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

رقم المستند: NL EN 455 4 : 2015
القطاع: Health Care Technology
TC: NL TC 3001
ICS:
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.