What is EN 60601-1:2015?

EN 60601-1:2015 is a technical standard that establishes the general requirements for the safety and essential performance of medical electrical equipment. It is part of a series of standards that outline the safety requirements for different types of medical devices. This standard applies to a wide range of medical equipment including diagnostic, therapeutic, and monitoring devices.

Scope of EN 60601-1:2015

The scope of EN 60601-1:2015 covers both the safety and essential performance of medical electrical equipment. Safety aspects include protection against electrical hazards, mechanical risks, and potential hazards originating from software used in the equipment. Essential performance refers to the functions necessary for the device to achieve its intended purpose.

Key Concepts and Requirements

EN 60601-1:2015 introduces several key concepts and requirements to ensure the safety and essential performance of medical electrical equipment. Some of these include:

Risk management: The standard emphasizes the need for manufacturers to conduct thorough risk assessments throughout the lifecycle of the equipment.

Usability: Medical devices should be designed with the user in mind, ensuring they are user-friendly and intuitive to operate.

Electromagnetic compatibility: Equipment should be designed to minimize electromagnetic interference that could affect its performance or pose risks to patients.

Environmental considerations: The standard addresses the impact of the environment on the equipment's safety and performance, including temperature, humidity, and mechanical stresses.

Compliance and Certification

Manufacturers must ensure their medical electrical equipment complies with the requirements of EN 60601-1:2015 to ensure patient safety and product quality. Compliance is typically demonstrated through certification by a recognized conformity assessment body. By meeting the standard's requirements, manufacturers can demonstrate that their products meet the necessary safety and performance criteria.