09/30190221 DC : 0

Superseded

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BS EN 13795 - 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

Superseded date

31-03-2011

Language(s)

English

Publisher

British Standards Institution

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
Bibliography

BS EN 13795

Committee	CH/205/1
DocumentType	Draft
Pages	25
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN 13795:2011+A1:2013

Standards	Relationship
PREN 13795 : DRAFT 2009	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)
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 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 9073-1:1989	Textiles — Test methods for nonwovens — Part 1: Determination of mass per unit area
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 811:1981	Textile fabrics Determination of resistance to water penetration Hydrostatic pressure test
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
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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09/30190221 DC : 0

BS EN 13795 - 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

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

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