What is BS EN 45518: 2017

BS EN 45518: 2017 is a technical standard that specifically addresses the safety requirements for medical gloves. The standard was developed by the British Standards Institution (BSI) and provides guidelines for manufacturers to produce gloves that offer adequate protection against various risks in healthcare settings.

Scope and Purpose

The scope of BS EN 45518: 2017 covers both natural rubber latex and synthetic gloves used in medical applications. It defines the minimum performance requirements and testing methods for evaluating the protective properties of these gloves. The purpose of this standard is to ensure the safety of healthcare professionals and patients by setting standards for glove manufacturing.

Requirements and Testing

Under BS EN 45518: 2017, medical gloves must comply with several requirements related to physical properties, barrier performance, biocompatibility, and labeling. These requirements include specifications for glove sizes, tensile strength, elongation, puncture resistance, and protein content in latex gloves.

To evaluate compliance, the standard outlines specific testing methods such as visual inspection, air inflation, water leak test, and determination of glove powder content. Additional tests are conducted to assess biological safety, including cytotoxicity, sensitization, irritation, and bacterial penetration.

Compliance and Certification

Manufacturers seeking compliance with BS EN 45518: 2017 must perform extensive testing and demonstrate adherence to the specified requirements. Gloves meeting the standard's criteria can be certified and marked with the relevant conformity symbol indicating their compliance. This certification ensures that the gloves provide an appropriate level of safety for healthcare workers and patients.