Medical Industry Standards for Rotary Electrical Connectors
Posted: Thu Feb 13, 2025 7:13 am
The main medical industry standards that rotary electrical connectors must comply with when designing medical devices include:
IEC 60601 - General requirements for the safety and performance of medical electrical equipment developed by the International Electrotechnical Commission (IEC). This standard covers all aspects of medical electrical equipment and medical electrical systems, including rotary electrical connectors.
ISO 13485 - Quality management system standard published by the International Organization for Standardization (ISO) specifically for the medical industry. It specifies the requirements for a quality management system to be met by organizations involved in the design, manufacture and sale of medical devices.
FDA 21 CFR Part 11 - A regulation of the US Food and Drug Administration (FDA) that includes specifications for electronic records and electronic signatures. If rotary electrical connectors are used to oman number data record or transmit medical data, they must comply with these requirements.
EN 60601 - A European standard similar to IEC 60601, it is a harmonized standard for the safety and performance of medical electrical equipment.
UL 2601 - The American safety standard for general safety requirements for medical devices developed by Underwriters Laboratories (UL).
CE Marking Requirements - Medical devices placed on the EU market must meet the CE marking requirements, which typically include compliance with relevant health, safety, and environmental requirements.
Electromagnetic Compatibility (EMC) Standards - Such as IEC 60601-1-2, establish requirements for electromagnetic compatibility in medical electrical devices and medical power supply systems.
IEC 60601 - General requirements for the safety and performance of medical electrical equipment developed by the International Electrotechnical Commission (IEC). This standard covers all aspects of medical electrical equipment and medical electrical systems, including rotary electrical connectors.
ISO 13485 - Quality management system standard published by the International Organization for Standardization (ISO) specifically for the medical industry. It specifies the requirements for a quality management system to be met by organizations involved in the design, manufacture and sale of medical devices.
FDA 21 CFR Part 11 - A regulation of the US Food and Drug Administration (FDA) that includes specifications for electronic records and electronic signatures. If rotary electrical connectors are used to oman number data record or transmit medical data, they must comply with these requirements.
EN 60601 - A European standard similar to IEC 60601, it is a harmonized standard for the safety and performance of medical electrical equipment.
UL 2601 - The American safety standard for general safety requirements for medical devices developed by Underwriters Laboratories (UL).
CE Marking Requirements - Medical devices placed on the EU market must meet the CE marking requirements, which typically include compliance with relevant health, safety, and environmental requirements.
Electromagnetic Compatibility (EMC) Standards - Such as IEC 60601-1-2, establish requirements for electromagnetic compatibility in medical electrical devices and medical power supply systems.