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DS CEN/TR 16953:2017

Medical gloves for single use - Guidance for selection

Apr 11, 2018

General information

60.60     Jan 18, 2018

DPS

DPS/KT 205

Technical Report

11.140  

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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.
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.

Related directives

Directives related to this standards.

93/42/EEC

Medical devices

Life cycle

NOW

PUBLISHED
DS CEN/TR 16953:2017
60.60 Standard published
Jan 18, 2018

Related project

Adopted from CEN/TR 16953:2017