Medical Electrical Equipment must comply with some generic and with other relevant standards in order to obtain specific certifications and be marketed (e.g. CE mark for Europe).
Test for Medical Electrical Equipment
Besides Electric and Electronic Tests, two of the most common and considerable tests to verify the compliance with requirements of a Medical Electrical Equipment, and to support the medical certification, are the Drop Test and IP Test.
IP Test for Medical Devices
IP (Ingress Protection) testing determines the device’s ability to stop the intrusion of solid bodies and/or liquid. The way to perform the test and the acceptance criteria are subject to the IEC 60529.
Relevant product standards can slightly change test procedure and acceptance criteria. The IP Degree of a product is represented by the letters IP, followed by at least two digits.
The first one indicates 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 digit specifies the Degree of protection from liquid and the scale runs from 0 (no protection) to 8 (protection for long periods of immersion).
While in the protection for Solid Bodies each designated Degree implies the compliance of the test for all the lower degrees, in the protection against liquid intrusion, this works ONLY for the degrees from 0 to 6.
Drop Test for Medical Devices
Drop test is aimed to verify the absence of unacceptable risks after a series of falls, and through this, the reliability and the resistance of the ME Equipment.
IEC 60601-1 requires the compliance with a Drop Test for Hand-Held equipment and Portable ME equipment as well for Hand-Held parts and Portable parts of ME equipment.
Hand Held ME equipment (or parts) must withstand a series of free fall from 1 meter accordingly the condition indicated in IEC 60601-1, while the height of the falls for Portable Me equipment are much smaller, between 2 and 5 cm (it depends to the mass of the ME Portable equipment / parts).
Relevant product standards (IEC 60601-2-…) for specific family of products can change the conditions (number and directions) and height of fall.
Creanova Supports You in Testing Your Medical Project
Creanova’s product engineers during the engineering phase improve the designed solutions through iterative steps of drop test and IP test (partial and complete) on prototypes.
Testing on prototypes allows to evaluate a behavior close to the final one in production and are performed till the validation of the solutions. Creanova’ s product engineers perform or attend to all these healthcare devices tests, in house or in our partners’ laboratories, for a better understanding of the possible fails and a better and faster evaluation of the improvements.
Our team of experts gives support throughout all these tests, from the preliminary ones, to those for the pre-compliance till those for the certification, helping the process for the validation of medical projects to go as much fast and smooth as possible.
Corpuls AED is one of the ME Equipment that have benefited of our product engineers’ expertise to withstand a multiple free fall extended to a 150 cm height and to reach the IP 66 degree (no dust and no water after 3 minutes under a powerful waterjet of 100 l/min), one of the highest and difficult IP Degree, all inside strict limits of dimensions an weight.
All these requirements have been achieved thanks to smart and wise use of a combination of sealing systems, structural barriers, fixing solutions and deformable areas, as well a specific research of materials.