BS EN 13795-1:2002+A1:2009 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Part 1: General requirements for manufacturers, processors and products
This 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
standard gives general guidance 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. It is intended to prevent the
transmission of infective agents between patients and clinical staff during surgical and other invasive procedures.
Surgical masks, surgical gloves, packaging materials, foot and head wear and incision drapes are not covered by
EN 13795. Requirements for medical gloves are given in the EN 455 series of European Standards and packaging
materials are covered by the EN 868 series. Requirements for surgical masks and head coverings will be specified
in future CEN/TC 205 standards.
EN 13795 does not cover requirements for flammability of products used in laser surgery. Suitable test methods for
flammability and resistance to penetration by laser radiation, together with an appropriate classification system, are
given in EN ISO 11810. Additional essential requirements that apply to surgical clothing and drapes are covered by
other European Standards.
BS EN 13795-1:2002+A1:2009 history
1970BS EN 13795-1:2019 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment. General requirements for manufacturers, processors and products
2011BS 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
2011BS 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
2002BS EN 13795-1:2002+A1:2009 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Part 1: General requirements for manufacturers, processors and products
2002BS 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