What is BS EN 455-151:2017?

BS EN 455-151:2017 is a technical standard that specifically applies to single-use medical gloves. It provides requirements and test methods for evaluating the biological safety of these gloves and ensures that they are fit for their intended purpose. Single-use medical gloves are widely used by healthcare professionals in various settings, such as hospitals, clinics, and laboratories.

Importance of BS EN 455-151:2017

BS EN 455-151:2017 plays a crucial role in ensuring the safety and effectiveness of single-use medical gloves. These gloves act as a barrier between healthcare providers and patients, preventing the spread of infections. By defining the requirements and testing procedures, this standard helps manufacturers in producing gloves that meet the necessary safety standards. Compliance with BS EN 455-151:2017 promotes confidence in the quality of medical gloves and helps protect both healthcare workers and patients from potential risks.

Components of BS EN 455-151:2017

BS EN 455-151:2017 consists of several components that contribute to its comprehensive evaluation of single-use medical gloves:

Biological Evaluation: This component assesses the biocompatibility of the glove material by considering factors like cytotoxicity, sensitization, irritation, and systemic toxicity. It ensures that the gloves do not cause any adverse reactions when in contact with the human body.

Microbial Barrier: This component tests the gloves' ability to prevent the passage of microorganisms. It evaluates parameters such as viral penetration, bacterial filtration efficiency, and microbial cleanliness to verify the effectiveness of the gloves in protecting against contamination.

Sterilization: If the gloves are intended to be sterile, this component ensures that the sterilization process has been properly validated and does not compromise the glove's integrity or performance.

In-Use Performance: This component focuses on factors such as tensile strength, elongation, and puncture resistance, which determine whether the gloves can withstand normal usage conditions and provide adequate protection during medical procedures.

Conclusion

BS EN 455-151:2017 is an essential technical standard that sets criteria for single-use medical gloves' biological safety. By evaluating their biocompatibility, microbial barrier, sterilization, and in-use performance, it ensures that these gloves meet the necessary quality standards. Compliance with this standard improves confidence in the safety and effectiveness of medical gloves, enhancing the overall protection of healthcare providers and patients.