SIS-CEN/TR-16953 Medical gloves for single use - Guidance for selection

SIS-CEN/TR-16953 - 2018 EDITION - CURRENT


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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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11.140 (Hospital equipment Including hospital beds, surgical tables, medical garments, medical gloves, containers for sharp disposal, etc.)

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Designation Name

SIS-CEN/TR 16953:2018

Revision Level

2018 EDITION

Status

Current

Publication Date

Dec. 20, 2017

Language(s)

English

Page Count

32