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EN 13795-2:2004+A1:2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods
Superseded date

03-01-2011

Published date

07-15-2009

Publisher

Comite Europeen de Normalisation

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Superseded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

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 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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