EN 13795-2:2004+A1:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods
15-07-2009
01-03-2011
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Testing requirements
4.1 General
4.2 Atmospheres for conditioning and testing
5 Test methods
5.1 Test method for evaluation of cleanliness
- microbial
5.2 Test method for evaluation of cleanliness
- particulate matter
5.3 Test method for evaluation of linting
5.4 Test method for evaluation of resistance to
liquid penetration
5.5 Test method for evaluation of bursting strength in
dry and wet state
5.6 Test method for evaluation of tensile strength in dry
and wet state
5.7 Test methods for evaluation of liquid control
5.8 Test method for evaluation of resistance to dry microbial
penetration
5.9 Test method for evaluation of resistance to wet microbial
penetration
Annex ZA (informative) - Relationship between this European
Standard and the Essential
Requirements of EU Directive 93/42/EEC
on Medical Devices
Bibliography
This EN 13795-2 specifies test methods for evaluating characteristics of surgical drapes, gowns and clean air suits.NOTE 1Test methods are specified by referring to a standard test method and, if necessary, specifying amendments to adapt the test method for the purpose of this document.NOTE 2EN 13795-2 does not cover a test method for evaluating adhesion for fixation for the purpose of wound isolation as there is no suitable test method for adhesion to human skin available at present. For more information on adhesion for fixation for the purpose of wound isolation see EN 13795-1: 2002, Annex B.
| Committee |
CEN/TC 205
|
| DevelopmentNote |
2004 Edition Re-Issued in July 2009 & incorporates AMD 1 2009. (08/2009)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| DS EN 13795-2 : 2005 + A1 2009 | Identical |
| NS EN 13795-2 : 2004 + A1 2009 | Identical |
| I.S. EN 13795-2:2005 | Identical |
| NF EN 13795-2 : 2005 + A1 2009 | Identical |
| NBN EN 13795-2 : 2005 + A1 2009 | Identical |
| DIN EN 13795-2:2009-12 | Identical |
| GOST R EN 13795-2 : 2008 | Identical |
| GOST EN 13795-2 : 2011 | Identical |
| BS EN 13795-2 : 2004 | Identical |
| PN EN 13795-2 : 2006 + A1 2010 | Identical |
| NEN EN 13795-2 : 2004 + A1 2009 | Identical |
| BS EN 13795-2:2004+A1:2009 | Equivalent |
| UNE-EN 13795-2:2005 | Identical |
| BS EN 13795-2:2004+A1:2009 | Identical |
| UNE-EN 13795-2:2005+A1:2010 | Identical |