What is EN 60601-2-18:2009?

Introduction

EN 60601-2-18:2009 is an international standard that specifically addresses the safety and performance requirements for medical electrical equipment used in medical practices, such as diagnostic ultrasound devices. The standard provides guidelines to ensure that these devices meet specific safety criteria and perform effectively and reliably.

Scope and Objectives

This section discusses the scope and objectives of EN 60601-2-18:2009. The standard applies to all parts of medical electrical equipment (MEE) used for diagnostic and therapeutic purposes, specifically within the frequency range of human hearing (approximately 20 Hz – 20 kHz). The primary objective is to establish requirements to minimize risks associated with the use of MEE.

Risk Assessment and Test Requirements

In order to comply with EN 60601-2-18:2009, manufacturers need to perform a comprehensive risk assessment during the design and development stages of their medical electrical equipment. This involves identifying potential hazards and estimating associated risks. Once the risks are identified, appropriate measures can be implemented to eliminate or reduce those risks to an acceptable level.

The standard also specifies test requirements to assess the safety of the electrical, thermal, mechanical, and functional aspects of the MEE. These tests are conducted to verify compliance and ensure that the device functions safely under normal and abnormal conditions.

Compliance and Certification

To demonstrate compliance with EN 60601-2-18:2009, medical electrical equipment manufacturers must conduct a series of tests according to the specified requirements. Upon successful completion of these tests, they can obtain certification from accredited bodies. It is important for manufacturers to periodically review and update their products to ensure ongoing compliance with the standard.

Compliance with EN 60601-2-18:2009 is crucial not only for meeting regulatory requirements but also for ensuring patient and operator safety. It helps establish confidence in the quality and reliability of medical electrical equipment, providing healthcare professionals and patients with peace of mind.

Overall, EN 60601-2-18:2009 sets forth essential safety guidelines and performance requirements for medical electrical equipment used in diagnostic practices. Compliance with this standard is vital to ensure patient safety and to maintain the integrity of the medical device industry.