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MDD and the law of health care equipment and supplies require that a risk must be removed and if it is not possible, the risks must be minimized. What does it mean in practical use? For example, a debilitated patient’s risk factor cannot be increased in any way. Equipment equipped fans recycle dust, bacteria and viruses – and also from one room to another. One hospital bacterial epidemic spread costs much more than the procurement difference between cheap office computers and high quality medical computers through out the whole department.

Laws and regulations are made for the protection of the patient and the user. Each and everyone of us should have a safe environment with in the hospital, regardless of where the hospital is located or the size of the hospital budget.

  • After installation or subsequent modification, an ME SYSTEM shall not result in an unacceptable RISK.
  • Only HAZARDS arising from combining various equipment to constitute an ME SYSTEM shall be considered.
  • NOTE: RESPONSIBLE ORGANIZATIONS are reminded that the assembly of ME SYSTEMS and modifications during the actual service life require evaluation to the requirements of this standard.
An ME SYSTEM shall provide:
  • within the PATIENT ENVIRONMENT, the level of safety equivalent to ME EQUIPMENT complying with this standard; and – outside the PATIENT ENVIRONMENT, the level of safety equivalent to equipment complying with their respective IEC or ISO safety standards.
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About us
Werth Systems is a Manufacturer of IT Solutions for the  Healthcare Market. Our engineers have more than 20 years of knowledge in fanless Computerdesigns and they are specialized in developing of safe systems for the Patient Environment.