EN 455 Explained.
In medical environments, gloves are essential for maintaining hygiene and the ability to maintain a level of user protection against harmful agents is assessed through consistent criteria. These criteria are aggregated into EN 455 Standards. When purchasing Work Gloves to be used for medical purposes, the importance of understanding EN standard 455 cannot be understated. EN 455 standards are created to ensure medical gloves used during medical examination and treatment can prevent the source of disease and / or poison from being cross-contagious between individuals.
For a glove to pass EN 455, it must pass a set of tasks that we are going to explain below.
What is EN 455?
EN 455 Medical Gloves for Single Use covers any glove that could be used for medical task. The glove must follow at least three to four independent parts before it is considered safe to be used for medical work. The completed set of four parts are:
- EN 455-1: Requirements and testing of gloves for freedom from holes
- EN 455-2: Requirements and tests for physical properties
- EN 455-3: Requirements and tests for biological evaluation
- EN 455-4: Requirements and testing for shelf-life determination
Fulfilling above parts should ensure that the glove will be a wall against micro-organisms, perform effectively without breaking, protect the user from poisonous and hazardous materials, and has longevity as designed.
EN 455-1: Requirements and testing for freedom from holes
This standard describes the test method in detail how the gloves should be tested for their physical resistance, and to be more specific, only a certain level of pinholes is allowed in the gloves if it is CE labelled as a medical glove. It could be performed via a watertight test, where the gloves are filled with 1 liter of water in a specific time. After the test was conducted, the gloves are checked. The higher the AQL level at the end of the test, the more pinholes were found. The result must meet an AQL of min. 1,5 to prove compliance with this standard. Most gloves will gain 1.5, however some more specialist gloves will reach 1.0 or even 0.65.
Why is EN 455-1 important:
EN 455-1 standard is crucial because we expect the gloves that we wear to be a wall, protect the users from cross-contamination. If the gloves have a lot of pinholes, this barrier is broken, even because of small pinhole, and we are no longer be protected. Since medical gloves are mass-produced, it is impractical to produce gloves without any failure. Gloves should be tested during manufacture and before shipment (not all are doing that, but it should be necessary). It is important that the minimum level of pinholes is kept, as the risk of getting an infection through the glove will be increased with a higher AQL level.
EN 455-2: Requirements and testing for physical properties
In this standard, you will find the requirements for the size of the glove and the durability of the glove.
This means exactly that you will find a table that explains the minimum conditions for the length and the width of a surgical glove, and you will find another with the same information for examination and procedure gloves.
There are also requirements to the durability of the glove, or more accurately how much force needs to be used to break the gloves or may be called the Force at Break.
These requirements are different for different types of material, as well as it is different for types of gloves (surgical or examination etc.).
The test method is described in detail, and the gloves must be tested after production and after a challenge test.
Something any user may want to avoid more than a leak during use, is a tear while using. It is common for cheaper latex gloves to be torn apart while donning. Makers of medical gloves have the challenge of creating a thin glove than will grip, be comfortable, and will fit close to your hand without tearing.
Understandably, there are different expectations of gloves that have different purposes. You cannot expect a glove made for a simple inspection to follow to the same standards as a glove designed to be used during surgical operation. The test pushes a force on the glove to measure when it will break. Below is the force needed for a glove to endure to fulfill.
- Type of Glove Force Needed to Break (Newtons)
- Surgical Gloves 9.0 Newtons
- Rubber examination gloves 6.0 Newtons
- Thermoplastic Gloves (Vinyl) 3.6 Newtons
Why is EN 455-2 important?
This standard is crucial to make sure that when you take out an examination glove with, for example size Medium from a box, that this glove would not be a size Small in another brand. On the other words, the sizing must be uniform. It is also important that the gloves are produced with a certain dimension, allowing the whole hand to be protected.
The durability of the glove is essential to make sure that the glove does not tear when you done the glove and if you use it for the intended use. The challenge test proves that the material under certain parameters will keep the durability.
