Testing and Certification of Medical Devices

We are professional, accurate, and responsive in meeting your requirements for electromagnetic compatibility testing and certification. Our measurements, test reports, and certificates assure EMC compatibility of your product in all important markets. We provide our professional assistance at the earliest stages of development when we can perform partial, critical tests on individual devices.

SIQ is a part of the international IECEE CB EMC scheme. In SIQ EMC laboratory, our skilled EMC test engineers with their experience with various medical devices can perform all required tests on specific equipment dedicated to EMC testing of medical devices.

• IEC/EN 60601-1-2 – defines the basic and essential performance of medical equipment with regard to electromagnetic disturbances.
• EN 61000-3-2 – Limits for harmonic current emissions (equipment input current ≤ 16 A per phase).
• EN 61000-3-3 – Limitation of voltage changes, voltage fluctuations, and flicker in public low-voltage supply systems, for equipment with rated current <= 16 A per phase and not subject to conditional connection.
• EN 303 446-1 – Standard for combined and/or integrated radio and non-radio equipment (only applicable to products containing radio modules).
• FCC testing – Testing according to 47 CFR Part 15 Subpart B to cover requirements for the US market.
• IEC/EN 61000-4-39 – Radiated fields in close proximity (simulates intentional radio services).

The IECEE CB Scheme is an international system for the mutual recognition of test reports relating to the safety of electrical and electronic products.
The CB certificate is a document certifying that the product meets the requirements of the relevant IEC standard. SIQ operates within the CB Scheme as a recognised National Certification Body (NCB) and a Recognised Testing Laboratory (CBTL), thus awarding CB Certificates of Conformity and associated CB Test Reports.
A manufacturer who has a CB Test Report from any of the national CB Scheme Certification Bodies can obtain a national certificate from any other CB Scheme member country.

A large number of countries around the world still have mandatory national certification requirements. This means that the products must be approved in the respective countries before they can be imported and put on the market.

The rapid changes resulting from globalization and competition present technical barriers and a serious problem for the industry. Problems arise due to time to market, a reduced life cycle of products, and the need to reduce costs.

SIQ can provide you with assistance and help you obtain specific certificates to enter various markets and countries. We have built trustworthy partner relationships with many NRTLs and can offer to obtain international certificates on the basis of our CB test reports and certificates so your products can reach any desired market.

You can find more information per country here or contact us for detailed information and specific requirements regarding your particular product and chosen target market.