I.S. EN 13795:2011
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
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
06-04-2020
English
01-01-2011
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.
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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Withdrawn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 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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