TS EN 455-1 Disposable Medical Gloves - Features and No Holes

The EN 455-1 standard, which describes the requirements and test methods for disposable medical gloves features and lack of holes, is actually a European standard. This standard is designed for disposable medical gloves and describes the requirements and test methods for getting rid of holes.

In fact, the EN 455 series of standards is a series of standards, consisting of four parts, under the general heading of disposable medical gloves. This series of standards has been published in our country by the Turkish Standards Institute (TSE) with the following titles:

• TS EN 455-1 Part 1: Properties and no hole test
• TS EN 455-2 Part 2: Rules and experiments for physical properties
• TS EN 455-3 Part 3: Properties and experiments for biological evaluation
• TS EN 455-4 Part 4: Rules and experiments for determining shelf life

The EN 455 set of standards supports the essential requirements or other provisions of the medical devices directive 93/42 / EEC.

This part of the EN 455 standard uses a water leak test technique, which is carried out using the AQL statistical sampling method (acceptable quality level method) based on standard production batch sizes.

Requirements for single-use gloves for the protection of workers engaged in medical interventions are clearly defined. However, the traditional medical distinction between sterile surgical gloves used in surgical procedures and disposable medical gloves used in non-sterile medical fields is not fully defined. There are different requirements between these two areas of use. If sterility is not required, sterilization of disposable medical gloves is not performed. Therefore, another concept should be found to define the safety quality of non-sterile disposable medical gloves.

Within the scope of protective clothing tests, TS EN 455-1 disposable medical gloves features and absence of holes are also provided by our organization.