scope:

This Amendment provides an updated Table 3 ""The median values of force at break"" to minimize the possible interpretation and misunderstandings regarding the values given in the appropriate table of EN 455-2:2009. Scope of the mother text: This European Standard specifies requirements and gives test methods for physical properties of single-use medical gloves (i.e. surgical gloves and examination/procedure gloves) in order to ensure that they provide and maintain in use an adequate level of protection from cross contamination for both patient and user. This 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.