UNI EN 455-1:2022
Specifies the requirements and provides the test method for the examination gloves in order to determine their freedom from holes.
UNI EN 455-2:2015
Specifies the requirements and provides the test methods for the physical properties of disposable medical gloves to ensure an adequate level of protection for both the patient and the wearer against mutual contamination during their use.
UNI EN 455-3: 2015
Specifies the requirements related to the evaluation of the biological safety of disposable medical gloves. It provides requirements for labeling, packaging, and disclosure of information regarding the test methods employed.
UNI EN 455-4:2009
Specifies the requirements for the shelf-life of disposable medical gloves.
UNI EN ISO 10993-5
Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity. Describes the test methods for evaluating the in vitro cytotoxicity of medical devices.
UNI EN ISO 10993-10
Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization. Describes the procedure for evaluating medical devices and their constituent materials for their potential to produce irritation and skin sensitization.
Standard test method for resistance of materials used in protective clothing to penetration by blood-borne pathogens using the viral penetration as a test system. Describes the properties of penetration resistance and test methods for materials used in the manufacturing of protective clothing.
Describes the test methods for performance and safety of nitrile rubber medical gloves used in medical examinations, diagnostics, and treatment procedures.
Describes the test methods for performance and safety of latex medical gloves used in medical examinations, diagnostics, and treatment procedures.
UNI CEI EN ISO 15223-1:2017
Requirements and symbols for the labeling of medical devices.