BS EN 455-3:2015
Medical gloves for single use. Requirements and testing for biological evaluation

Standard No.

BS EN 455-3:2015

Release Date

2015

Published By

British Standards Institution (BSI)

Status

Be replaced 2023-12

Replace By

BS EN 455-3:2023

Latest

BS EN 455-3:2023

Replace

BS EN 455-3:2006

BS EN 455-3:2015 Referenced Document

• 93/42/EEC Commission communication in the framework of the implementation of the Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance; Publication of titles and references of harmonised standards under the directive)
• 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 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
• ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
• ISO 14971:2007 Medical devices - Application of risk management to medical devices
• ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
• ISO 21171:2006 Medical gloves - Determination of removable surface powder

BS EN 455-3:2015 history

• 2023 BS EN 455-3:2023 Medical gloves for single use - Requirements and testing for biological evaluation
• 2015 BS EN 455-3:2015 Medical gloves for single use. Requirements and testing for biological evaluation
• 2007 BS EN 455-3:2006 Medical gloves for single use — Part 3: Requirements and testing for biological evaluation
• 2000 BS EN 455-3:2000 Medical gloves for single use - Requirements and testing for biological evaluation