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  • BSI
    BS EN 13795:2011+A1:2013 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
    Edition: 2013
    $435.35
    / user per year

Description of BS EN 13795:2011+A1:2013 2013

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.

Standard NumberBS EN 13795:2011+A1:2013
TitleSurgical 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
StatusWithdrawn
Publication Date2013-04-30
Withdrawn Date2020-02-04
ReplacesBS EN 13795-2:2004+A1:2009, BS EN 13795-3:2006+A1:2009, BS EN 13795-1:2002+A1:2009
Identical National Standard OfEN 13795:2011+A1:2013
AmendsBS EN 13795:2011
DescriptorsHospital equipment, Medical equipment, Water-resistance tests, Burst tests, Instructions for use, Re-usable, Decontamination, Surgical equipment, Microbiological-resistance tests, Testing conditions, Performance testing, Biological hazards, Protective clothing, Tensile testing, Performance, Grades (quality), Disposable, Hygiene, Gowns (protective), Biological analysis and testing
ICS11.140 Hospital equipment
CommitteeCH/205
ISBN978 0 580 82249 0
PublisherBSI
Pages26

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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