This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labelling and the disclosure of information relevant to the test methods used.
EN 455-3:2015 Referenced Document
EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing
EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
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)
EN ISO 21171:2006 Medical gloves - Determination of removable surface powder (ISO 21171:2006)
ISO 14971:2007 Medical devices - Application of risk management to medical devices
EN 455-3:2015 history
2023EN 455-3:2023 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
2016EN 455-3:2015/PRA1:2016 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
2015EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
2006EN 455-3:2006 Medical Gloves for Single Use - Part 3: Requirements and Testing for Biological Evaluation
1999EN 455-3:1999 Medical Gloves for Single Use - Part 3: Requirements and Testing for Biological Evaluation