S.R. CEN/TR 16953:2017
Current
The latest, up-to-date edition.
MEDICAL GLOVES FOR SINGLE USE - GUIDANCE FOR SELECTION
Hardcopy , PDF
English
03-12-2017
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 |
| PD CEN/TR 16953:2017 | Equivalent |
| 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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