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PD CEN/TR 16953:2017

Current
Current

The latest, up-to-date edition.

Medical gloves for single use. Guidance for selection
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

13-12-2017

Publisher

British Standards Institution

European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Considerations in glove selection
5 Raw materials
6 Glove disinfection
7 Labelling
Annex A (informative) - Glove materials and their use
Annex B (informative) - Additional information
Annex C (informative) - CE-Marking
Bibliography

Defines information for those choosing or using sterile and non-sterile gloves for medical applications based on a risk assessment.

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.

Committee
CH/205/3
DocumentType
Standard
Pages
28
PublisherName
British Standards Institution
Status
Current

Standards Relationship
CEN/TR 16953:2017 Identical

EN ISO 374-1:2016 Protective gloves against dangerous chemicals and micro-organisms - Part 1: Terminology and performance requirements for chemical risks (ISO 374-1:2016)
EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
89/686/EEC : 1989 AMD 5 2012 COUNCIL DIRECTIVE OF 21 DECEMBER 1989 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO PERSONAL PROTECTIVE EQUIPMENT
2007/47/EC : 2007 COR 1 2015 DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE)
EN 16523-1:2015 Determination of material resistance to permeation by chemicals - Part 1: Permeation by liquid chemical under conditions of continuous contact
EN 388 : 1994 PROTECTIVE GLOVES AGAINST MECHANICAL RISKS
EN ISO 3745:2012/A1:2017 ACOUSTICS - DETERMINATION OF SOUND POWER LEVELS AND SOUND ENERGY LEVELS OF NOISE SOURCES USING SOUND PRESSURE - PRECISION METHODS FOR ANECHOIC ROOMS AND HEMI-ANECHOIC ROOMS (ISO 3745:2012/AMD 1:2017)
EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
ISO 1382:2012 Rubber Vocabulary
ISO 374-1:2016 Protective gloves against dangerous chemicals and micro-organisms Part 1: Terminology and performance requirements for chemical risks
EN 420:2003+A1:2009 Protective gloves - General requirements and test methods
ISO 472:2013 Plastics Vocabulary
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
EN 374-2:2014 Protective gloves against dangerous chemicals and micro-organisms - Part 2: Determination of resistance to penetration
ISO 374-5:2016 Protective gloves against dangerous chemicals and micro-organisms Part 5: Terminology and performance requirements for micro-organisms risks
EN 923 : 2015 COR 2016 ADHESIVES - TERMS AND DEFINITIONS
EN 374-4:2013 Protective gloves against chemicals and micro-organisms - Part 4: Determination of resistance to degradation by chemicals
EN ISO 472:2013 Plastics - Vocabulary (ISO 472:2013)

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Hardcopy - English
PDF - English
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