What is EN ISO 14386-2:2021?

EN ISO 14386-2:2021 is a technical standard that defines the requirements for the development and implementation of medical devices utilizing lasers. This standard focuses on the safety aspects of medical laser equipment and provides guidelines for manufacturers, healthcare professionals, and regulatory bodies.

The Scope and Purpose of EN ISO 14386-2:2021

The scope of EN ISO 14386-2:2021 includes laser-based medical devices used in various fields such as surgery, dermatology, ophthalmology, and dentistry. Its purpose is to ensure the safety of patients, operators, and others in the vicinity of the equipment by setting specific safety and performance requirements.

Main Requirements of EN ISO 14386-2:2021

The main requirements outlined in EN ISO 14386-2:2021 include the classification of laser products, risk assessment, marking and labeling, and the provision of user information. It emphasizes the need for hazard identification, risk analysis, and risk mitigation measures throughout the design, manufacturing, installation, and operation of medical laser devices.

Adherence and Compliance

Manufacturers of medical laser equipment must comply with the requirements set forth in EN ISO 14386-2:2021 to ensure their products meet the necessary safety standards. Compliance demonstrates an understanding of the potential risks associated with laser use in medical applications and the commitment to mitigating those risks for the well-being of patients and healthcare providers.