EN 455 is a European standard that contributes to ensuring the safety and reliability of medical gloves (exclusively gloves) and meeting an accepted level of quality. This standard establishes requirements regarding fit, performance, processing, as well as labeling and packaging.
We will also take a look at the different types of gloves according to EN 455, the use of disposable gloves, and explain the importance of EN 455. In the end, we will discuss the tests that need to be conducted to ensure a glove complies with EN 455.
EN 455 Overview & Basics
EN 455 is a European norm specifically developed for medical gloves used in medical facilities and healthcare settings. It consists of four parts, namely EN 455-1, EN 455-2, EN 455-3, and EN 455-4. Each part of the norm addresses specific requirements and test procedures. Medical disposable gloves that comply with European Standard 455 are tested for the following points:
EN 455-1 establishes the requirements and test procedures for the physical properties of disposable gloves. This includes aspects such as dimensions, thickness, tensile strength (whether a disposable glove is leakproof), and elongation. These properties are crucial to ensure that the medical gloves have an appropriate fit while providing sufficient freedom of movement.
EN 455-2 deals with the requirements for testing the permeability resistance of disposable gloves. This part of the norm is particularly important to ensure that the gloves form a barrier against potentially infectious materials and chemicals. Various test procedures are applied to evaluate permeability resistance and ensure that the gloves offer the required protection.
EN 455-3 addresses the requirements and test procedures for the biological evaluation of disposable gloves. This evaluation is important to ensure that the gloves are free from harmful microorganisms and allergenic substances. Thorough investigations are conducted to ensure the biological safety of the gloves and minimize the risk of infections or allergic reactions.
Lastly, EN 455-4 deals with the requirements and test procedures for determining particle residues on disposable gloves. This part of the norm aims to ensure that the gloves are free from particles and contaminants that could potentially be hazardous. Various test procedures are applied to verify the cleanliness and purity of the gloves.
Importance of EN 455
This standard measures the leakage that can occur through a certain number of gloves in a specific time period by setting an Acceptable Quality Level (AQL) for medical gloves, such as 1.5 or 2.5.
If the leaks exceed a certain threshold, it means that the gloves can no longer be recognized as protective equipment. Therefore, it is important for gloves to have an AQL of, for example, 1.5 or 2.5, so that they are not only safe but also effective.
This means that the leaks through the gloves should be lower than the specified values to ensure a good level of safety. To ensure that gloves comply with the requirements of EN 455, comprehensive tests need to be conducted.
Here are some of the gloves from our range.
Testing Procedures
To ensure that gloves meet the requirements of EN 455, tests must be conducted to ensure their safety.
This includes, among others:
- A testing component that examines the size and cuff of the glove.
- A testing component that ensures the glove provides adequate protection.
- A testing component that checks the elasticity of the fabric.
- A testing component that measures the glove’s resistance at temperatures ranging from -5°C to +50°C.
- A testing component that verifies the glove’s single-use capability.
These tests provide insights into whether the glove complies with the requirements of EN 455 and is therefore safe for use. If the tests are successfully completed, the glove receives labeling according to EN 455.
EN 455-1: Physical Properties of Medical Disposable Gloves
EN 455-1 defines the criteria and test methods for the physical properties of medical disposable gloves. These properties are crucial to ensure that the gloves provide a good fit while ensuring the necessary protection.
An important aspect covered by EN 455-1 is the size and dimension of the gloves. The standard specifies that gloves should be available in various sizes to ensure a snug and comfortable fit for different hand sizes. Furthermore, specific requirements are set for the length, width, and thickness of the gloves to ensure they offer sufficient protection without restricting movement.
Tensile strength and elongation are also important physical properties outlined in EN 455-1. The gloves should have adequate strength to prevent tears or holes during use. At the same time, they need to have a certain degree of stretchability to provide a comfortable fit and freedom of movement. Test procedures are applied to evaluate the tensile strength and elongation of the gloves and ensure they meet the requirements.
The European standard EN 455-1 also establishes requirements for the materials used in glove manufacturing. The selection of materials for the gloves is crucial to fulfill the intended purpose, whether it’s protection against infections or chemicals. The standard sets specific requirements for the materials, including their physical properties such as elasticity and resistance to penetration.
EN 455-2: Permeability Resistance of Medical Disposable Gloves
The EN 455-2 standard establishes the requirements and test procedures for the permeability resistance of medical gloves. This aspect is of great importance to ensure that medical disposable gloves provide an effective barrier against potentially infectious materials and chemicals.
According to EN 455-2, various test procedures are applied to evaluate the permeability resistance of the gloves. This includes tests for puncture resistance to assess whether the gloves can withstand punctures from sharp objects. Tests for liquid penetration are also conducted to ensure that the gloves are resistant to blood, bodily fluids, and other potentially hazardous substances.
The standard specifies that the gloves must not have any leaks or tears, and no liquid should penetrate through them. This is crucial to minimize the risk of disease transmission and protect healthcare professionals from potential hazards.
By complying with the requirements of European Standard 455-2, manufacturers can ensure that their medical disposable gloves have effective permeability resistance. This allows healthcare professionals to perform their work safely and reduces the risk of infections.
EN 455-2 thus plays a significant role in ensuring the quality and safety of medical disposable gloves. It is important for healthcare professionals and healthcare facilities to ensure that the gloves used meet the requirements of this standard to ensure the highest level of protection.
EN 455-3: Biological Evaluation of Medical Disposable Gloves
EN 455-3 defines the requirements and test procedures for the biological evaluation of medical disposable gloves. This part of the standard is crucial to ensure that the gloves are free from harmful microorganisms and allergenic substances.
According to EN 455-3, various tests are conducted to ensure the biological safety of the gloves. This includes checking for microbial contamination to ensure that the gloves are free from pathogens. Sensitization tests are also performed to ensure that the gloves do not trigger allergic reactions.
The standard specifies that the gloves must meet certain requirements to be classified as biologically safe. They must not contain harmful microorganisms and should be free from known allergens. This is crucial to minimize the risk of infections or allergic reactions in patients and healthcare professionals.
By meeting the requirements of EN 455-3, manufacturers can ensure that their medical disposable gloves provide the necessary biological safety. This ensures the health and safety of patients and healthcare professionals.
EN 455-3 is therefore an important component of the standards that ensure the quality and safety of medical disposable gloves. It is important for healthcare professionals and healthcare facilities to ensure that the gloves used meet the requirements of this standard to minimize the risk of infections and allergic reactions.
EN 455-4: Determination of Particle Residues in Medical Disposable Gloves
EN 455-4 is an important standard that addresses the determination of particle residues in medical disposable gloves. This standard is particularly relevant for powdered disposable gloves and sterile disposable gloves used in medical settings.
EN 455-4 ensures that the gloves are free from harmful particles and contaminants that could potentially be hazardous. During the manufacturing and packaging process of disposable gloves, particles can be generated, which may pose a contamination risk over time. By complying with EN 455-4, these particle residues in the gloves are reduced to an acceptable minimum.
Compliance with EN 455-4 is especially crucial for sterile disposable gloves. Sterile gloves are used in sensitive medical environments such as operating rooms or during invasive procedures. Contamination with particles can increase the risk of infection for patients and healthcare professionals. The determination of particle residues according to EN 455-4 ensures that the gloves meet the required cleanliness standards.
Manufacturers of medical disposable gloves must ensure that their products comply with the requirements of EN 455-4. Medical facilities and professionals should pay attention to the conformity with this standard when selecting gloves to ensure the safety of patients and healthcare personnel.
EN 455-4 contributes to gloves being free from particles and contaminants that could potentially be hazardous. Compliance with this standard ensures the quality and safety of medical disposable gloves used in medical settings.
Conclusion
In conclusion, EN 455 is an important standard that ensures the quality of gloves and ensures that consumers receive a safe and reliable product. We have learned about the different types of gloves as well as the EN 455-4 durability standard and the testing procedures.
It is of great importance for manufacturers and buyers to adhere to the EN 455 guidelines to ensure they receive a safe and reliable product. This standard plays a crucial role in the quality assurance of gloves.
If you are looking for medical disposable gloves in various materials and colors that comply with European standards, you’ve come to the right place! Here you will find our range of different disposable gloves. Click here to browse our product categories.
FAQ
What is EN 455?
EN 455 is a European standard that defines the requirements for medical disposable gloves.
How many parts does EN 455 consist of?
EN 455 consists of a total of four parts: EN 455-1, EN 455-2, EN 455-3, and EN 455-4.
What does EN 455-1 regulate?
EN 455-1 establishes the requirements and test procedures for the physical properties of medical disposable gloves, such as size, tear resistance, and elongation.
Which aspects does EN 455-2 address?
EN 455-2 addresses the requirements and test procedures for the permeability resistance of disposable gloves to ensure they provide a barrier against potentially infectious materials.
What does EN 455-3 include?
EN 455-3 addresses the biological evaluation of disposable gloves to ensure they are free from harmful microorganisms and allergenic substances.
What does EN 455-4 regulate?
EN 455-4 sets the requirements and test procedures for determining particle residues in disposable gloves to ensure they are free from harmful particles and contaminants.
Are powdered disposable gloves still permissible according to EN 455?
No, according to EN 455, powdered disposable gloves are no longer permissible as the powder can cause particle residues and potential allergy risks.
Why is compliance with EN 455 important?
Compliance with EN 455 is important to ensure the quality, safety, and performance of medical disposable gloves and to minimize the risk of infection for patients and healthcare professionals.
Who is responsible for compliance with EN 455?
Manufacturers of medical disposable gloves are responsible for complying with the requirements of EN 455 to ensure their products meet the standards.
How can I ensure that the disposable gloves I use comply with the requirements of EN 455?
You should ensure that the disposable gloves you use are labeled as “EN 455 compliant” and meet the individual parts of the standard. If in doubt, you can contact the manufacturer or supplier to obtain further information.
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