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 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 500000.
EN 455-2:2015 Referenced Document
EN 455-4:2009 Medical gloves for single use - Part 4: Requirements and testing for shelf life determination
EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (Remains Current)
ISO 188:2007 Rubber, vulcanized or thermoplastic - Accelerated ageing and heat resistance tests
ISO 23529:2010 Rubber - General procedures for preparing and conditioning test pieces for physical test methods
EN 455-2:2015 history
2015EN 455-2:2015 Medical gloves for single use - Part 2: Requirements and testing for physical properties
2009EN 455-2:2009 Medical gloves for single use - Part 2: Requirements and testing for physical properties
2000EN 455-2:2000 Medical Gloves for Single Use - Part 2: Requirements and Testing for Physical Properties Including Technical Corrigendum 1:1996; Supersedes EN 455-2:1995; Best Copy Available-Per BSI
1998EN 455-2:1998 Medical Gloves for Single Use - Part 2: Requirements and Testing for Physical Properties Includes Amendment A1: 1998; Incorporates Corrigendum June 1996
1995EN 455-2:1995 Medical Gloves for Single Use - Part 2: Requirements and Testing for Physical Properties (Incorporating Corrigendum June 1996; Incorporates Amendment A1: 1998)