I.S. EN 13795:2011
Withdrawn
View Superseded by
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
Hardcopy , PDF
English
01-01-2011
04-06-2020
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Withdrawn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 13795:2011 | Equivalent |
| DIN EN 13795:2011-06 | Equivalent |
| BS EN 13795:2011+A1:2013 | Equivalent |
| UNE-EN 13795:2011 | Equivalent |
| 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 9237:1995) |
| 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 13938-1:1999) |
| 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 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 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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