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SSH EN 455-4:2009

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

Apr 27, 2012

General information

60.60     Apr 27, 2012

DPS

DPS/KT 316

European Norm

11.140  

Scope

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.

Related directives

Directives related to this standards.

93/42/EEC

Medical devices

Harmonized

Life cycle

NOW

PUBLISHED
SSH EN 455-4:2009
60.60 Standard published
Apr 27, 2012

Related project

Adopted from EN 455-4:2009

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