BS EN 13795:2011+A1:2013
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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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
04-02-2020
English
30-04-2013
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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
This European Standard specifies information to be supplied to users and third party verifiers in addition to the usual labelling of medical devices (see EN 980 and EN 1041), concerning manufacturing and processing requirements.
| Committee |
CH/205
|
| DevelopmentNote |
Supersedes BS EN 13795-1, BS EN 13795-2, BS EN 13795-3 & 09/30190221 DC. (04/2011) 2011 Edition Re-Issued in April 2013 & incorporates AMD 1 2013. (04/2013)
|
| DocumentType |
Standard
|
| Pages |
26
|
| ProductNote |
CSV Version of this standard is now available. This standard also refers to EN ISO 11737-1:2006, EN ISO 11607-1, EN ISO 11607-2, EN ISO 13485
|
| PublisherName |
British Standards Institution
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
This European Standard specifies information to be supplied to users and third party verifiers in addition to the usual labelling of medical devices (see EN 980 and EN 1041), concerning manufacturing and processing requirements. This European Standard gives information on the characteristics of single-use and reusable surgical gowns, surgical drapes and clean air suits used as medical devices for patients, clinical staff and equipment, intended to prevent the transmission of infective agents between patients and clinical staff during surgical and other invasive procedures. This European Standard specifies test methods for evaluating the identified characteristics of surgical drapes, gowns and clean air suits and sets performance requirements for these products. EN 13795 does not cover requirements for flammability of products. Suitable test methods for flammability and resistance to penetration by laser radiation, together with an appropriate classification system, are given in EN ISO 11810-1 and EN ISO 11810-2. Additional essential requirements that apply to surgical clothing and drapes are covered by other European Standards.
| 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 |
| 89/686/EEC : 1989 AMD 5 2012 | COUNCIL DIRECTIVE OF 21 DECEMBER 1989 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO PERSONAL PROTECTIVE EQUIPMENT |
| 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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