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БДС EN 455-2:2015

Medical gloves for single use - Part 2: Requirements and testing for physical properties

Jul 16, 2015
May 15, 2017

General information

90.93     Mar 18, 2021

90.00    Mar 18, 2026

BDS

ТК-87

European Standard

11.140  

English   Bulgarian  

Безплатният достъп е въз основа на Решение 15/20 от 2020 г. от извънредна онлайн сесия на Председателския комитет на CEN/CENELEC за предоставяне на стандарти на CEN и CENELEC, необходими за улесняване на алтернативното производство на лични предпазни сред

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Scope

This European Standard 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 European Standard 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.

Directives and Regulations

When the standard is harmonized under a directive or regulation, the word Harmonized appear. When such an inscription does not appear, it means that the standard is related to / supporting the relevant directive or regulation.

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
БДС EN 455-2:2009+A2:2013

NOW

PUBLISHED
БДС EN 455-2:2015
90.93 Standard confirmed
Mar 18, 2021

REVISED BY

IN DEVELOPMENT
prБДС EN 455-2:2023

Related project

Adopted from EN 455-2:2015