Safety Solutions for Medical Devices

Safety testing for medical devices is a comprehensive evaluation process to ensure devices are safe, reliable, and effective for use. It encompasses assessments of electrical safety (e.g., protection against shocks and overheating), mechanical integrity (e.g., durability under stress), and biocompatibility of materials, ensuring they are non-toxic and safe for contact with human tissue. Testing also includes environmental stress tests to confirm performance under varying conditions, while electromagnetic compatibility (EMC) tests ensure devices operate without interference. These tests adhere to global standards like, IEC 60601, helping manufacturers meet regulatory requirements and protect patients and users from potential risks.

We know a faster launch means more immediate access to life-saving technology and at Intertek, we’re committed to clearing a path to market for your latest innovation. With Intertek as your partner, you can navigate the mandatory requirements for electrical safety and deliver your product into the hands of healthcare professionals, patients, and caregivers faster than anyone else in the industry. That means shorter time to revenue generation and increased profitability for your organization.

IEC 60601: Product Safety Standards for Medical Devices

We offer end-to-end solutions from product development and risk management file review/documentation, to comprehensive testing to IEC 60601 series of standards.

IEC 60601-1-2: Medical Device EMC Testing

IEC 60601-1-2 Electromagnetic Compatibility (EMC) Testing for Medical Devices including IEC 60601-1-2 4th Edition Amendment 1.

Home Healthcare Equipment Testing and Certification

Intertek offers comprehensive Testing and Certification solutions for Home Healthcare Equipment to all applicable standards including IEC 60601-1-11.

Medical Imaging Equipment Testing

Intertek offers Medical Imaging Equipment Testing and Certification solutions ensuring your medical imaging equipment meets all applicable safety requirements

Biocompatibility Testing and Evaluation

Intertek is an industry leader in Biocompatibility Testing and Evaluation for medical devices, delivering comprehensive solutions aligned with ISO standards to ensure safety and compliance.

ISO 18562 and VOC Testing for Medical Devices

Intertek is committed to providing expert ISO 18562 and VOC Testing and Evaluation solutions of breathing gas pathways in medical devices with comprehensive expertise and solutions.

IEC 61010: Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use

IEC 61010 is the standard for testing Medical Laboratory Equipment. Ensure your products remain in compliance with the latest revision of IEC 61010 with Intertek

Implantable Medical Devices Testing Solutions

Intertek can help Implantable Medical Devices such as Cochlear Implants, monitoring devices, pacemakers, etc comply to safety, EMC and product-specific standards

Ventilator Production & Testing

Intertek can provide immediate Ventilator Testing assistance for manufacturers along with regulatory requirement guidance for safety, performance, labeling and more

SPE-3000: Medical Field Evaluations

For medical products entering the Canadian market, SPE-3000 serves as the model code for the field evaluation of medical electrical equipment (MEE) and medical electrical systems (MES), specifically pertaining to safety from electric shock, fire and mechanical hazards.