This Technical Report provides information for those choosing or using sterile and non-sterile gloves for medical applications based on a risk assessment. It deals with gloves worn primarily for the protection of the patient and glove user from biological cross contamination. NOTE Gloves worn specifically for the protection of the glove user from e.g. chemical and biological hazards are covered by the EU-Directive on Personal Protective Equipment (PPE) and the related standards e.g. EN 16523-1, EN 374-2, EN 374-4, EN ISO 374-1 and EN ISO 374-5. This document describes the rationale behind the requirements of the EN 455 series and explores the possible trade-offs in glove selection between the various factors which affect glove, physical properties, biocompatibility, comfort and sensitivity. The strengths and weaknesses of various alternative glove materials and the potential biological hazards presented by their use are also explored.
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EN 455-1:2020 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
EN 455-1:2020+A1 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
EN 455-1:2020+A1:2022 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
EN 455-1:2020 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
EN 455-1:2020+A1 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
EN 455-1:2020+A1:2022 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
EN 455-2:2015 Medical gloves for single use - Part 2: Requirements and testing for physical properties
EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
EN 455-3:2023 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
EN 455-4:2009 Medical gloves for single use - Part 4: Requirements and testing for shelf life determination
EN ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
EN ISO 10993-10:2023 Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
EN ISO 374-5:2016 Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks (ISO 374-5:2016)
ISO 2859-1:1999 Sampling procedures for inspection by attributes -- Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection