Certification mark for Good Dialysis Practice

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Adding value with our service portfolio

Certification mark for Good Dialysis Practice

Scope:

The certification mark applies to dialysis centres.

Basis of certification:

The certification mark is based on the ISO 9001 standard and, if requested by the customer, the ISO 14001 standard. In addition, the International Technical Report IEC 62653 “Guideline for safe operation of medical equipment used for haemodialysis treatments” is applied. Given this, the award of the certification mark covers assessment of the quality management system (QMS) and preventive safety measures.

Key words of the certification mark:

 

  • Blue Light Radio

    As LEDs and other blue-rich solid state light sources become dominate in domestic and workplace lighting, and as people spend more and more time staring at TV, computer, and mobile phone screens, blue light exposure will gradually increase, and its ocular hazards become more problematic. The evaluation of low blue light ratio is under specific low blue light mode of the product.

  • Long-term Use (RG0)

    Computer displays and display of Information technology equipment and Audio visual apparatus intended to be long-term use have been accessed by Exempt Risk Group(RG0) defined in IEC 62471.

  • Production monitored

    Periodic surveillance of the manufacture of a product constitutes the basic premise for certification which includes the award of a certification mark. Certification always requires product testing and regular factory inspections.

    As a third-party expert organisation, TÜV SÜD verifies that the manufacturer is able to maintain consistent quality in line with the requirements throughout high-volume production and has established the necessary quality system, including incoming goods inspections, lists of materials and final product check.

    In addition, calibration of the necessary measuring and monitoring equipment must be ensured. Surveillance and/or monitoring covers the testing of safety-critical components and other materials used. If unauthorised changes are made to the product, the certificate will be withdrawn and the TÜV SÜD certification mark may no longer be used.

  • Safety tested

    The voluntary TÜV SÜD certification mark with the statement “Safety tested” is awarded for products indicating that the product was tested and certified by the independent third-party organisation of TÜV SÜD Product Service for conformity with the essential technical safety requirements.

  • Flicker Free
    It can be predicted whether people will detect a homogeneously illuminated display appears to flicker or not by the amount of energy in the temporal frequencies of the display. The flicker assessment is based on the ISO 9241-307 standard.

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