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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
01-03-2011
15-07-2009
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Superseded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 |
| SN EN 13795-2 : 2005 + A1 2009 | Identical |
| UNI EN 13795-2 : 2009 | Identical |
| BS EN 13795-2 : 2004 | Identical |
| PN EN 13795-2 : 2006 + A1 2010 | Identical |
| UNE-EN 13795-2:2005 | Identical |
| NEN EN 13795-2 : 2004 + A1 2009 | Identical |
| BS EN 13795-2:2004+A1:2009 | Identical |
| UNE-EN 13795-2:2005+A1:2010 | Identical |
| I.S. EN 13795-3:2006 | SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 3: PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS |
| PREN 13795-3 : DRAFT 2004 | SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 3: PERFORMANCE REQUIREMENTS |
| 07/30166924 DC : DRAFT AUG 2007 | BS EN 868-2 - PACKAGING MATERIALS FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS |
| DIN EN ISO 22610:2015-12 (Draft) | SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - TEST METHOD TO DETERMINE THE RESISTANCE TO WET BACTERIAL PENETRATION |
| PREN 868-2 : DRAFT 2015 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS |
| BS EN ISO 22610:2006 | Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment. Test method to determine the resistance to wet bacterial penetration |
| DIN EN ISO 22610:2006-10 | Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration (ISO 22610:2006) |
| EN ISO 22610:2006 | Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration (ISO 22610:2006) |
| UNI EN 13795-3 : 2009 | SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 3: PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS |
| 15/30325855 DC : 0 | BS EN 868-2 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS |
| 04/30038440 DC : DRAFT NOV 2004 | BS EN 13795-3 - SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 3: PERFORMANCE REQUIREMENTS |
| ISO 22610:2006 | Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment Test method to determine the resistance to wet bacterial penetration |
| EN 13795-3:2006+A1:2009 | Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels |
| BS EN 13795-3 : 2006 | SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 3: PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS |
| DIN EN 13795-3:2009-12 | SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 3: PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS |
| EN 13795-1:2002+A1:2009 | Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products |
| EN 20139 : 1992 | TEXTILES - STANDARD ATMOSPHERES FOR CONDITIONING AND TESTING |
| EN 20811:1992 | Textiles - Determination of resistance to water penetration - Hydrostatic pressure test |
| ISO 9073-12:2002 | Textiles — Test methods for nonwovens — Part 12: Demand absorbency |
| EN 1174-3 : 1996 | STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - GUIDE TO THE METHODS FOR VALIDATION OF MICROBIOLOGICAL TECHNIQUES |
| EN 1174-1 : 1996 | STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - REQUIREMENTS |
| EN 1174-2 : 1996 | STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - GUIDANCE |
| ISO 22612:2005 | Clothing for protection against infectious agents Test method for resistance to dry microbial penetration |
| EN 29073-3:1992 | Textiles - Test methods for nonwovens - Part 3: Determination of tensile strength and elongation |
| EN ISO 13938-1:1999 | Textiles - Bursting properties of fabrics - Part 1: Hydraulic method for determination of bursting strength and bursting distension (ISO 13938-1:1999) |
| ISO 9073-11:2002 | Textiles — Test methods for nonwovens — Part 11: Run-off |
| ISO 9073-10:2003 | Textiles — Test methods for nonwovens — Part 10: Lint and other particles generation in the dry state |
| ISO 139:2005 | Textiles — Standard atmospheres for conditioning and testing |
| ISO 13938-1:1999 | Textiles Bursting properties of fabrics Part 1: Hydraulic method for determination of bursting strength and bursting distension |
| EN ISO 22612:2005 | Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration (ISO 22612:2005) |
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