Validation

The high hygienic requirements for the medical offices and the accompanying inspections by the authorities make compliance with the legal specifications and requirements with regard to a validated reprocessing process for medical devices unavoidable.

The MPBetriebV prescribes in §8

'' ... the reprocessing of medical devices intended for low-germ or sterile use shall be carried out with appropriate validated procedures, taking into account the manufacturer's instructions, in such a way that the success of these procedures is comprehensibly guaranteed and the safety and health of patients, users or third parties is not endangered..."

The legal situation is therefore clear and operators must comply with the framework conditions to avoid severe penalties.

It is not the patient who has to prove that the operator is the causer, but the operator who has to prove that his medical device, e.g. instrument, could not cause any damage!

The initial validation of a device should take place immediately after the device has been put into operation.

ic safely into future validierung

Attention, these requirements only apply in Germany. Please observe the regulations and requirements in your country and the responsible authorities with regard to validation.

IC Medical GmbH offers the following brand-independent validation services:

  • RDG (thermal disinfectors) based on the DGSV guideline according to EN 15883
  • Sealing devices based on the DGSV guideline according to DIN EN ISO 11607-2 Revision
  • Sterilizers (B-class) based on the DGSV guideline according to EN 13060
  • W&H Assistina 3x3 (Testing only in combination with RDG (thermal disinfector) or sterilizer)
  • Seal seam stability test

ic validierungsprotokoll

Attention, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it. to make sure that we can perform a brand-independent validation in your medical office.

Seal seam stability test

In addition to the validation of sealing devices, the authorities and guidelines of relevant institutes recommend an annual inspection of the sealing seams for tensile strength. The seal strength test is subject to a standardised test procedure and specific requirements. The performance of the sealing seam and the safety of the sterile packaging are assessed using a calibrated test procedure and confirmed with an expert opinion.

Please fill in the form for the seal seam strength test and proceed as described therein. This way we can guarantee that we have all the information and film samples you need to test the seal strength.

Please send us the completed order form and the test samples of the film types you have produced by post to

    IC Medical GmbH
    Schorndorfer Straße 67
    73635 Rudersberg-Steinenberg

After a few days you will receive your test report!

Attention, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it. to make sure that we can perform your seal seam stability test.

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February 21st till 23rd 2019
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March 12th till 16th 2019
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