The new UNE-EN 455-3: 2024 standard specifies the requirements and methods for evaluating the biological safety of medical gloves for single use, and also provides requirements relating to labelling and disclosure of the information relevant to the testing methods used.
This document relies on the following reference standards:
- UNE-EN ISO 10993-1:2020. Biological evaluation of medical devices. Part 1: Evaluación y ensayos mediante un proceso de gestión del riesgo.
- UNE-EN ISO 15223-1:2021. Healthcare products. Symbols to use with the information to be provided by the manufacturer. Part 1: General requirements
- UNE-EN ISO 21171:2006. Gloves for medical use. Determination of removable surface powder.
Similarly, we recommend consulting the CEN/TR 16953:2017 Technical Report if you are interested in receiving advice on the selection, storage and use of medical gloves for single use.
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