The IEC 60601-1-11 medical device test evaluates mechanical strength. In particular, it addresses the ability of medical devices to withstand transport hazards. It focuses on problems that may arise in the transportation of devices.
The shipping may be from the manufacturer to a distributor, healthcare provider or retailer. Hazards can also occur while having sick devices. It is important that medical device manufacturers complete the required package tests. This will reduce the amount of damage and return that may occur.
Even normal use of medical devices in the home healthcare environment can be dangerous. Patients and their families, especially children, can be rude when using the equipment. To address these conditions, test methods are designed according to medical device usage categories.
IEC 60601 1 11 the test standard assigns categories to devices and these categories are based on whether the equipment is designed to be stationary or transported during normal use.
It should be carried regardless of the end use or location of the medical equipment. As a result, medicinal products will likely be exposed to mechanical stresses. These stresses can include vibrations and shocks caused by bumps and falls. These bumps and falls can be loading and unloading the equipment on transport. It can also be done only by the transportation trip itself.
The IEC 60601-1-11 transit test has two main equipment classifications. The first is the use that cannot be operated in transit. This is equipment that is not expected to be moved during operation. The second classification can be operated in transit. This is the medical device that contains the operation while its intended use is being carried. Examples are wheelchair-bound, body-worn or hand-held devices. Devices used in cars, boats, trains, planes or buses are also considered in this classification.
There are several sub-categories in two main categories. These include those that are mobile, portable, hand-carried and worn over the body. The IEC 60601-11-1 package test standard includes the following chart showing the qualitative evaluation of home health medical equipment exposed to shock and vibration:
| Mobile | Portable | Handheld | Wearable | |
| Vibration | 1 | 1 | 1 | 1 |
| Shock | 1 | 1 | 1 | 1 |
| Fall | 1 | 1 | 3 | 2 |
| Mobile | Portable | Handheld | Wearable | |
| Vibration | 2 | 2 | 2 | 1 |
| Shock | 2 | 2 | 3 | 2 |
| Fall | 2 | 2 | 3 | 3 |
It should be noted that some equipment may be interchangeable. In some settings, it can not be operated in transit, while in other settings, it can be operated in transit. For example, most body worn equipment is considered operable in transit. However, if the device is for a patient who is in bed, it will be considered that the device cannot be used in transit. Another example is a portable fan. It can be designed for a seated patient (non-transit) or used when mounted in a wheelchair (transit).
Ultimately, the choice between whether it can be operated in transit and not in transit is determined by the manufacturer. How the manufacturer describes the intended use in the instructions for use is the key to determining.
IEC 60601-11-1 transit test their status provides a gray area for the detection of product malfunctions. For example, during the test, temporary interruptions of the intended operation can be tolerated if it is consistent with basic performance. An example would be a breast pump. If an overflow cut-off switch can be easily reset by the patient after a mechanical discomfort, this temporary interruption of the intended operation is not considered to be an unacceptable risk.
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