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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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Published date

15-07-2009

Superseded date

01-03-2011

Superseded by

EN 13795:2011+A1:2013

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Summarise this standard

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Superseded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

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