prBAS EN 455-2:2025
Medical gloves for single use - Part 2: Requirements and testing for physical properties
Opšte informacije
Status:Projekt
Broj stranica:14
Metoda usvajanja:Proglašavanje
Jezik:engleski
Izdanje:2.
Datum realizacije:22.10.2024
Predviđeni datum naredne faze:12.03.2025
Tehnički komitet:BAS/TC 25, Zaštita zdravlja
Direktive:
2017/745, Uredba (EU) o medicinskim sredstvima
ICS:
11.140, Bolnička oprema
Apstrakt
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.
Životni ciklus
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EN 455-2:2024, identičan
Veza sa BAS standardima
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