Laboratory Services According to IEC 60601-1 for the Medical Sector

Kiwa offers organizations the opportunity to engage Kiwa’s IECEE CB testing laboratory for conducting tests on electrical safety, electromagnetic compatibility, and all required functional tests that must be carried out in accordance with harmonized standards.

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Our experience makes us the market leader in the field of active medical devices for various applications: diagnostics/therapy, surgery, rehabilitation/physical therapy, and dentistry.

Kiwa’s accredited testing laboratory supports companies throughout the entire conformity assessment process—from the initial “risk analysis” phase through to “compliance”—by assisting with all subsequent trials and tests required to assess product conformity.

Electrical Safety

Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (DIN EN 60601-1; IEC 60601-1)

IEC 60601-1-11 / Medical electrical equipment for use in the home healthcare environment
IEC 60601-2-2 High-frequency surgical equipment and HF surgical accessories
IEC 60601-2-10 Nerve and muscle stimulators
IEC 60601-2-25 Electrocardiographs
IEC 60601-2-40 Evoked potential equipment
IEC 60601-2-46 Surgical tables
IEC 61010-2-040 Sterilizers and washer-disinfectors
IEC 61010-2-101 In vitro diagnostic (IVD) medical equipment

Electromagnetic Compatibility

Medical electrical equipment – Part 1-2: General requirements for basic safety; Collateral standard: Electromagnetic compatibility – Requirements and tests (IEC 60601-1-2)
Electrical measurement, control, regulation, and laboratory equipment – EMC requirements – Part 1: General requirements (IEC 65A/862/CD:2018, Part 1 of the international IEC 61326-1 standard series)

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Kiwa Primara Product Safety

Related services

QM Certification according to ISO 13485 for medical devices

ISO 13485 Medical Device Certification with Kiwa: Ensuring quality, building trust, and complying with regulations in the medical device sector.

Lifetime / MTBF

To provide reliable information about the expected reliability (failure behavior) of electronic products, calculating failure rates, MTBF (Mean Time Between Failure), or MTTF (Mean Time To Failure) of assemblies and devices is essential.We are specialized in the analysis of critical points of electrical assemblies and components as well as the lifetime analysis of power electronics in various industrial applications. We help you improve your product to increase customer satisfaction and sustainably enhance your reputation.