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Electrical Safety (SEB)
Manufacturers of medical devices must ensure compliance with essential requirements in accordance with Medical Device Directive in order to place their products on the market. We test active medical devices for basic safety and essential performance according to IEC 60601-1 as well as for other applicable special specifications and collateral standards.
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We are accredited by the > DAkkS and recognized by the IECEE in the > CB Scheme.
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We support you in the creation of a test plan tailored to your requirements, both for normative tests and for developmen tests. Please introduce us to your product.
Our services in the field of safety of medical devices
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Research of relevant standards
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Safety tests
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Usability Assessment
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EMC tests
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Assessment of risk management
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Evaluation of medical software
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Laser classification
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Evaluation of accompanying documentation (instructions, technical descriptions, markings, construction)
Some standards for electrical safety testing
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IEC 60950-1
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IEC 62368-1
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IEC 60601-1
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IEC 60601-1-2
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IEC 60601-1-4
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IEC 60601-1-6
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IEC 60601-1-8
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IEC 60601-1-11
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IEC 60601-1-12
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IEC 60601-2-2
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IEC 60601-2-4
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IEC 60601-2-10
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IEC 60601-2-12
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IEC 60601-2-13
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IEC 60601-2-16
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IEC 60601-2-18
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IEC 60601-2-22
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IEC 60601-2-23
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IEC 60601-2-24
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IEC 60601-2-25
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IEC 60601-2-26
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IEC 60601-2-27
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IEC 60601-2-30
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IEC 60601-2-34
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IEC 60601-2-40
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IEC 60601-2-41
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IEC 60601-2-46
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IEC 60601-2-49
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IEC 60601-2-57
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ISO 80601-2-12
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ISO 80601-2-13
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IEC 80601-2-30
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IEC 80601-2-35
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ISO 80601-2-55
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ISO 80601-2-56
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IEC 80601-2-60
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ISO 80601-2-61
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ISO 80601-2-69
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ISO 80601-2-70
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ISO 80601-2-72
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ISO 81060-1
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IEC 60598-2-25
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IEC 61010-2-101
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Information technology equipment - Safety - Part 1: General requirements
Audio/video, information and communication technology equipment -
Part 1: Safety requirements
Basic standard - Medical electrical equipment
Collateral standard: Electromagnetic disturbances
Collateral standard: Programmable electrical medical systems
Collateral standard: Usability
Collateral Standard: General requirements, tests and guidance for alarm systems
Collateral Standard: Medical electrical systems used in the home healthcare environment
Collateral Standard: Medical electrical systems used in emergency medical services environment
Particular Requirements: High frequency surgical equipment and accessories
Particular Requirements: Cardiac defibrillators
Particular Requirements: Nerve and muscle stimulators
Particular Requirements: Lung ventilators - Critical care ventilators
Particular Requirements: Anaesthetic systems
Particular Requirements: Haemodialysis, haemodiafiltration and haemofiltration equipment
Particular Requirements: Endoscopic equipment
Particular Requirements: Surgical, cosmetic, therapeutic and diagnostic laser equipment
Particular Requirements: Transcutaneous partial pressure monitoring equipment
Particular Requirements: Infusion pumps and controllers
Particular Requirements: Electrocardiographs
Particular Requirements: Electroencephalographs
Particular Requirements: Electrocardiographic monitoring equipment
Particular Requirements: Automatic cycling non-invasive blood pressure monitoring equipment
Particular Requirements: Invasive blood pressure monitoring equipment
Particular Requirements: Electromyographs and evoked response equipment
Particular Requirements: Surgical luminaires and luminaires for diagnosis
Particular Requirements: Operating tables
Particular Requirements: multifunction patient monitoring equipment
Particular Requirements: Non-laser light source equipment intended for therapeutic, diagnostic,...
Particular Requirements: Critical care ventilators
Particular Requirements: Anaesthetic workstation
Particular Requirements: Automated non-invasive sphygmomanometers
Particular Requirements: Heating devices using blankets, pads and mattresses
Particular Requirements: Respiratory gas monitor (rgm)
Particular Requirements: Clinical thermometers for body temperature measurement
Particular Requirements: Dental equipment
Particular Requirements: Pulse oximeter equipment
Particular Requirements: Oxygen concentrator equipment
Particular Requirements: Sleep apnoea breathing therapy equipment
Particular Requirements: Home healthcare environment ventilators for ventilator-dependent patients
Non-invasive sphygmomanometers with non-automated measurement type
Luminaires for use in clinical areas of hospitals and health care buildings
Particular requirements for in vitro diagnostic (IVD) medical equipment