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S.R. 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

03-12-2017

Preview

National Foreword
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

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

DocumentType
Standard Recommendation
Pages
28
PublisherName
National Standards Authority of Ireland
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 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
EN ISO 374-5:2016 Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks (ISO 374-5:2016)
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)
2016/425/EU : 2016 REGULATION (EU) 2016/425 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 9 MARCH 2016 ON PERSONAL PROTECTIVE EQUIPMENT AND REPEALING COUNCIL DIRECTIVE 89/686/EEC (TEXT WITH EEA RELEVANCE)

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