A Guide to IEC 60601 Testing for Custom Medical Carts

Anyone who works in the medical field knows how vital a medication cart can be to your work. You will also know that an effective medical cart must be properly tested against official regulations to ensure it meets all the necessary standards regardless of whether it is a standard or custom cart. Follow these tips to adhere to proper 60601 testing for your custom medical cart.

The purpose of 60601 testing

The International Electrotechnical Commission has set up standards that are used to assess the safety of medical equipment. These standards ensure the equipment is safe for both the patient and those operating it.

Each 60601 standard has its own application. When addressing the tests that are required for a medical cart, you must remember how and why the cart will be used.

The cart should be mobile, easy to transport, and safe for use in the same area as a patient. It will, therefore, need to undergo the tests that have been designed for these factors rather than the tests used for handheld or wall-mounted medical equipment.

Each test should show you whether the cart is safe to use in its primary purposes.

Durability of markings

The decals you use for marking your medication cart are important for the safety of all professionals working with the cart as well as the patients. Make sure the warnings and other markings are durable and will not wear away as the cart is used.

The durability of the markings is tested using special substances determined by the 60601 regulations. The chemicals chosen should give a representation of the wear the decals will go through as the cart is used in various medical situations.

If the labels and markings start to become worn to the point they cannot be read, this means they are not durable enough to be considered safe. The labels must also remain securely affixed to the cart after the chemicals have been applied and cannot start to peel away.

Testing the markings

The substances used to test the markings are distilled water, methylated spirit, and isopropyl alcohol. Each of them is to be applied to the decals with a cloth rag.

Soak a rag in the water first, then apply to the decal for 15 seconds. Do not press too hard. After this, repeat the test with the methylated spirit, and then with the isopropyl alcohol. Each substance should be applied in the same way, for the same amount of time.

Visual assessments

When testing the legibility of your markings, note the visual acuity of the tester. This issue is also important when you assess whether you have placed the decals and markings in the correct areas of the cart to be easily read and understood by the operator.

The standard for this is based on an operator with 20/20 vision, using the cart in a normal manner. Anyone assessing the legibility of the cart markings should have this level of eyesight.

Stability when being transported

The ability to be transported easily is vital for an efficient, effective medical cart. The caster design should permit the cart to move quickly from one point to another while also remaining stable. The cart should move smoothly, and not be in any danger of tipping over as it is transported. Moving quickly and smoothly ensures the cart is safe and getting to the necessary location in a convenient amount of time.

If the cart is in danger of tipping as it is transported, this presents a danger to the person moving it, as well as those in the immediate area. It also means the turnaround time for the cart’s use is greatly reduced, limiting the work of the medical professionals who need it.

Testing transport stability

When testing your medical cart’s stability during transportation, you will need to use it with the casters in a locked position. Locking the casters allows you to recreate how it would normally be transported.

With the casters in a locked position, the cart should be placed on an incline of 10-degrees. Make sure to determine that the incline is at the correct angle.

If the cart tips at all, the design must be reassessed and adjusted. If it does not tip, then this aspect is determined as safe.

Stability with unintentional movement

When the cart is in its transportation setting, it should be able to maintain its position. Maintaining its position means that it must remain stable, without moving or sliding, when placed on an incline.

For this test, similar conditions are required to the ones used for the transportation test. You will need a surface with an incline of 10-degrees on which to test the cart.

The casters must be in a locked position. While in this locked position, the cart may move slightly, but only up to a maximum of 50 mm. This movement does not include the movement that might occur as the casters themselves settle into position.

Stability with unintentional movement

Force needed for movement

One of the primary purposes of a medical cart is its mobility. As well as maintaining its safety when being transported, it should not require too much effort to move. Different personnel in a medical facility may need to move and use a medical cart, and they should not need to overexert themselves.

The standard force used to move a medical cart is measured at less than 45 lbs. Using less than 45 lbs of force means you should be able to move the cart with relative ease using only 45 lbs of pressure. If more force is required to move the cart, the operator may have to strain when pushing it, creating a safety hazard.

Stability when pushed over a threshold

Frequently, transporting a medical cart means it must be pushed over a threshold, such as you might find in a doorway. While these can be shallow, some might be steep enough to cause difficulty in moving the cart.

If you struggle to push the cart over a threshold, the time spent moving the cart will be extended. Taking the extra time to move the cart could have serious consequences in an emergency.

In addition to the extra time spent moving the cart, the operator might be forced to push harder to get the cart over the threshold. Not only does this pose a potential physical risk to the person transporting the cart, but it could increase the danger of the cart tipping over and being damaged.

Testing threshold stability

To test the stability of a medical cart as it is pushed over a threshold, you must create conditions according to 60601 standards. These conditions are using a threshold of at least 10 mm above the level of the ground, held down securely.

You are required to maintain the speed of .8 m per second as you perform the test, to give an accurate representation of how the cart might be transported. The cart must be able to move over the threshold while being transported at a normal pace, without any additional uncontrolled force such as a sudden push.

Make sure to give yourself enough space in front of the threshold to get the cart up to the correct speed. The test must be repeated multiple times to ensure accurate results.

Stability when static

When in a non-transport setting, the medical rolling cart must be able to remain stable. When testing this, you need to use an incline, similarly to the transport test, although you only need to use an angle of 5-degrees. During the test, the cart should be in no danger of tipping.

Stability with unintentional movement when static

This test is similar to the transportation test, using the 5-degree incline permitted for non-transport settings. With locked casters, the cart should not move more than 50 mm when on the sloped surface.

As with the transport test, the cart may be permitted to move a little initially, as the casters shift around as gravity pulls the cart. The wheels themselves, however, cannot move or slide after this small movement.

Remember to repeat the test with the cart placed at different angles on the slope. Using multiple angles allows you to test the castors in every direction.

Stability under pressure

It is important to ensure the cart is in no danger of tipping over when it is in use. This means it must remain stable when any external force or pressure is applied to it. There are two different types of force you will need to measure, horizontal and downward.

Horizontal force means pressure from the side, such as is used to push the cart. However, you must test the danger of tipping from a force from any direction, as someone may push or knock into the cart from any side.

Downward force means pressure placed on top of the cart, such as someone leaning on it. Both types of forces must be tested to ensure the stability of the cart.

The force you use is dependent on the weight of the cart. The force must be equal to 15% of the cart’s weight, for each horizontal and downward test.

Withstanding shock and damage

A medical cart may be used in emergencies and might need to be transported from one area to another as quickly as possible. Although staff should be trained to do this safely, many hazards may not be clearly marked. Unmarked hazards lead to an increased chance that a collision may occur.

With speed involved, there is a risk of damage to the cart if it is pushed into a wall or door while being transported. You must test to determine whether it can hold up against the shock of this impact.

You will also need to measure the cart’s capacity for handling shock by moving it onto a threshold 40 mm off the ground and pushing it off again. While this is higher than the threshold test for transportation, you must check whether the cart can withstand the jolt of rapid ascent and descent from this height.

medical cart

Impact testing

When testing impact, you should be aware of the appropriate transport speed for your medical equipment cart. You must move the cart as fast as you usually would, at .8 m per second, for an accurate test.

You must also test the cart by pushing it in the manner you would normally transport it. With the easy maneuverability of carts on casters, you may not be limited to a specific direction of travel. However, you should note how it would usually be pushed and imitate this for the test.

You can test the durability of the cart by running it into a door frame at test conditions using a suitable transport speed. There should be no damage that will render the cart unsafe or unusable after the impact has occurred. The cart should be able to withstand multiple shocks of this nature as part of the same test.

Strength of materials

The tensile safety factor determines part of the safety of the medical cart. Having the proper tensile safety means the tensile strength of the materials is appropriate for the weight they are expected to carry.

The weight you anticipate the cart carrying will be defined as its normal load. Make sure this weight has been accurately determined before the test takes place.

The tensile safety factor may vary for the different materials used to create different parts of the cart. This variance is because certain parts have specific functions depending on the use of the cart and may be required to carry varying loads.

The materials themselves may also be subject to different tensile safety regulations. If a material is exceptionally brittle, it has a higher risk of breaking under pressure. These materials require a more stringent safety rating.

Additional testing

As well as its physical purpose, it is important to remember the medical cart is generally used for its electronic capabilities. In addition to the physical tests mentioned above, it should be tested for electronic safety.

These tests must be performed with both the safety of the operator and the safety of the patient in mind. There should be no danger of voltage transfer to the patient from any part of the cart they might access.

The operator should also be able to use the cart with no concern for electronic safety. However, any electronic testing should be done with the possible weakness of the patient in mind. Depending on the medical conditions involved, a patient may be at far greater risk of the effects of a shock than the medical personnel treating them.

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