This part is intended the close the gap that meant that non-critical medical devices were not covered see Fig. It applies to both single-use medical devices and the reuse of medical devices. Examples of such devices would anesthesia equipment, parts of an ultrasound machine, blood pressure devices, ECG cables, handles of surgical lights. They should pay particular attention to the: Choice of geometry Areas that are hard to reach must be avoided so that cleaning, disinfection and sterilization can be performed more easily.
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This part is intended the close the gap that meant that non-critical medical devices were not covered see Fig. It applies to both single-use medical devices and the reuse of medical devices.
Examples of such devices would anesthesia equipment, parts of an ultrasound machine, blood pressure devices, ECG cables, handles of surgical lights.
They should pay particular attention to the: Choice of geometry Areas that are hard to reach must be avoided so that cleaning, disinfection and sterilization can be performed more easily.
This affects, for example, cavities bag lumens, thin lumens , open mechanisms and transitions edges, seams. Requirements resulting from processing If there are areas that cannot passively be reached by detergents and disinfectants, these areas must be actively rinsed e. Choice of materials Choosing the right materials in crucial in two ways: Firstly, they must easy to process.
Secondly, they must be able to survive a lot of processing cycles without compromising mechanical or biological safety. For example, materials that become porous are more difficult to clean, disinfect and sterilize. Choice of processing procedure A lot of developers design their devices based on its intended purpose in order to optimize its benefits. The choice of processing procedure takes a back seat. In general, mechanical processing is always preferable. Mechanical processing can have consequences for the design of the device.
But manufacturers should also consider the risks that are present even if the processing is performed according to the specifications. So they should test detergents and disinfectants for critical ingredients. Special tests make it possible to sufficiently demonstrate the biocompatibility of detergents and disinfectants. Notified bodies are increasingly asking how it is ensured that no production residues e.
If the process chemicals were defined and controlled more precisely, this would be less of a problem or even not a problem at all. This saves redundant and thus unnecessary time and costs, e. Worst case scenarios have been proven to be successful. Worst case refers, e. Incomplete risk analysis The manufacturer or the laboratory does not analyze the risks associated with the choice of detergents and disinfectants. In particular, their effects on the service life of the device are not systematically investigated and documented.
The same applies for risks from detergent and disinfectant residues. Lack of usability assessment Testing laboratories evaluate whether the processing instructions are suitable. This is because the detergents used target other residues. We see residues from production that cause problems even after processing on devices again and again. Validated processing does NOT replace verification of biocompatibility. Due to a potential build-up of residues and potential material changes brittleness, corrosion, etc.
This is only possible if biocompatibility is taken into consideration. Please read the article on biocompatibility to see how to avoid unnecessary tests, regulatory problems and risks to patients.
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Gagami Is there already a reprocessing manual? The principles of ISO Both documents are landmarks in terms of implementation of the requirements regarding manufacturer surveillance. Our scientific director classifies the results of the test report for you in this assessment. For those medical devices where instructions for use are not required to accompany the medical device, other means of communicating the information can be used, e. Involve HygCen at an early stage in the review of your healthcare reprocessing process. Preparers of medical devices are also subject to legal obligations.
ISO 17664 PDF