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Ingress Protection (IP) Testing in Gurgaon

Ingress Protection (IP) Testing in Gurgaon

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IP (IngressProtection) determines the devices ability to stop the intrusion of solidbodies and or liquid. The way to perform the relative test and the acceptancecriteria are subject to the IEC 60529. Relevant product standards can slightlychange test procedure and acceptance criteria. The IP Degree of a productis represented by the letters IP, followed by at least two digits.The first oneindicates the Degree of protection from solid bodies and the scale runs from 0(no protection) to 6 (complete protection, no ingress of dust).The second digitspecifies the Degree of protection from liquid and the scale runs from 0 (noprotection) to 8 (protection for long periods of immersion).While in the protectionfor solid bodies each designated degree implies the compliance of the test forall the lower degrees, in the protection against liquid intrusion, this worksonly for the degrees from 0 to 6.When To Define The IP Level Of Your MedicalDevices,The IP level of a medical device has to be defined early in the designand development process and it belongs to the product requirements, collectedbefore any designing activity begins.Among the many features influenced by IPrating, we can list, Housings divisions,Device thickness, Need of a gasket andconsequent need to reduce the internal volume,Orientation and position of anyopenings (e.g. holes, holes for connectors, air intakes),Electronic components.IPrequirements for a medical device can have significant impacts on the devicesdesign and the medical device development timeline if they are notproperly assessed early on. The risks to essential performance and patientsafety due to fluid ingress should be discussed and evaluated prior to architecturedefinition and enclosure design.  Once the risks are understood, themethods and design strategies to mitigate them can be explored, if mitigationsare needed at all.Design based mitigation strategies addressing ingressprotection for home healthcare medical devices may take the form of gaskets,adhesives, geometry changes, and meshes.  The designers and Medicaldevice engineers should also consider the impacts of these IP strategieson other parts of the system (cables, ventilation, user controls) and how theymight negatively affect other design requirements such as mechanical stress,thermal management, manufacturing viability, and product lifetime validation.Oneof the best strategies when brainstorming how to design ingress protected enclosuresis to study other consumer products that have an IP rating.  Some goodexamples include waterproof bike lights, car key fobs and waterproofheadphones.Following up with a robust testing strategy is crucial to ensure IPmitigations are effective.  Using rapid prototyping parts and materials toexpedite testing do not always provide an accurate representation of how thefinal material or process will perform during IP testing.  Solely relyingon prototyped parts may result in false positives or false negatives due to thedifferences in tolerances, surface textures, wicking properties and contactangles between materials and manufacturing processes.What To Consider In TheEngineering Of Your IP Rated Device,When you are approaching medicaldevice engineering, which includes the design and development of your IP ratedmedical device you will face three main aspects to take care of.Cleanability,If the device needs to be cleaned, having a completely sealed device may not berequired. In fact, sealing may actually cause cleaning failures. Sealing thedevice to IP68 may create small crevices where seals are located which couldallow bioburden to build up to unacceptable levels. Sealing through ultrasonicwelding or adhesives will require significant validation (both in terms ofcleaning, as well as the manufacturing process itself) and add cost to thedevice which may not be required.Orientation, If your device is pole mounted orhas its own cart, then the normal orientation of the Medical Device Development wouldbe always considered vertical, and a rating of IP x2 is likelysufficient. However, handheld or body worn devices may require asignificantly higher rating as the normal operating conditions of the devicemay be any orientation.Heat Dissipation
If the device generates heat, achieving high temperature, and air circulationis required, it may be challenging for engineers to meet high IP levels. Thedesign of the device will have to incorporate any heat dissipation strategiesthat meet the IP requirements of the device, and that is better done early inthe design cycle of the device.If you need expert advice with your next medicaldevice,CDG drives healthcare companies through the entire medical devicedevelopment process, from the earlier stages of requirements definitionand feasibility study to industrial design, medical device engineering andprototyping, up to contract manufacturing (certified with ISO 13485).Our medicaldevice engineers are used to develop devices with high IP rating such asfor example defibrillators and can bring your project to the market accordingto your specific requirements.Contact us and we will build with you thesuitable plan for your project and we will bring your idea to the market,together.

 

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