IEC 60601-1-11 Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment

IEC 60601-1-11 medical device testing assesses mechanical strength. Specifically, it addresses the ability of medical devices to withstand the transportation hazards. Transit hazards can occur in shipping the devices. The shipping can be from the manufacturer to a distributer, health care provider or retailer. The hazards can also occur while the patient has the devices. It is important for medical devices manufacturers to complete the necessary package testing. This will reduce the amount of damage and returns that might occur.

Even the normal use of medical equipment in the home healthcare environment can be hazardous. Patients and their families, especially children, can be rough when handling equipment. To address these conditions, test methods have been designed based on the medical devices use categories. The IEC 60601-1-11 test standard assigned categories to devices. These categories are based on whether the equipment is designed to be stationary or moved during normal use.

Regardless of the end use or location of medical equipment, it must be transported. As a result, medical products will likely be subjected to mechanical stresses. These stresses can include vibrations and shock brought on by bumps and drops. These bumps and drops could be from loading and unloading the equipment onto transportation. They can also be incurred by just the transportation trip itself.

IEC 60601-1-11 transit testing has two main classifications of equipment. The first is non-transit-operable use. This is equipment that is not expected to be moved while in operation. The second classification is transit-operable. This is medical equipment whose intended use includes operation while it is being moved. Examples are devices attached to a wheelchair, body-worn or hand-held. Devices used in a car, boat, train, plane or bus are also considered in this classification.

Within the two main categories are several sub-categories. These include mobile, portable, hand-held and body-worn. The IEC 60601-11-1 package testing standard includes the following chart that displays the qualitative assessment of home healthcare medical equipment subjected to shock and vibration:

Non-Transit-Operable Use
MobilePortableHand-HeldBody-Worn
Vibration1111
Shock1111
Drop1132
Transit-Operable Use
MobilePortableHand-HeldBody-Worn
Vibration2221
Shock2232
Drop2233

Chart Key:

  • 1: Least severe mechanical strength test
  • 2: Moderately severe mechanical strength test
  • 3: Most severe mechanical strength test

It should be noted that some equipment can be interchangeable. It can be non-transit-operable in some settings but transit-operable in others. For instance, most body-worn equipment is considered transit-operable. However, if the device is for a bed-ridden patient, the device will be considered non-transit-operable. Another example is a portable ventilator. It can be intended for a seated patient (non-transit) or used while mounted on a wheelchair (transit). Ultimately, the choice between transit-operable and non-transit-operable is determined by the manufacturer. How the manufacturer describes the intended use in the instructions for use is key to the determination.

IEC 60601-11-1 transit testing states provides grey area in determining product failures. For instance, during testing, temporary interruptions of intended operation can be tolerated if consistent with essential performance. An example would be a breast pump. If an overflow cut-off switch can be easily reset by the patient after a mechanical disturbance, then this temporary interruption of intended operation was not likely to be considered an unacceptable risk.

Keystone Package Testing has extensive experience testing medical devices. Our team of engineers knows the hazards that can impact operations and help design a proper test plan. We do not over test a medical device. Nor do we under test them. When challenges occur, our team offers potential solutions to assist the manufacturer with meeting the requirements of the standard.

The customer experience our team provides is a big reason we have achieved award-winning growth and established a dominant presence in the market. Contact us today to learn firsthand why so many medical device manufacturers work with Keystone to meet their regulatory compliance needs.

 

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