IEC 60601 Medical Device Testing by MDS Finland

MDS Finland offers specialized testing services to ensure compliance with the IEC 60601 series, a comprehensive set of standards crucial for the safety and performance of medical electrical equipment. Our focus on adhering to these standards demonstrates our commitment to the highest levels of safety and quality in medical device development.

IEC 60601 Testing Services

Foundational Standard IEC 60601-1 Compliance

The IEC 60601-1 standard is the cornerstone of the series, setting the general requirements for basic safety and essential performance. We provide thorough testing to ensure your device meets these fundamental requirements.

Particular Standards Specific to Device Types

The IEC 60601 series branches into specific standards for various medical devices like high-frequency surgical equipment, endoscopic equipment, and infant incubators. Our testing services cover these particular standards, tailored to the specific type of medical electrical equipment you develop.

Collateral Standards for Broad-Based Requirements

We address broad-based requirements that may apply to your device through collateral standards testing. This includes Electromagnetic Compatibility (EMC), Usability Engineering Analysis, and adaptation to the Home Use Environment.

EMC Testing

Compliance with IEC 60601-1-2 for EMC is crucial to ensure that your device operates correctly in its intended electromagnetic environment. We conduct comprehensive EMC tests to prevent unacceptable electromagnetic disturbances.

Ensuring Device Usability and Safety

Our testing services extend to the collateral standards that ensure your device is userfriendly, safe, and suitable for the intended environment, whether in clinical settings or for home use.

WHY CHOOSE MDS FINLAND FOR IEC 60601 COMPLIANCE TESTING?

Expertise in Medical Device Standards

Our team is highly experienced in the nuances of the IEC 60601 series, offering you precise and reliable testing services.

Customized Testing Solutions

We provide testing services tailored to the specific requirements of your medical electrical equipment, ensuring comprehensive compliance.

Commitment to Quality and Safety

Our adherence to these international standards underlines our dedication to ensuring the highest quality and safety of medical devices.

STREAMLINING YOUR PATH TO COMPLIANCE

At MDS Finland, our goal is to facilitate your journey towards achieving compliance with the IEC 60601 standards. By entrusting us with the testing of your medical electrical equipment, you are assured of thorough and efficient services that not only comply with regulatory standards but also uphold the highest safety and performance levels.