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.
Our experience makes us a market leader in the field of active medical devices for various applications: diagnostics/therapy, surgery, rehabilitation/physiotherapy, and dentistry.
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As an accredited testing laboratory, Kiwa supports companies throughout the entire conformity assessment process – from the initial phase of “risk analysis” to “compliance,” including all additional trials and tests that must be conducted to evaluate 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)