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prEN 455-2
Edition
04/2024
Medical gloves for single use - Part 2: Requirements and testing for physical properties
Medical gloves for single use - Part 2: Requirements and testing for physical properties
- € 20.60 / copy
Abstract
This document specifies requirements and gives test methods for physical properties of single-use medical gloves (i.e. surgical gloves and examination/procedure gloves) in order to ensure that they provide and maintain in use an adequate level of protection from cross contamination for both patient and user.
This document does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.
Status
| Draft - Active |
Origin
| Technical Committee : |
| CEN/TC 205 : Non-active medical devices |
Implementation
| start of the vote on the project | 12/01/2023 | date of ratification (dor) | 26/03/2024 | |||
| end of the vote on the project | 06/04/2023 | date of anouncement (doa) | 23/07/2024 | |||
| start of the vote on the final project | 02/01/2024 | date of publication (dop) | 23/10/2024 | |||
| end of the vote on the final project | 27/02/2024 | date of withdrawal (dow) | 23/10/2024 |
|
Publication Official Journal
of the Grand-Duchy of Luxembourg |
|
| Reference |
Relations
| Relations to older standards |
| ILNAS-EN 455-2:2015 |
International Classification for Standards (ICS codes) :
| 11.140 : Hospital equipment |
