SR EN 455-4:2009

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

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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General information

Status : Valid
Approval date : 12/15/2009
Publish date : 12/17/2009
Romanian version publish date : 11/30/2011
Number of pages : 22
ICS : 11.140 Hospital equipment
Technical Committee : 377 - Medical devices

Relations with other standards:

Normative reference SR EN ISO 11607-2:2006
Normative reference SR EN 455-1:2003
Normative reference SR EN 1041:2009
Normative reference SR EN 455-2:2010
Normative reference SR EN 455-3:2007
Normative reference SR EN ISO 11607-1:2009