CEN/TR 16953:2017

Medical gloves for single use - Guidance for selection

Publication date:   Feb 14, 2018

General information

60.60 Standard published   Nov 15, 2017

CEN

CEN/TC 205 Non-active medical devices

Technical Report

11.140   Hospital equipment

Buying

  Published

PDF - €36.30

  English   Bulgarian  



Buy

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 legislation

Legislation related to this standard

93/42/EEC

Medical devices

Life cycle

NOW

PUBLISHED
CEN/TR 16953:2017
60.60 Standard published
Nov 15, 2017