Medical Laboratory Equipment: IEC 61010 and Electrical Safety Requirements

What is IEC 61010?

The IEC 61010 series sets comprehensive safety requirements for electrical equipment used in measurement, control and laboratory environments. When your product is designed for medical diagnostics, clinical analysis or laboratory-based use, aligning with IEC 61010 ensures that users and patients are protected from electrical shock, fire, mechanical and other energy-related hazards. At Intertek, we help medical-device and diagnostic-instrument manufacturers navigate these requirements and achieve compliance efficiently.

Why it matters in the medical-lab environment

In medical and diagnostic laboratories, equipment plays a critical role in patient care, data integrity and safety. Overlooking electrical or mechanical hazards can put staff, patients or samples at risk. IEC 61010 supports regulatory readiness (for example in jurisdictions where safety of laboratory apparatus is monitored), ensures design robustness and supports market access. With the rapid evolution of diagnostic instruments—connected systems, robotics, automation—the need to prove safe operation and maintain electrical/EMC integrity is higher than ever.

Scope of IEC 61010 for medical/lab equipment

While IEC 61010 covers measurement, control and laboratory use generally, in a medical/diagnostic-lab context typical equipment includes:

• Clinical chemistry analyzers, hematology instruments, immunoassay systems
• In vitro-diagnostic (IVD) analyzers and ancillary lab equipment
• Automation systems, sample-handling robots, point-of-care laboratory devices
• Smaller benchtop instruments for measurement or control in a laboratory
• Safety-relevant accessories and embedded modules in diagnostic systems
  The standard addresses safety features, protective measures and performance requirements for such devices, and covers hazards such as electrical shock, fire, mechanical hazards and hazards related to energy sources.

Intertek’s services for medical/lab IEC 61010 compliance

• Risk-based assessment aligned with Clause 17 of IEC 61010-1 Third Edition: risk analysis, evaluation and reduction.
• Safety testing: verification of protective earth, insulation, leakage current, temperature rise, overvoltage categories, mechanical safety, etc.
• Certification: we offer the regulatory mark/labeling (e.g., ETL mark) and globally recognised compliance pathways.
• Field Labeling / Limited Product Certification: for custom laboratory systems or small-series equipment we provide flexible solutions.
• Global market access support: tailored to medical diagnostics, we support jurisdictional requirements (e.g., hyped IVD, lab-automation, robotics) and interoperability.
• Ongoing support: we help with revisions (Edition 3, Amendment 1), updates, documentation maintenance.

Why choose Intertek for medical/lab equipment

With deep experience in medical devices and laboratory systems, Intertek brings a unique combination of regulatory-expertise and test-lab infrastructure. Our global network can support multi-site compliance, help you reach markets efficiently, and reduce time-to-market. We’ve helped manufacturing teams design for safety, integrate hazard-mitigation early, and ensure that lab-based equipment meets electrical/controls safety standards with minimal rework.

If you are manufacturing or designing medical or diagnostic laboratory equipment subject to IEC 61010, contact our Intertek specialists today. We will guide you through risk assessment, testing, certification and market-access strategy. Let’s make your next-generation lab system safe, compliant and ready for markets.

IEC 61010 Series — 2025 and Beyond | Fact Sheet

Stay ahead of evolving global safety requirements for laboratory, measurement, and control equipment. This fact sheet distills the latest developments across the IEC 61010 series, including changes ahead for Amendment 2 of IEC 61010-1

IEC 61010 Series: Master the Challenge & Keep Up with the Changes | White Paper

IEC 61010 is a widely accepted electrical safety standard for laboratory, process control, and test & measurement equipment. This paper delivers an overview of the latest developments, new and revised requirements, the status of Edition 3 and Amendment 1 in major markets, and much more.