European standards for disposable gloves - EN 374, 455 and EN ISO 21420: 2019
European standards for disposable gloves
Disposable gloves are one Main component of the protective equipment in various professional sectors in which hygiene and patient protection play a major role. It is particularly important to wear disposable gloves in clinics, practices or in the food industry. When wearing disposable gloves, they not only protect the patients or customers but also themselves. Since there is a lot of value on infection protection, all disposable gloves on the market must go through special test procedures in order to be able to be sold as, for example, medical examination gloves. After the various test runs for disposable gloves, they receive a label which is also required by law.
In the following you will get insights into the necessary markings in your industry, the different test procedures and what identifies which labels.
What identifiers are there?
EN 455 - European standard I medical field
To identify the European standard 455 The disposable gloves must go through various tests. As soon as the disposable gloves have successfully passed the test runs, these may medical field be used. Disposable gloves without the EN 455 are not approved for the medical field because it is about the protection of the patients but also users from contamination.
The EN 455 can be divided into four different areas
- EN 455-1: tightness
- EN 455-2: Physical properties
- EN 455-3: Biological evaluation
- EN 455-4: durability
EN455-1 tightness of the disposable gloves
For infection protection, it is very important that the disposable gloves opaque to liquids and other secretions are. This not only protects the user of the disposable gloves but also the patient. The tightness of the disposable gloves is tested as follows: First, the gloves are hung in turn and filled with water until the material is tense. Furthermore, the gloves are inflated with air, held in the water and then it is observed whether air bubbles rise. With these test runs, checked whether holes are in the gloves. If this is the case, the faulty gloves are sorted out directly. The amount of sorted gloves is noted and evaluated. The result of this evaluation is with the AQL value given. You can find more about the AQL value below this article.
Since disposable gloves may no longer be sold, the tightness test only Random proceeded. The number of disposable gloves to be tested is specified for each security level.
CE Cat. I protective clothing for minimal risks
CE Cat. II protective clothing for medium risks
CE Cat. III protective clothing for high risks
EN455-2 physical properties
To check the physical properties, tests such as tear -resistant and stable The disposable gloves are. The European standard 455-2 also gives the required sizes and dimensions the disposable gloves. Disposable gloves that do not meet the exact requirements of the EN455-2 must not be applied in the operating room.
A distinction is also made between the applicable requirements OP gloves and Disposable gloves for the care of patients or for examinations. The EN 455-2 also specifies the dimensions of an examination glove.
EN455-3 Biological Assessment
A distinction is made between examination gloves between Nitrihl gloves, vinyl gloves, latex gloves and TPE gloves. It often happens that staff in the medical field Allergic on latex react. As an alternative to the latex gloves Vinyl gloves or nitrile gloves used. To protect users, according to the EN 455-3, the packaging of disposable gloves must be marked whether latex is included.
Powdered gloves ensure a better grip, but the application of unpowdered disposable gloves recommended, since many nurses or doctors usually react to powdering to an ignorant allergic. Therefore, in addition to the latex content, the powder must also be marked with a glove.
According to the EN455-3 the powder content may not exceed a maximum content of 2 mg powder. In addition, disposable gloves can be certified with the EN455-3 not be powdered with Talkum. More precisely information on the chemicals used, endotoxins, powder and the protein -detecting proteins must be Data leaves be specified.
EN455-4 durability of disposable gloves
On -the -wall gloves cannot be "bad"what one would probably associate with the term durability. Nevertheless, the material can be made from the disposable glove brittle become. The storage of gloves also plays a major role in durability. The manufacturer is therefore obliged to identify storage instructions on the packaging.
When testing the durability of disposable gloves, there are two methods.
- Acceleration of durability: The disposable gloves are heated in a special oven in order to simulate the aging process. Then they will be subjected to a few tests. If you pass this successfully, you will be with a preliminary expiry date of three years provided.
- Test in real time: As a rule, the maximum shelf life for disposable gloves is five years. In order for a disposable glove to be provided with a durability date of up to five years, this must be run through several different tests for five years. Become in the five years The same tests as for the EN455-1 and -2 applied.