EN 455-3: Requirements and testing for biological evaluation
This standard explains several areas that are important to make a biological evaluation on the gloves. It is the most complex of the 4 standards, because there are many different test methods mentioned and different requirements, and they are not only for latex gloves, but also relevant for all kinds of medical gloves.
There are numerous tests that must be made.
First there is the biological evaluation to see whether the glove will increase the risk of getting exposed or is an irritant to the user. This is completed by using 2 different parts of ISO 10993. The parts where the test methods are called are ISO 10993-5 and ISO 10993-10. Why these standards are used are based on the evaluation form ISO 10993-1, where a glove is found to be used on the surface of the skin, and in a shorter time.
The protein level of a latex glove should be examined using the revised Lowry test There are no needs for a minimum protein level in this standard. Other test techniques for protein level are stated in the extensions of this standard.
The powder level of a powder free glove should be tested using the method explained in ISO EN 21171. The powder level of a powder free glove cannot exceed 2 mg/glove. If the powder level is above that, the glove is considered a powdered glove.
Endotoxin level of a sterile glove can be tested. If you want to label your glove with a low content of endotoxin, the level must be below 20 EU/pair of gloves (EU=Endotoxin Units).
There are also labelling requirements in this standard, both specific for gloves, but reference to EN ISO 15223-1 is drawn.
When a manufacturer claims compliance to this part of EN 455, they must inform a user, if there are any chemicals added that are known to cause adverse health effects – upon request.
EN 455-3 may seem complicated, but it just covers what is needed to make sure the glove has undergone a proper biological evaluation before it is sold.
Although it is not a popular statement, but gloves are produced with a wide variety of chemicals, plastics, powders and irritants that may cause you harm. EN 455-3 exists to ensure that you are protected from the glove.
With four separate areas of analysis, EN 455-3 attempts to prevent the user from developing irritable skin, suffering an allergic reaction or gaining more serious diseases such as a fever. It is important to remember that there is always a risk of reacting to your glove, but EN 455 demands that the risk is as low as possible. The four tests are:
Chemical Residues: A test is conducted to understand the levels of chemical excess left on the glove from production.
Latex: Tests are performed to determine the latex protein levels on the glove. The higher the level of protein, there is more chance of irritable skin.
Powder: Powder-free gloves boast about their lack of potential irritants but must be tested to ensure they meet the correct specifications. A powder level that exceeds 2 mg/glove is considered enough for a powdered glove.
Endotoxin: Just for sterile gloves, the endotoxin must be checked. For a glove to pass as low endotoxin, the level must be below 20EU/pair of gloves (EU = Endotoxin Units).
Why is EN 455-3 important?
It is important because we want to make sure that the glove does not give you illness when you wear it. You should not be exposed by using it, and irritants should be so low as possible.
There will always be a risk of reacting to your glove, this risk must be low. If you react to your glove, you need to be able to find out, which glove to use instead. Here the standard also helps you, because you can ask for a list of the chemicals used in the glove.
EN 455-4: Requirements and testing for shelf life determination
All kinds of gloves have their certain shelf life. They need to be able to meet the first 3 mentioned standards during their shelf life. The reason of this test to be carried out, is to ensure the glove will not degrade while it is in transit, in a warehouse, or waiting to be used. Therefore, this standard defines how to test the shelf life of a glove, and how it should be labelled. There are 2 test procedures. The first one is the enhanced shelf-life determination. The glove is undergoing different challenge tests and based on the results of the test the theoretical shelf life is calculated. When the shelf-life determination is done based on the accelerated tests, the maximum years that can be claimed is 3 years. This test is normally made when a new glove product is introduced. At the same time, it is a must that the real-time shelf-life determination test is started, as the chemicals and proteins that have gone into a latex glove can decay over time. This will take years to complete – up to 5 years as this is the maximum shelf life for a glove.
Why is this standard important?
It is important that when you use the glove, that you know whether it still provides you the expected safeguard. Since a glove decomposes over time, it will only last for a certain period, when it is stored correctly.
You should not use the glove after the expiry date, as it may not give you the expected protection anymore.