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Product groups - medical / x-ray equipment
Complex diagnoses and therapy methods contribute to a high patient benefit. At the same time, patients, users and third parties must be protected from potential risks arising from the use of medical equipment, but still its efficiency must be guaranteed. When launching medical devices on the market, manufacturers are required to perform conformity assessments in accordance with the risk class of their product. Every medical device launched on the market must meet "basic requirements".
SLG as notified body tests and certifies the conformity with a documented model in batch tests or within the framework of an approved quality assurance system. Such a conformity assessment process is the precondition for the CE marking and, if required, for the use of the notified body's registration number.
Our accreditation scope covers the following products:
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respiratory, gas therapy and inhalation devices |
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surgical and auxiliary surgical devices |
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dental devices |
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devices for imaging techniques |
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devices for the determination and control of vital parameters |
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devices for disinfection and sterilisation |
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medical care units |
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ophthalmological devices |
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patient bedding and transport equipment |
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rehabilitation devices and active prostheses |
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stimulation current, acupuncture devices, defibrillators |
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x-ray diagnosis and radiation therapy devices |
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