EN 455: Medical gloves for single use
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DIN EN 455-1:2020+A1:2022: Medical gloves for single use - Part 1: Requirements and testing for leakage
Scope of application
This standard defines the requirements and test methods for single-use medical gloves. It does not specify requirements for chemical resistance. In this respect, reference is made to EN 374-1 "Protective gloves against chemicals and micro-organisms".
Classification
DIN EN 455 consists of four parts. They specify various requirements for gloves that protect the user against contamination.
EN 455-1: Requirements and testing for leakage
This standard specifies the test method and requirement for leak tightness and acceptable quality limit (AQL).
EN 455-2: Requirements and testing of physical properties
This standard specifies requirements and test methods of the physical properties of single-use medical gloves.
EN 455-3: Requirements and testing for biological evaluation
This standard describes requirements and test methods for the assessment of the biological safety of disposable medical gloves as part of risk management in accordance with EN ISO 14971 and EN ISO 10993, as well as for labelling and providing information on the test methods used.
EN 455-4: Requirements and testing for the determination of minimum durability
This standard specifies requirements for the shelf life of single-use medical gloves, their labelling and the disclosure of information relevant to the test methods.