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I.S. EN 13795-2:2005

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

Available format(s)

Hardcopy , PDF

Superseded date

03-24-2011

Language(s)

English

Published date

01-01-2005

Preview

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.

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Superseded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

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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