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PREN 13795-1 : DRAFT 2017

Current

Current

The latest, up-to-date edition.

SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 1: SURGICAL DRAPES AND GOWNS

Published date

06-27-2017

European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Performance requirements
5 Manufacturing and processing requirements
  and documentation
6 Information to be supplied with the product
Annex A (normative) - Testing
Annex B (informative) - Rationales
Annex C (informative) - Information on further characteristics
Annex D (informative) - Environmental aspects
Annex E (informative) - Guidance to users for selecting products
Annex ZA (informative) - Relationship between this European
         standard and the essential requirements of Directive
         93/42/EEC [OJ L 169] aimed to be covered
Bibliography

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

Committee
TC 205
DocumentType
Draft
PublisherName
Comite Europeen de Normalisation
Status
Current

Standards Relationship
17/30358658 DC : 0 Identical
17/30358658 DC : DRAFT JUN 2017 Identical

02/712046 DC : DRAFT OCT 2002 ISO 11810-1 - OPTICS AND OPTICAL INSTRUMENTS - LASERS AND LASER RELATED EQUIPMENT - TEST METHODS AND CLASSIFICATION FOR LASER-RESISTANCE OF SURGICAL DRAPES AND/OR PATIENT-PROTECTIVE COVERS - PRIMARY IGNITION

ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
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 11810:2015 Lasers and laser-related equipment Test method and classification for the laser resistance of surgical drapes and/or patient protective covers Primary ignition, penetration, flame spread and secondary ignition
EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
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
EN ISO 11810:2015 Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Primary ignition, penetration, flame spread and secondary ignition (ISO 11810:2015)
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 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
EN 62366 : 2008 AMD 1 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
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 9073-6:2003 Textiles - Test methods for nonwovens - Part 6: Absorption (ISO 9073-6:2000)
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)
ISO 15797:2002 Textiles Industrial washing and finishing procedures for testing of workwear
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)
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
ISO 9073-6:2000 Textiles — Test methods for nonwovens — Part 6: Absorption
EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
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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