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БДС EN 455-4:2010

Medical gloves for single use - Part 4: Requirements and testing for shelf life determination

Aug 20, 2010
Jan 15, 2019

General information

90.60     Jun 4, 2019



European Standard


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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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for labelling and the disclosure of information relevant to the test methods used. This European Standard applies to existing, new and significantly changed designs. Existing designs that do not currently have ageing data available should generate that data within a reasonable period of time. 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.


Medical devices


Life cycle


БДС EN 455-4:2010
90.60 Close of review
Jun 4, 2019

Related project

Adopted from EN 455-4:2009