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Medical Device

Testing For Life

Through rigorous evaluation and trusted certification, we help bring life-saving technologies to market faster, safer and stronger. Backed by our FDA ASCA- accredited labs and a global network of specialists, we empower you to deliver care with certainty. Ever test we run is a step toward better care.

Raising the Standard for Medical Device Safety

Our expert teams support manufacturers through rigorous evaluations of electrical, mechanical, and environmental safety to ensure devices meet global regulatory expectations. With FDA ASCA-accredited labs and decades of medical testing expertise, Eurofins Electrical & Electronics helps bring your innovations to market with speed, confidence, and integrity. Every test we perform safeguards not just compliance, but medical professionals and their patients.

The MET Mark Advantage

Compliance Made Easy With Credibility & Confidence.

Elevate your brand to the global market with the MET Mark.

What is MET Mark?

The MET Mark is a globally-trusted symbol signifying your products meet rigorous safety standards. Recognized by retailers, distributors, and regulatory authorities in 53 countries, the MET Mark strengthens consumer confidence and streamlines market entry.

Benefits of the MET Mark for Manufacturers

Enhances product credibility and market recognition.
Facilitates access to global markets.
Reduces the need for additional testing and certification in multiple markets.

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Products Covered Under the Standard

Diagnostic equipment (e.g., X-ray machines, CT scanners, MRIs)

Patient monitoring systems (e.g., heart rate monitors, blood pressure monitors)

Life-support equipment (e.g., ventilators, defibrillators)

Surgical instruments (e.g., medical lasers, electrosurgical units)

Infusion pumps

Dialysis machines

Oxygen concentrators

Blood analyzers

DNA sequencers

ECG machines

Ultrasound machines

Mammography systems

PET scanners

Medical Accessories

Surgical instruments

Medical lights (e.g., examination lights)

Products Covered Under the Standard

Medical Devices

Diagnostic equipment (e.g., X-ray machines, CT scanners, MRIs)

Patient monitoring systems (e.g., heart rate monitors, blood pressure monitors)

Life-support equipment (e.g., ventilators, defibrillators)

Surgical instruments (e.g., medical lasers, electrosurgical units)

Infusion pumps

Dialysis machines

Oxygen concentrators

Medical Testing Devices

Blood analyzers

DNA sequencers

ECG machines

Ultrasound machines

Diagnostic-Imaging-Systems

Mammography systems

PET scanners

Medical Accessories

Surgical instruments

Medical lights (e.g., examination lights)

Brand Testimonials

“The best Webflow Templates”

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Sophia Moore

CEO at Webflow Agency

“The best Webflow Templates”

Sophia Moore

CEO at Webflow Agency

“The best Webflow Templates”

Sophia Moore

CEO at Webflow Agency

“The best Webflow Templates”

Sophia Moore

CEO at Webflow Agency

IEC 60601-1 ensures medical electrical equipment meets strict safety standards, protecting users from electrical, thermal, and mechanical hazards in healthcare settings.

IEC 60601-1 applies to a wide range of medical devices, including patient monitors, ventilators, imaging equipment, and other devices used in clinical environments.

It sets standards for insulation, spacing, and leakage current limits, ensuring devices operate safely around patients and staff.

IEC 60601-1 limits surface temperatures, mandates adequate ventilation, and specifies thermal controls to prevent overheating, safeguarding both patients and healthcare providers.

Medical devices must be designed to prevent risks from moving parts, sharp edges, and mechanical impact, ensuring durability and safety in clinical use.

IEC 60601-1 categorizes user roles (e.g., clinicians, technicians) and provides safeguards tailored to the expertise level of each, ensuring safe use in varied clinical scenarios.

Yes, devices must withstand environmental stresses like temperature fluctuations, humidity, and mechanical vibrations to ensure reliability across settings.

Yes, EMC testing ensures that medical devices do not interfere with other equipment and are immune to interference themselves.

IEC 60601-1 requires detailed user manuals, maintenance instructions, safety labels, and certification marks for safe operation and compliance verification.

IEC 60601-1 aligns closely with the IEC 60601-1 standard, making it applicable internationally and compliant with U.S. regulations through additional requirements.

With extensive experience and dedicated advisory services, Eurofins Electrical & Electronics supports manufacturers from initial design to certification, ensuring full compliance and reliability.

IEC 60601-1 requires manufacturers to identify and mitigate risks, focusing on hazard-based safety engineering to anticipate and prevent possible hazards.

IEC 60601-1: Medical Electrical Equipment Testing & Certification

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Medical Device Testing For Life

Medical Device

Testing For Life

Raising the Standard for Medical Device Safety

Why Choose Eurofins Electrical & Electronics?

10,000+

60+ Years

Global Recognition

EPA-Recognized

Achieve Faster Certification with Eurofins Electrical & Electronics

Get a Gap Analysis & Recommendations

Receive a Customized Testing Plan

Stay Informed With Real-Time Project Tracking

Access Global Markets

The MET Mark Advantage

Benefits of the MET Mark for Manufacturers

Enhances product credibility and market recognition.

Facilitates access to global markets.

Reduces the need for additional testing and certification in multiple markets.

Accelerate Global Launches with GMA

Power Your Products With the ENERGY STAR® Certification

Offer Eco-friendly Products

Gain a Competitive Edge

Products Covered Under the Standard

Products Covered Under the Standard

Medical Devices

Medical Testing Devices

Diagnostic-Imaging-Systems

Brand Testimonials

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FAQ

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