What is ISO/IEC 80601-2-61: 2017 ?

ISO/IEC 80601-2-61: 2017 is a crucial standard for the healthcare industry. It is a technical specification that outlines the requirements and tests for the basic safety and essential performance of medical electrical equipment. Developed by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), the standard is designed to ensure that medical devices meet the necessary safety and performance criteria.

The key requirements of ISO/IEC 80601-2-61: 2017 are designed to ensure the safety and reliability of medical electrical equipment. These requirements include:

Essential safety requirements: The standard specifies the essential safety requirements that medical electrical equipment must meet to ensure patient safety. These requirements include requirements for electrical safety, mechanical safety, and environmental safety.

Essential performance requirements: The standard specifies the essential performance requirements that medical electrical equipment must meet to ensure reliable operation. These requirements include requirements for electrical performance, mechanical performance, and environmental performance.

Test requirements: The standard specifies the tests that medical electrical equipment must undergo to ensure compliance with the requirements. These tests include both functional tests and non-functional tests, such as electrical and mechanical tests.

By complying with ISO/IEC 80601-2-61: 2017, manufacturers can demonstrate that their medical electrical equipment has undergone thorough testing and assessment, meeting the necessary quality standards. Additionally, this standard provides guidance for healthcare professionals on the proper use and maintenance of these devices, contributing to patient safety and well-being.

In conclusion, ISO/IEC 80601-2-61: 2017 is an essential standard for the healthcare industry. It ensures the safety and reliability of medical electrical equipment, while also providing guidance for healthcare professionals on the proper use and maintenance of these devices. Compliance with this standard is mandatory for manufacturers, while non-compliance may have serious consequences for patients and healthcare professionals.