Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.
Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards.
Validating the specifications, value and safety of your raw materials, products and assets.
Over the course of the last several months, this blog has explored the multiple variables associated with risk management as it relates to Third Edition. But what about support systems? A support system is a part of the medical equipment intended to support loads or provide actuating forces. As a result, medical device manufacturers need to be aware of the hazards associated with support systems.
Support systems are tested based on Tensile Safety Factors which are given in Table 21 of the standard. If the materials tensile strength, maximum load of the material can support without fracture and all external forces are known, then the lower values of column A can used for the test. Some examples of external forces to consider include: Static or Dynamic Forces, Vibration, Impact, Pressure Loading, Temperature, Environmental, etc. If this items are not accurately know then the more severe values of column B are used.
The test load from column A will be from 2.5 to 8 times the load rating of the support system. The test load from column B will be from 4 to 12 times the load rating of the support system.
If you have any questions or comments for our experts, please include these below. You also can visit www.intertek.com/medical to learn more about suspended masses as it relates to Third Edition.