BAS EN 455-4:2011
Medical gloves for single use - Part 4: Requirements and testing for shelf life determination
General Information
Status: Published
No. of pages: 19
Language: English
Edition: 1.
Adoption method: Endorsment
Publication date: 12.05.2011
Technical committee:
Directive:
93/42/EEC, Medical devices
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Abstract
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.
Lifecycle
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Original document and degree of correspondence
- EN 455-4:2009, identical