I.S. EN 13795-2:2005
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
Hardcopy , PDF
24-03-2011
English
01-01-2005
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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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
Describes test methods for evaluating characteristics of surgical drapes, gowns and clean air suits.
| DevelopmentNote |
2005 Edition Re-issued in September 2009 & incorporates AMD 1 2009. (09/2009)
|
| DocumentType |
Standard
|
| Pages |
12
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NF EN 13795-2 : 2005 + A1 2009 | Identical |
| DIN EN 13795-2:2009-12 | Identical |
| NBN EN 13795-2 : 2005 + A1 2009 | Identical |
| NEN EN 13795-2 : 2004 + A1 2009 | Identical |
| NS EN 13795-2 : 2004 + A1 2009 | Identical |
| SN EN 13795-2 : 2005 + A1 2009 | Identical |
| UNI EN 13795-2 : 2009 | Identical |
| UNE-EN 13795-2:2005 | Identical |
| BS EN 13795-2 : 2004 | Identical |
| EN 13795-2:2004+A1:2009 | Identical |
| 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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