Drop Testing Simulation For IEC 60601 Certification Compliance

SOLIDWORKS Simulation provides an environment where validating designs begins earlier in the design process. This allows designers to catch critical mistakes and make changes before any costly prototypes or certification procedures.

A failed certification can result in a setback in time and cost. To make designers more confident in their designs, SOLIDWORKS Simulation provides several tools that can help solve a range of simulations, from linear static analysis to non-linear dynamic studies. This article will go through an example of how SOLIDWORKS Simulation Professional can help make sure a design complies with the standard IEC 60601.

What is IEC 60601?

All electrically powered medical devices require a design capable of passing a drop test as defined by IEC 60601. This international standard confirms that medical devices are robust enough for the conditions that may occur during their lifetime. Without passing IEC 60601, medical devices cannot be sold by law. An accredited lab provides the certification once the design validates that it can be dropped on the ground from different orientations at a set height.

Why Drop Testing is Critical to Product Design

IEC60601 helps ensure the mechanical safety of medical devices. These medical devices are used in places such as hectic hospital rooms, home care environments, and fast-paced clinics. When moving urgently, devices might get knocked off tables, dropped by patients, or take a fall during transport. A device that is compliant with IEC 60601 demonstrates the ability to survive these types of impacts.

Drop testing answers questions such as:

• Will the case crack and expose internal electronic components?
• Will safety-critical systems be able to withstand a fall?
• Will the device still be reliable after impact?

Traditionally, drop testing has consisted of building prototypes and physically dropping them multiple times from different orientations. Not only can this be expensive, but it also slows down development, especially if a redesign and retest are required.

How SOLIDWORKS Simulation Can Help With Certification Standards

Simulations will not eliminate prototyping, but they can help minimize it. Sometimes getting an accredited lab to schedule a test can have some unexpected wait times. If a test is failed, another session will have to be rebooked at whatever openings are available.

This can be a very iterative process, but with drop tests in SOLIDWORKS Simulation, the process can be shortened drastically. Designers would use fewer prototypes to ensure a design can pass testing. This can be done by identifying weak spots early on, allowing for testing of multiple designs and materials, or running multiple drop scenarios. The fact that this is done virtually can help save time and money on the production of a prototype as well.

Drop Testing in SOLIDWORKS Simulation

SOLIDWORKS Simulation Professional has the capabilities to validate a virtual drop test. This allows engineers to predict how a device will behave under impact before a prototype is even built. By completing drop testing simulations in SOLIDWORKS, users can visualize stresses, strains, and deformations to see exactly where the design may fail.

SOLIDWORKS Simulation Drop Test Setup Manager

From these results, users can explore if different materials improve the design, adding reinforced ribs, or if alternative geometry can prevent the design from breaking. Simulations can also test different drop angles as required by IEC 60601. By running simulations in SOLIDWORKS, engineers can have fewer physical prototypes, and as a result, a lower material cost and a shortened development cycle. These benefits allow teams to enter certifications with confidence, all without producing a single piece of material.

Result plot from a SOLIDWORKS drop test

Ensuring Standards Compliance

Getting certified for IEC 60601 is a critical step for medical devices to be sold on the global market. IEC 60601 ensures devices are safe and reliable. SOLIDWORKS Simulation will never fully replace physical testing, but the drop testing capabilities give users a significant advantage by helping to find and fix problems earlier. The earlier in the design process issues are found, the less effort and cost it takes to resolve the problem.

To see how simulating drop testing can improve your designs, contact us here.