Manufacturers of medical devices must ensure compliance with essential requirements in accordance with MDD 93/42 / EEC 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. In addition, we are a member of the > Third Party Test Data Program of Unterwriters Laboratories (UL).
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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