BS EN 13795:2011
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

Standard No.

BS EN 13795:2011

Release Date

2011

Published By

British Standards Institution (BSI)

Status

Be replaced 2011-03

Replace By

BS EN 13795:2011+A1:2013

Latest

BS EN 13795:2011+A1:2013

Scope

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.

BS EN 13795:2011 history

• 2011 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
• 2011 BS EN 13795:2011 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
• 2004 BS EN 13795-2:2004+A1:2009 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment — Part 2: Test methods
• 2004 BS EN 13795-2:2004 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Test methods
• 2002 BS EN 13795-1:2002 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - General requirements for manufacturers, processors and products