Within the scope of medical device security testing, testing, certification and evaluation services of medical devices are provided for compliance with safety requirements.
Medical device safety testing involves evaluating a medical device's compliance with 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 specified by the FDA and other regulatory agencies in various countries, but the basic requirements for medical device safety testing can be found in the 60601rd Edition Document IEC 1-3. According to 60601-1 3rd Edition, medical devices will be considered to be protected against:
EUROLABprovides end-to-end testing, certification and evaluation services that help you ensure that your medical electrical equipment complies with essential performance requirements for product safety and global product approvals.
An active medical device is considered any medical device that relies on a source of electrical energy or any power source other than that produced directly by the human body or gravity to function.
Product Safety requirements for electrical medical devices are documented and internationally harmonized under the IEC 60601-xx family of standards, which form the basis of the approval procedure for medical electrical equipment in most legal frameworks around the world.
EUROLABprovides all product safety testing for the 1-2 series of standards, including collateral (Part 60601) and specific (Part 1) standards. In addition, we offer complete testing for active implantable devices (ISO 14708).
EUROLABThe NRTL mark indicates compliance with the standards required for workplace safety, such as hospitals, clinics, therapy centers and similar facilities.
As a National Certification Body (NCB) and CB Testing Laboratory (CBTL) in the IECEE CB Program EUROLABcan also perform testing and certification in accordance with all versions of the 60601-1 safety standards for medical electrical equipment in participating member countries.
EUROLAB The NRTL mark is the first mark officially recognized by OSHA for workplace safety. We offer the full range of product safety testing for the 1-2 series of standards, including collateral (Part 60601) and specific (Part 1) standards. In addition, we offer complete testing for active implantable devices (ISO 14708).
From prototype evaluations and pre-conformity testing to full conformity testing and certification, our state-of-the-art 3-, 5, and 10-meter EMC chambers are equipped to evaluate your medical device according to the requirements within the EMC Directive. IEC 60601-1-2 and IEC 60601-2-x contain specific standards.
EUROLABprovides tests and technical reports that can be used to support the manufacturer's Declaration of Conformity (DoC) for CE marking. EUROLAB Medical Device Testing is a notified body authorized to issue Type Certificates for active and inactive medical devices in accordance with Directive 93/42/EEC. EUROLAB Medical Device Testing also works with product designers and manufacturers to certify products under the various annexes of the MDD.
• Type Examination (Annex III): - EC certificate showing the conformity of the examined Medical Device (type) with the basic requirements specified in the directive.
• EC Verification (Annex IV): - EC certificate guaranteeing and declaring that the batch of production (statistical verification) or each product (individual verification) conforms to the certified type and the applicable requirements of the directive.
• EC Declaration of Conformity: - Certificate directive that guarantees and declares that the production process or the quality of the product (Annex V-VI) is applied and conforms to the requirements of the quality system with respect to sterility.
EUROLAB, with its highly expert team and internationally accredited laboratories, Medical Device Safety Test It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
