Electrical Safety Testing for Medical Devices

Intertek offers electrical safety testing of medical equipment in as little as 15 days. You can depend on our experience and expertise to help you reach your target markets quickly and cost effectively.

Before your medical device can be sold domestically or globally, it must demonstrate compliance with electrical safety standards. This mandatory process helps to ensure that your medical device poses no fire, shock, or overall safety hazards to the patient or end user that comes in contact with your product.

Medical Device Requirements for North America

Before your medical device can be sold within North America, it must demonstrate compliance with such safety standards as IEC 60601-1 3rd Edition. Once your product has been found to be in compliance with the applicable safety requirements, the ETL Listed Mark will be applied to your product. The ETL Listed Mark indicates that your product has been independently tested by an OSHA-recognized Nationally Recognized Testing Laboratory (NRTL), found to be compliant with applicable safety standards, and meets the minimal requirements for sale or distribution within North America.

Requirements for the European Union and Beyond

Regardless of your target market, Intertek can help you demonstrate your product’s compliance to all regional safety requirements:

CB Scheme – As a National Certification Body (NCB) and CB Testing Laboratory (CBTL), Intertek can guide you through the entire process and help you meet the requirements of the 40 countries that participate in the CB Scheme for medical devices.

CCC Mark – Manufacturers in 132 product categories, including medical devices, must obtain the China Compulsory Certification (CCC) mark before exporting to or selling in the Chinese market.

S Mark – The S Mark provides evidence to authorities and your customers that Intertek has independently tested and certified your product’s compliance to applicable European safety requirements.

CE Mark for Medical Devices – Before your products can be placed on the European market, they must meet the requirements of the relevant product directives (joint rules that have been put in place to simplify trade to and between the member countries of the European Union). All directives dealing with safety require products to be CE marked before they can be marketed within the EU. As a Notified Body for CE Marking, Intertek can test your product to the following Directives:

• Medical Device Directive (MDD) - In order to market your medical device within the member states of the European Union, your product must comply with the essential compliance requirements of the MDD.
• In-Vitro Diagnostic Directive (IVDD) - The IVDD addresses the essential requirements that an in-vitro diagnostic device (and its accessories) must meet before being marketed within the European Union.

Contact us to see how Intertek can help your organization with Electrical Safety Testing for Medical Devices.