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Language
ILNAS-EN 455-4:2009
Edition
07/2009
Medical gloves for single use - Part 4: Requirements and testing for shelf life determination
Medical gloves for single use - Part 4: Requirements and testing for shelf life determination
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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.
Status
| Standard - Active |
Origin
| Technical Committee : |
| CEN/TC 205 : Non-active medical devices |
Directives
|
93/42/EEC : Medical devices
|
Implementation
| start of the vote on the project | 15/03/2007 | date of ratification (dor) | 20/06/2009 | |||
| end of the vote on the project | 15/08/2007 | date of anouncement (doa) | 31/10/2009 | |||
| start of the vote on the final project | 19/03/2009 | date of publication (dop) | 31/01/2010 | |||
| end of the vote on the final project | 19/05/2009 | date of withdrawal (dow) | 31/01/2010 |
|
Publication Official Journal
of the Grand-Duchy of Luxembourg |
14/03/2011 |
| Reference | Mémorial A N° 47 |
International Classification for Standards (ICS codes) :
| 11.140 : Hospital equipment |
