements for medical equipment, including electrical safety, mechanical safety and insulation safety of wiring harness. 2. IEC 60601-1-2: This standard is an international standard for the electromagnetic compatibility of medical electrical equipment. It specifies the anti-interference capability of medical equipment and its wiring harness in the electromagnetic environment to ensure its normal operation without causing interference to other equipment and the environment. 3. ISO 13485: This standard is the international standard for the quality management system of medical devices. It specifies the quality management system requirements to be followed by medical device manufacturers, including requirements for wiring harness design, manufacturing, testing and verification. 4.AAMI/ANSI ES60601-1: This standard is the standard for the safety of medical electrical equipment in the United States. It is similar to IEC 60601 -1 and specifies requirements for the safety of medical devices and their wiring harnesses. 5. UL 60601-1: This standard is the standard for the safety of medical electrical equipment in the United States, developed by the United States Safety Laboratory (Under writers Laboratories). It is similar to IEC 60601 -1 and specifies requirements for the safety of medical devices and their wiring harnesses. 6. FDA 21 CFR Part 820: This standard is the requirements of the US Food and Drug Administration (FDA) for the quality management of medical devices. It specifies the quality management requirements that medical device manufacturers should follow, including the design, manufacture, verification and documentation of wiring harnesses. In addition to the above international and industry standards, different countries and regions may have their own standards and specifications for medical wiring harnesses. For example, China's national standards GB9706.1-2007 Medical Electrical Equipment Part 1: General Requirements and GB9706.15-2008 Medical Electrical Equipment Part 2-15: Safety Requirements, etc. These standards and specifications are designed to ensure that the design, manufacture and use of medical wiring harnesses meet the special requirements of medical equipment, including safety, reliability, interference resistance and quality management requirements. Medical harness manufacturers and medical device manufacturers should follow these standards to design, test, and verify harnesses to ensure that the safety and performance of medical devices meet regulatory and industry requirements.

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