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.
BS EN 455-3:2006 Referenced Document
EN 1041 Information supplied by the manufacturer of medical devices*, 2013-09-01 Update
EN 980 Graphical Symbols for Use in the Labelling of Medical Devices
EN ISO 10993 Biological Evaluation of Medical Devices - Part 9: Framework for Identification and Quantification of Potential Degradation Products
EN ISO 14971 Medical devices - Application of risk management to medical devices (ISO 14971:2019)*, 2021-12-08 Update
EN ISO 21171:2006 Medical gloves - Determination of removable surface powder (ISO 21171:2006)
BS EN 455-3:2006 history
2023BS EN 455-3:2023 Medical gloves for single use - Requirements and testing for biological evaluation
2015BS EN 455-3:2015 Medical gloves for single use. Requirements and testing for biological evaluation
2007BS EN 455-3:2006 Medical gloves for single use — Part 3: Requirements and testing for biological evaluation
2000BS EN 455-3:2000 Medical gloves for single use - Requirements and testing for biological evaluation