BS EN IEC 61326-2-6:2021

Comprehensive Healthcare Technology Standard

BS EN IEC 61326-2-6:2021 is a critical standard for ensuring the safety and electromagnetic compatibility (EMC) of electrical equipment used in medical environments. This standard, identical to IEC 61326-2-6:2020, provides essential requirements and test methods to protect patients, staff, and sensitive medical devices from potential electromagnetic disturbances.

Key Specifications

- Applies to electrical equipment and systems intended for use in the medical environment- Covers requirements for immunity to electromagnetic disturbances and emissions of electromagnetic disturbances- Specifies test methods and acceptance criteria to demonstrate compliance- Harmonized standard under the Medical Devices Directive 93/42/EEC and In Vitro Diagnostic Medical Devices Directive 98/79/EC

Benefits of Compliance

- Ensures the safety and reliability of medical equipment in the presence of electromagnetic disturbances- Protects patients and staff from potential health risks associated with electromagnetic interference- Enables medical facilities to meet regulatory requirements for medical device safety and EMC- Supports the development of innovative medical technologies that can operate effectively in complex electromagnetic environments

Comprehensive Test Requirements

BS EN IEC 61326-2-6:2021 outlines a comprehensive set of test requirements to verify the EMC performance of medical equipment, including:- Immunity tests for: - Electrostatic discharge - Radiated radio-frequency electromagnetic fields - Electrical fast transient/burst - Surge - Conducted disturbances induced by radio-frequency fields - Power frequency magnetic fields- Emission tests for: - Conducted and radiated emissions - Harmonic current emissions - Voltage fluctuations and flickerThe standard also provides guidance on test setups, measurement procedures, and acceptance criteria to ensure consistent and reliable evaluation of medical equipment.

Compliance and Certification

Demonstrating compliance with BS EN IEC 61326-2-6:2021 is essential for medical device manufacturers and healthcare providers to ensure the safety and performance of their equipment. Certification to this standard can be obtained through accredited testing laboratories, providing a recognized mark of quality and compliance.By adhering to the requirements of BS EN IEC 61326-2-6:2021, medical equipment manufacturers can develop products that are safe, reliable, and capable of operating effectively in the complex electromagnetic environments of modern healthcare facilities.