CEN/TR 16953:2017:fi

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Scope

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. NOTEGloves 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.

The standards writing body responsible for this document in Finland is General Industry Federation.

Table of contents

Product group(s)

11.140 Hospital equipment »

Relationships

Normative references

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

Technical committee

CEN/TC 205 Non-active medical devices »

Directive

93/42/EEC Medical devices

http://ec.europa.eu »

Date of implementation

24.11.2017

Published

12.11.2019

Edition

Pages

Language(s)

Finnish/English