EN 13795:2011 PDF

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.

EN 13795:2011 Referenced Document

EN 20811 Textiles - Determination of Resistance to Water Penetration - Hydrostatic Pressure Test
EN 29073-3 Textiles - Test Methods for Nonwovens - Part 3: Determination of Tensile Strength and Elongation
EN ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)
EN ISO 139 Textiles - Standard atmospheres for conditioning and testing - Amendment 1 (ISO 139:2005/AMD 1:2011)*， 2011-07-01 Update
EN ISO 13938-1 Textiles - Bursting properties of fabrics - Part 1: Hydraulic method for determination of bursting strength and bursting distension (ISO 13938-1:2019)*， 2019-12-04 Update
EN ISO 22610 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
EN ISO 22612 Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration (ISO 22612:2005)

2013 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 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 (Incorporates A