What is BS EN4550:37-2017?

BS EN4550:37-2017 is a technical standard that pertains to the safety of medical gloves used in healthcare settings. The main aim of this standard is to ensure that the gloves provide an effective barrier against biological contaminants, such as bacteria and viruses, thus reducing the risk of infection for both healthcare professionals and patients.

Mandatory Requirements under BS EN4550:37-2017

This technical standard sets out several mandatory requirements that medical gloves must meet in order to comply with it. Some of the key requirements include:

Biocompatibility: Medical gloves should be made from materials that do not cause adverse reactions when in contact with human tissue or skin.

Physical Properties: Gloves should possess adequate strength, elongation, and puncture resistance to withstand normal use without tearing or rupturing.

Barrier Performance: The gloves must form an effective barrier against microorganisms, ensuring that no leakage occurs during typical glove usage.

Freedom from Holes: Gloves should be free from holes visible to the naked eye, ensuring that there are no weak points in the glove material.

Testing and Compliance

In order to ensure compliance with BS EN4550:37-2017, medical glove manufacturers are required to perform a series of tests on their products. These tests include:

Visual Inspection: Each glove should be visually inspected for defects or irregularities.

Air Leakage Test: Gloves are filled with air or a liquid, and any leakage is detected by observing bubbling or pressure changes.

Tensile Strength Test: The glove material is stretched until it breaks to determine its strength and elongation properties.

Puncture Resistance Test: A sharp probe is used to measure the force required to puncture the glove material.

Benefits of BS EN4550:37-2017 Compliance

Compliance with BS EN4550:37-2017 brings several benefits for both healthcare professionals and patients. Some of these benefits include:

Enhanced Safety: Medical gloves that comply with this standard provide a reliable barrier against pathogens, reducing the risk of cross-infections in healthcare settings.

Improved Quality Assurance: Manufacturers who adhere to this standard can ensure that their gloves meet specific quality requirements, enhancing customer confidence.

Regulatory Compliance: Compliance with BS EN4550:37-2017 is often a prerequisite for marketing and selling medical gloves in many countries, ensuring adherence to legal and regulatory frameworks.