Medical Products, Tensile Strength (EN 455-2)

Hand Protection Equipment Tests

Medical Products, Tensile Strength (EN 455-2)

The EN 455-2 standard, a European standard, describes the physical properties and test methods of disposable medical gloves. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN 455-2 Disposable medical gloves - Part 2: Rules and experiments for physical properties.

Medical Products, Tensile Strength (EN 455-2)

Covering these disposable medical gloves, the EN 455 standard consists of four parts:

  • TS EN 455-1 Part 1: Properties and no hole test
  • TS EN 455-2 Part 2: Rules and tests 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 455-2 standard provides the requirements and current test methods that medical gloves must meet to prevent cross contamination.

Basically, this standard concerns companies that produce disposable medical gloves, suppliers and users of these products.

This part of the standard covers the physical properties of disposable medical gloves such as surgical gloves and examination gloves. The recommendations in the standard are intended to ensure that gloves provide adequate protection from cross contamination during use for both the patient and the wearer. The maximum achievable individual lot size for the manufacture of these gloves is 500 thousand.

In the latest update of the standard, nitrile exception has been introduced for values ​​of center breaking strength.

In short, the EN 455-2 standard describes the length and width dimensions of disposable medical gloves and physical properties such as tensile strength before and after heat aging.

Although this standard was originally prepared to support the medical devices directive, several changes were made subsequently to enable CE marking as personal protection equipment.

Medical products, breaking force (EN 455-2) testing services are also provided by our organization within the framework of hand protection equipment testing services.

 

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