CEN/TR 16953:2017

Medical gloves for single use - Guidance for selection

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.

Medizinische Einmalhandschuhe - Leitlinien für die Auswahl

Gants médicaux non réutilisables - Lignes directrices pour sélectionner des gants médicaux non réutilisables

Medicinske rokavice za enkratno uporabo - Smernice za izbiro

To tehnično poročilo podaja informacije za tiste, ki izbirajo ali uporabljajo sterilne in nesterilne rokavice za medicinsko uporabo na podlagi ocene tveganja. Obravnava rokavice, ki se nosijo predvsem za zaščito bolnika in uporabnika rokavic pred biološko navzkrižno kontaminacijo.
OPOMBA: Rokavice, ki se nosijo izključno za zaščito uporabnika rokavic pred npr. kemičnimi in biološkimi nevarnostmi, so zajete v direktivi EU o osebni zaščitni opremi (PPE) in povezanih standardih npr. EN 16523 1, EN 374-2, EN 374-4, EN ISO 374-1 in EN ISO 374-5.
Ta dokument opisuje utemeljitev za zahteve v skupini standardov EN 455 in preučuje možne kompromise pri izbiri rokavic v povezavi z različnimi dejavniki, ki vplivajo na rokavice, kot so fizične lastnosti, biološka združljivost, udobje in občutljivost. Preučene so tudi prednosti in pomanjkljivosti različnih alternativnih materialov za rokavice in morebitne biološke nevarnosti zaradi njihove uporabe.

General Information

• Status: Published
• Publication Date: 14-Nov-2017
• ICS: 11.140 - Hospital equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 3 - Medical gloves
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 15-Nov-2017
• Due Date: 01-Jan-2018
• Completion Date: 15-Nov-2017
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST-TP CEN/TR 16953:2018 - Medical gloves for single use - Guidance for selection

Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TP CEN/TR 16953:2018
01-januar-2018
Medicinske rokavice za enkratno uporabo - Smernice za izbiro medicinskih rokavic
za enkratno uporabo
Medical gloves for single use - Guidance for selection
Medizinische Einmalhandschuhe - Leitlinien für die Auswahl
Gants médicaux non réutilisables - Lignes directrices pour sélectionner des gants
médicaux non réutilisables
Ta slovenski standard je istoveten z: CEN/TR 16953:2017
ICS:
11.140 Oprema bolnišnic Hospital equipment
13.340.40 Varovanje dlani in rok Hand and arm protection
SIST-TP CEN/TR 16953:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST-TP CEN/TR 16953:2018

---------------------- Page: 2 ----------------------

SIST-TP CEN/TR 16953:2018


CEN/TR 16953
TECHNICAL REPORT

RAPPORT TECHNIQUE

November 2017
TECHNISCHER BERICHT
ICS 11.140
English Version

Medical gloves for single use - Guidance for selection
Gants médicaux non réutilisables - Lignes directrices Medizinische Einmalhandschuhe - Leitlinien für die
pour sélectionner des gants médicaux non réutilisables Auswahl


This Technical Report was approved by CEN on 22 October 2017. It has been drawn up by the Technical Committee CEN/TC 205.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 16953:2017 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST-TP CEN/TR 16953:2018
CEN/TR 16953:2017 (E)
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Considerations in glove selection. 8
4.1 General . 8
4.2 Cross contamination risk . 9
4.2.1 General . 9
4.2.2 Freedom from holes . 9
4.2.3 Physical properties . 10
4.2.4 Storage stability . 10
4.3 Biocompatibility . 11
4.3.1 General . 11
4.3.2 Allergenic potential . 11
4.3.3 Plasticisers. 13
4.4 Potential contaminants .
...