Medical Device Safety Testing

Electro-Medical device testing, certification, and evaluation for compliance to Product Safety requirements.

End-to-end testing, certification, and evaluation helping you ensure the conformity of your Medical Electrical Equipment to product safety & essential performance requirements for global product approvals.

An active medical device is considered as any medical device which relies on a source of electrical energy or any source of power other than that directly generated by the human body or gravity in order to function.

Product Safety requirements for electrical active medical devices are documented and internationally harmonized under the IEC 60601-xx standard family which is the base for the approval procedure of medical electrical equipment in most regulatory frameworks all over the world.

Eurofins E&E provides the full range of product safety testing per the 60601-1 series of standards including collateral (Part 1) and particular (Part 2) standards. In addition we offer complete testing for active implantable devices (ISO 14708).

The MET NRTL mark indicates compliance to required standards for workplace safety which includes locations such as hospitals, clinics, therapy centers, and similar facilities. The NRTL mark is required under federal law for products used in workplaces in all 50 states.

As a National Certification Body (NCB) and CB Testing Laboratory (CBTL) in the IECEE CB Scheme, Eurofins E&E can also perform testing & certification in accordance with all editions of 60601-1 safety standards for medical electrical equipment in participating member countries.

Why Eurofins E&E North America?

The MET NRTL mark is the first ever officially recognized by OSHA for workplace safety. We provide the full range of product safety testing per the 60601-1 series of standards including collateral (Part 1) and particular (Part 2) standards. In addition we offer complete testing for active implantable devices (ISO 14708).

From prototype evaluations and pre-compliance testing to full-compliance testing and certification, our state-of-the-art 3-, 5-, and 10-meter EMC chambers are equipped to evaluate your medical device to requirements within the EMC Directive, including IEC 60601-1-2 and IEC 60601-2-x particular standards.

MET provides testing and technical reports that can be used to support a manufacturer's Declaration of Conformity (DoC) for CE marking. Eurofins Medical Device Testing is a Notified Body authorized to issue Type Certificates for active and nonactive medical devices in accordance with Directive 93/42/EEC. Eurofins Medical Device Testing also works with product designers and manufacturers in order to certify products under several annexes of the MDD.

Our Medical Safety Testing & Certification Capabilities

• NRTL (Nationally Recognized Testing Laboratory) recognized by the Occupational Safety and Health Administration of US (OSHA) for medical equipment
• IEC/EN 60601-1 3rd Edition
• UL 60601-1
• AAMI ES60601-1
• CSA C22.2 No. 601.1
• Electrical wheelchairs to ANSI/RESNA/FDA/EN requirements including RESNA WC-1:2009
• FDA devise submissions for FDA clearance
• Complete testing for active implantable devices (ISO 14708)
• National Certification Body (NCB) & Certification Body Testing Laboratory (CBTL) testing & certification for Medical Electrical products
• Medical Device Battery Safety Testing

Your Global Testing Partner for Notified Body Services and Global Approvals

With 16 laboratories in North America, Europe and Asia Pacific, we offer regulatory compliance expertise and experienced GMP/GLP/ISO 17025 testing to ensure rapid turnaround times with the highest level of service, and most advanced technologies for your analytical chemical, microbiological, biocompatibility, electrical, mechanical and package testing needs.

Our international presence ensures a unique global breadth of harmonized capabilities to solve all of your testing challenges and guide you through the complex regulatory landscape to help you develop the optimal strategy for your medical device testing needs.

Notified Body Services:

• Type Examination (Annex III): – EC certificate showing conformity of the Medical Device examined (type) with the essential requirements established in the directive.
• EC Verification (Annex IV): – EC certificate that guarantees and declares that the production batch(statistical verification) or each product (individual verification) conforms to the type certified and to the applicable requirements of the directive.
• EC Declaration of Conformity: – Guarantee of quality of the manufacturing process or of the product (annexes V-VI), the certificate that guarantees and declares that the quality system, with regard to sterility, is applied and complies with the requirements of the directive.

Other Related Services:

• Chemical / Physical Analysis
• Microbiology & Sterility
• Packaging & Seal Integrity
• Biocompatibility
• Combination Products

What is Medical Device Safety Testing?

Medical device safety testing involves evaluating a medical device’s compliance to IEC 60601-1 3rd Edition, the internationally harmonized safety standard used for all electronic medical devices. There may be additional requirements for full safety compliance, such as those set forth by the FDA and other regulatory bodies within various countries, but the basic requirements for medical device safety testing will be found in the IEC 60601-1 3rd Edition Document. According to the 60601-1 3rd Edition, medical devices will be evaluated to protected against:

• Electrical Shocks
• Mechanical Hazards
• Unwanted and Excessive Radiation
• Ignition Hazards
• Abnormal Operation and Faults
• Constructional Defects

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