EN374 - European standard for permeation and penetration
So that disposable gloves in some industries such as in Laborator or with the cleaning also resistant to chemicals must be, there is the EN ISO 374: 2016+A1: 218 or short EN 374. The disposable gloves are on the Consistency against chemicals and microorganisms tested. The disposable glove is intended to protect the user from irreversible health damage, so it is extremely important to check the packaging of the disposable gloves or have the labels before using disposable gloves in the laboratory.
The EN 374 is currently in five different stages Divided, each stage spends information about the checked area of application.
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EN ISO 374-1: 2016+A1: 2018: Performance requirements for chemical risks
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EN 374-2: 2019+A1: 2018: Penetration resistance
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EN 16523-1: 2015+A1: 2018 (formerly EN 374-3: 2003): Determination of the resistance of materials against the permeability of chemicals and liquid chemicals under the conditions of a continuous contact
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EN 374-4: 2019+A1: 2018: Consistency against degradation by chemicals
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EN ISO 374-5: 2016+A1: 2018: Protection against bacteria, mushrooms and viruses
EN ISO 374-1: 2016+A1: 2018: Performance request for chemical risks
The pictograms displayed above must be marked on EN374 certified disposable gloves. The standard only refers to protection against chemicals.
A distinction is made between Type A, B and C.
Type A: Protection against chemical breakthrough 6 Test chemicals for at least 30 minutes
Type B: Protection against chemical breakthrough 3 Test chemicals for at least 30 minutes
Type C: Protection against chemical breakthrough at at least a The test chemicals for at least 10 minutes
The Test chemicals With which of the disposable gloves the test has run through the manufacturer on the package of the gloves. The Identical letters are always below the pictogram Under the respective type.
In the table you will find the old and new test chemicals with the respective identification letter.
EN 274-2: 2019+A1: 2018: penetration resistance
To determine the penetration resistance, a Air-leak test and one Water-Leck test carried out. The disposable gloves are either filled with water or air until the material tenses. With the disposable gloves filled with water, it is checked whether water escapes. The disposable glove filled with air is kept in water, then it is observed whether air bubbles occur or not. If air bubbles occur, this points out that the one -off glove is not tight.
EN 16523-1: 2015+A1: 2018 (formerly EN 374-3: 2003): Consistency of materials against the permeability of chemicals
The permeation describes this Penetrating liquid or gaseous chemicals through a barrier. The breakthrough time indicates how long a chemical needs to get to the skin of the user by the protective layer of a disposable glove. Disposable gloves can be provided with different protective classes. It applies: The higher the protection class, the better the protection is.
EN 374-4: 2019+A1: 2018: Consistency against degradation by chemicals
The material from the disposable gloves can change through influence through chemicals. With the change in the material, for example, the decreasing elasticity or Tearfulness meant. The fourth part of the standard 374 should therefore provide information about this Whether and how long a disposable glove that has come into contact with any chemical can still be used. The standard is important to you if you have to work with chemicals every day, as it is important to know when you have to change your gloves.
The test procedure for the EN 374-4: 2019+A1: 2018 Certification expires as follows:
The disposable glove will One of the 18 Test chemicals (already listed above) for one hour exposed. Then it is then tested whether and how the Piercity of the glove.
EN ISO 374-5: 2016+A1: 2018: Protection against bacteria, mushrooms and viruses
The EN ISO 374-5: 2016+A1: 2018 has only been around since 2016, and protection against bacteria, fungi and viruses was included in the EN374-1.
The test procedures of the fifth part of the EN375 run similarly to the EN374-2. It will also be a Air-leak test and one Water-Leck test carried out. In addition, however, there is a test procedure in which the disposable glove of one Compositional fluid exposed becomes. The contamination fluid is with one Match the simulated virusthat can lead to an illness in a person.
If the glove passes the test successfully, it can be marked with EN ISO 374-5: 2016+A1: 2018 and demonstrably protects against bacteria, fungi and viruses.
EN420 becomes EN ISO21420: 2019
The EN ISO 21420: 2019 is used in combination with other European standards and ensures the correctness of the data provided by the manufacturer.
The standard specifies that the disposable gloves protect the user if the manufacturer prescribes it. In addition, the gloves must not cause health damage to the user or cause allergic reactions if they correspond to the manufacturer's information. An exact list of all materials used in the manufacture of the glove must be made available at the request of the consumer.
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