Views: 24 Author: Site Editor Publish Time: 2022-03-18 Origin: Site
Different industries have different standards for casters, and generally caster manufacturers will conduct relevant tests on their own casters according to industry standards,Some common tests are shown below, including load, step (usually around 5-6mm, different from the IEC test mentioned later), brake force, stiffness, deflection test, etc.
The designer can contact the manufacturer according to his design requirements to see if the relevant tests meet the design requirements of the med device, or ask the manufacturer to do the relevant tests if necessary, provided that both parties agree on the relevant costs and time.In addition, you can also custom caster, the most common is to change the color, of course, the premise is also the two sides agree on the cost and expectations, the larger the development company, the greater the expected number of negotiating power, the smaller the company no one loves to ride.
Testing of Med Equipment
IEC60601-1 is the basic safety and basic performance requirements for med electrical equipment, which can be considered as the general rules of med device requirements, and many countries will develop their own standards based on it, such as China's GB9706.1.For subdivided types of med devices can be considered applicable if there is no specific label.In the 3rd edition of IEC60601-1 involving casters, the following tests are mainly:
For the aforementioned equipment with a high center of gravity, passing instability tests (Instability) is difficult. Although designers can use a variety of methods to solve this problem, such as increasing the diameter of the chassis, shaped chassis and lower the center of gravity, etc., but it is best to evaluate the design early in order to make the appropriate measures as soon as possible.
A few more words about the test of passing the step (Movement over a threshold), because the elevator in the hospital can not be completely flush with the floor when it stops, more or less there will be steps.Up the steps will cause difficulties for the movement of med equipment, after all, you can not always rely on the manual to pull.Therefore, version 3 of the standard 9.4.2.4.3 a new requirement, the intention is that a small step (20mm) does not affect the normal speed of the equipment (0.4 m / s) through, is to be able to smoothly cross this step without causing any risk.
However, this requirement brings great design difficulties to various med device companies, because it is difficult to pass this test for equipment with a caster diameter of 125mm or less, and increasing the caster often brings increased costs and instability of the entire device.So in version 3.1, perhaps after listening to a wide range of opinions that this requirement is too harsh, the IEC committee reduced the 20mm to 10mm and increased the speed of passage from 0.4 m/s to 0.8 m/s, finally allowing relevant manufacturers and designers to breathe a sigh of relief.In addition, version 3.1 also has higher requirements for the thrust of the instrument, which will not be elaborated here.
IEC for the applicability in individual countries will not be discussed here, but once applicable, the tests it specifies are actually the minimum requirements for med devices.Many med device companies also have to conduct reliability testing, or have more stringent corporate requirements than it, and it is entirely possible that different products may have different requirements due to different intended uses. Even if the test passes, it does not mean that the risk is acceptable, and often risk management and FMEA (Failure Mode and Effects Analysis) are also required for evaluation and control.