Training programmes
Our complete solutions in the field of medical devices include expert medical device compliance training programmes – interpretation of standards and regulations.
Testing and Certification of Medical Devices
Safety testing
We are able to provide the majority of safety tests under various loads or climatic conditions. We can adapt the procedures, logging, or test report according to customer requirements or specific test plans.
SIQ is a member of the international IECEE CB scheme. Medical standards within the scope of the IECEE CB scheme can be found here. We are accredited at Slovenian Accreditation (SA) for testing and certification according to standard IEC 60601-1 and EN 60601-1, which specifies general requirements for medical electrical equipment as well as for many other particular/collateral standards in relation to medical products.
- The main standard for safety: IEC/EN 60601-1 – Medical electrical equipment- Part 1: General requirements for basic safety and essential performance
Other particular/collateral standards:
EMC Technical Services
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).
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Environmental Simulations
The use of new technologies and increasing requirements for the reliability of products are the cause of the growing need for environmental impact testing. Our laboratory for environmental impact testing is adequately equipped to carry out various tests.
We are able to provide the majority of environmental tests according to various norms and standards under various loads or climatic conditions. We also offer the possibility of data logging and specific equipment for voltage/current drives.
Accredited methods according to the EN 60068 series:
- Vibration testing
- Climatic testing
- Salt-mist testing
- Altitude testing
- Parameter and functional testing
- Aging tests
- UV-light testing
CB Certification
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.
SIQ's accreditation
SIQ Medical Certification Mark
The Medical SIQ Certification Mark of conformity is a recognized safety and EMC mark for electrical products.
Our certificates facilitate access to domestic and international markets and form the basis for the EC Declaration of Conformity for your products. The SIQ Certification Mark tells consumers and relevant authorities that the product meets the requirements according to the listed standards on the product for safety and EMC (for example for power supply). Before granting a license for the use of the SIQ Certification Mark, SIQ performs a type test and a pre-license factory inspection.
After the license has been granted, SIQ performs regular annual factory inspections and follow-up product testing. Procedures for performing factory inspections and follow-up product testing are harmonized with those used within the CCA Scheme and in other foreign institutions. The level of confidence in the safety of devices bearing the SIQ Certification Mark is comparable to the level of confidence in the safety of devices bearing any other established European national certification mark.
International Approvals
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.
More about Approvals
Management System Assessment
SIQ offers a comprehensive range of services in the field of medical devices and also acts as a Notified body for certification according to Regulation MDR (EU) 2017/745, as well as an accredited certification body for various quality management systems (ISO 13485, ISO 15378,…).
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Want to know more?
We are looking forward to hearing from you and will be happy to get in touch to discuss further details.
