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I.S. EN 13795:2011

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by
withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS, TEST METHODS, PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS
Available format(s)

Hardcopy , PDF

Withdrawn date

04-06-2020

Language(s)

English

Published date

01-01-2011

Publisher

National Standards Authority of Ireland

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 Performance requirements
5 Testing
6 Manufacturing and processing requirements
7 Information to be supplied by the manufacturer
  or processor
Annex A (informative) - Details of significant changes
        between this European Standard and the previous
        edition
Annex B (normative) - Test methods
Annex C (informative) - Prevention of infection in the
        operating room
Annex D (informative) - Information on further
        characteristics
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC on
         Medical Devices
Bibliography

Describes information to be supplied to users and third party verifiers in addition to the usual labelling of medical devices, concerning manufacturing and processing requirements.

DevelopmentNote
Supersedes I.S. EN 13795-1, I.S. EN 13795-2 and I.S. EN 13795-3. (03/2011) 2011 Edition Re-Issued in February 2013 & incorporates AMD 1 2013. (02/2013)
DocumentType
Standard
Pages
25
PublisherName
National Standards Authority of Ireland
Status
Withdrawn
SupersededBy
Supersedes

Standards Relationship
EN 13795:2011+A1:2013 Identical

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)
ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
EN 20811 : 1992 TEXTILES - DETERMINATION OF RESISTANCE TO WATER PENETRATION - HYDROSTATIC PRESSURE TEST
EN ISO 9073-11:2004 Textiles - Test methods for nonwovens - Part 11: Run-off (ISO 9073-11:2002)
ISO 9237:1995 Textiles — Determination of the permeability of fabrics to air
ISO 9073-12:2002 Textiles Test methods for nonwovens Part 12: Demand absorbency
ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
EN ISO 9237 : 1995 TEXTILES - DETERMINATION OF PERMEABILITY OF FABRICS TO AIR
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 11810-2:2007 Lasers and laser-related equipment Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers Part 2: Secondary ignition
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
EN 14065:2016 Textiles - Laundry processed textiles - Biocontamination control system
ISO 22612:2005 Clothing for protection against infectious agents Test method for resistance to dry microbial penetration
ISO 11810-1:2005 Lasers and laser-related equipment Test method and classification for the laser resistance of surgical drapes and/or patient protective covers Part 1: Primary ignition and 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 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 11092:2014 Textiles — Physiological effects — Measurement of thermal and water-vapour resistance under steady-state conditions (sweating guarded-hotplate test)
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
EN 31092:1993/A1:2012 TEXTILES - DETERMINATION OF PHYSIOLOGICAL PROPERTIES - MEASUREMENT OF THERMAL AND WATER-VAPOUR RESISTANCE UNDER STEADY-STATE CONDITIONS (SWEATING GUARDED - HOTPLATE TEST) (ISO 11092:1993/AMD 1:2012)
EN ISO 9073-10:2004 Textiles - Test methods for nonwovens - Part 10: Lint and other particles generation in the dry state (ISO 9073-10:2003)
ISO 139:2005 Textiles Standard atmospheres for conditioning and testing
EN ISO 139:2005/A1:2011 Textiles - Standard atmospheres for conditioning and testing - Amendment 1 (ISO 139:2005/AMD 1:2011)
EN ISO 11810-1:2009 Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Part 1: Primary ignition and penetration (ISO 11810-1:2005)
ISO 13938-1:1999 Textiles Bursting properties of fabrics Part 1: Hydraulic method for determination of bursting strength and bursting distension
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
EN ISO 9073-12:2004 Textiles - Test methods for nonwovens - Part 12: Demand absorbency (ISO 9073-12:2002)
EN 980:2008 Symbols for use in the labelling of medical devices
EN ISO 11810-2:2009 Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 2: Secondary ignition (ISO 11810-2:2007)
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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