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EVS-EN 455-4:2009

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

General information
Valid from 08.10.2009
Base Documents
EN 455-4:2009
Directives or regulations
93/42/EEC Medical devices (MDD)
Standard history
Status
Date
Type
Name
08.10.2009
Main
This part of EN 455 specifies requirements for shelf life for medical gloves for single use. It also specifies the requirements 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.
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