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Medical Device Performance and Safety Testing

UL Solutions provides performance, safety testing, certification and regulatory compliance services for medical and healthcare devices.

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The growing complexity of medical devices and laboratory equipment requires more advanced testing and certification to evaluate safety, performance and compliance with regulatory requirements. This is critical for safe and effective patient care.

Our performance and safety testing offerings are designed to address a variety of medical device and laboratory equipment certification needs. Regulators update their requirements frequently while the healthcare sector strives to adapt to connected and evolving technologies.

Our deep technical expertise helps you demonstrate the safety of your products and stay up to date with evolving standards, regulations and directives. 

Find out more in our brochure.

Watch now: Solutions for the healthcare and life sciences industry

Dedicated to healthcare industry innovation, we leverage decades of technical, regulatory and clinical expertise to help you manage regulatory challenges and bring safer products to market faster.

We can help you with:

Product performance and safety testing to standards such as:

  • IEC/AAMI 60601, Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
  • IEC 60601-1-2, Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests
  • IEC 61010, Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use
  • IEC 61326-1, Electrical Equipment for Measurement, Control and Laboratory Use – EMC Requirements – Part 1: General Requirements
  • IEC 61326-2-6, Electrical Equipment for Measurement, Control and Laboratory Use – EMC requirements – Part 2-6: Particular Requirements – In Vitro Diagnostic (IVD) Medical Equipment
  • UL 1069, the Standard for Hospital Signaling and Nurse Call Equipment
  • UL 2560, the Standard for Emergency Call Systems for Assisted Living and Independent Living Facilities
  • UL 1431, the Standard for Personal Hygiene and Health Care Appliances
  • IEC 62304, Medical Device Software – Software Life Cycle Processes
  • IEC 62366-1, Medical Devices – Part 1: Application of Usability Engineering to Medical Devices
  • ANSI/CAN/UL 2900-1, the Standard for Software Cybersecurity for Network-Connectable Products, Part 1: General Requirements
  • ANSI/CAN/UL 2900-2-1, the Standard for Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems

Customized validation and verification testing: 

  • AAMI EC12, Disposable ECG Electrodes 
  • ASTM E1112, Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature 
  • Algorithm reproducibility process (for medical artificial intelligence) 
  • UL Marketing Claim Verification

Medical regulatory compliance services:

Other healthcare industry testing services:

Why partner with UL Solutions?  

We are dedicated to healthcare industry innovation, leveraging decades of technical, regulatory and clinical expertise to help you manage regulatory challenges and bring safer products to market faster.

Our testing and compliance engineers work closely with standards committees to stay up to date on all the new amendments and upcoming changes. These committees include the American National Standards Institute (ANSI), the Association for the Advancement of Medical Instrumentation (AAMI) and the International Electrotechnical Commission (IEC). UL Solutions has several U.S. Food and Drug Administration (FDA) Accreditation Scheme for Conformity Assessment (ASCA)-accredited testing laboratories including UL LLC in the U.S., Japan and Italy.

We provide a single source for your needs, helping you save time and money. Our comprehensive suite of services includes end-product testing, certification, validation (electromagnetic compatibility (EMC), wireless, safety, interoperability, cybersecurity, biocompatibility) and Global Market Access.

To learn more, contact us.

Downloads
Medical

Medical Testing Services Overview Brochure (English)

7.72 MB
Transitioning

Transitioning to IEC 60601-1 amendment 2 Infosheet (English)

459.6 KB
Make

Make the Change to UL Solutions infosheet

463.98 KB
UL

UL Solutions non-clinical services infosheet

521.82 KB
Healthcare

Healthcare Cybersecurity Solutions (English Quick Sheet)

527.79 KB
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