Test Methods for Textile for Surgical Drapes, Gowns and Clean Air

Suits, Used as Medical Device

Textile for medical devices is a kind of

textile including cloth made from yarn or

fibers by weaving, knitting or other types of

binding or manufacture and nonwoven

materials. But medical device contains

more parts, like single use and reusable

surgical gowns, surgical drapes, clean air

suits, surgical masks, surgical gloves,

packing materials, foot and head wear and

incision drapes.

No matter what kind of medical devices,

they are all to provide protection for

patients and clinical staff, like preventing

the transmission of infective agents

between patients and clinical staff during

the surgical and invasive procedures,

flammability and resistance to penetration

by laser radiation. Because of the different

applications, medical devices will be

classified according by their usage.

Testing standards and testing methods

are based on the applications. Taking EN

13795 as an example, the standard requires

many test methods for medical devices

which are mainly textile products for single

use and reusable surgical gowns, surgical

drapes including equipment coverings, 1

many test methods for medical devices

which are mainly textile products for single

use and reusable surgical gowns, surgical

drapes including equipment coverings,

clean air suits, etc.

There are testing methods for evaluation

and classification of cleanliness, like

microbial or particulate matter; for

determination of function and

performance, like liquid penetration

resistance, bursting strength in dry and wet

state, tensile strength in dry and wet state,

liquid control, dry microbial penetration

resistance, wet microbial penetration

resistance.

At the same time, the comfort of these

textiles for medical devices will influence or

affect the individual’s satisfaction. The

products with better comfort performance

will minimize the physiological stress during

work and provide reasonable physiological

comfort to support the physical condition

of the patient.

The thermos-physiological comfort of

garments depends on the properties as the

thermal resistance, air permeability,

devices which are mainly textile products

for single use and reusable surgical gowns,

2

garments depends on the properties as the

thermal resistance, air permeability,

water-vapour resistance and drapeability.

Tactile comfort will highly depend on the

properties of textile such as strechability,

drapeability and the surface structure of

materials and the garment weight, size, fit,

even the manufacturing technology.

There are ANSI/AMMI PB70, EN 13795.1,

EN 13795.2, EM 13795.3, ISO 9073-10, ISO

22610, ISO 22611, ISO 22612, ISO 11810

and other relative standards to standardize

the products quality and bring more safety

for patients and clinical staff all over the

world.