STANDARD TEST METHODS

FOR MEDICAL TEXTILES

S.KADIRVEL
SITRA

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FACE MASK

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 FACE MASK

A surgical face mask is an important

medical device used to protect both
surgical patients and operating room
personnel from the transfer of
microorganisms, body fluids and
particulate material.

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IMPORTANT TEST METHODS TO EVALUATE
FACE MASK PRODUCT CHARACTERISTICS

¾Air permeability

¾Bacterial filtration efficiency %

¾Splash resistance

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 Bacterial filtration efficiency %
-ASTM F 2101
This test method measures the percent efficiency
at which the face mask filters bacteria passing
through the mask. The maximum filtration
efficiency that can be determined by this method is
99.9%

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 SPLASH RESISTANCE MMHG-ASTM F1862

This test method is used to evaluate the

resistance of medical face masks to
penetration by the impact of a small volume
(2ml) of a high velocity stream of synthetic
blood. Medical face mask pass/fail
determinations are based on visual detection
of synthetic blood penetration

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SURGICAL GOWN

7
Surgical gowns are worn by the doctors
and nurses in the operating theater to
address dual function of preventing
transfer of microorganism and body
fluids from the operating staff to the
patient and also from patient to staff

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 BASIC REQUIREMENTS NEEDED FOR
SURGICAL GOWN
¾ Resist the penetration of liquids and
microorganisms
¾ Breathable
¾ Flexible
¾ Inexpensive

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DIFFERENT TEXTILE STRUCTURES USED
IN SURGICAL GOWN

¾Single use type, made up by non-woven

techniques

¾Reusable category and normally

developed through weaving

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 Major Organizations Have Published
Guideline For Healthcare Workers
• Centers for Disease Control and prevention (CDC)
• Association of pre-operative Registered Nurses
(AORN)
• Occupational Safety and Health Administration
(OSHA)
• Operating Room Nurses Association of Canada
(ORNAC)
• Association for the Advancement of Medical
Instrumentation (AAMI)

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 AAMI CLASSIFICATION

There are four tests that must be performed

in order to evaluate the performance of
surgical gown.
1. Spray Impact Penetration Test
2. Hydrostatic Head Test
3. Resistance to synthetic blood
4. Viral penetration resistance

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 AAMI CLASSIFICATION SYSTEM
• There are four levels of barrier performance, level 4 being the highest
protection available

Level Test Result

Least
AATCC 42
Protective
1 < 4.5 g
Water Impact (WI)

AATCC 42, WI < 1.0 g

2
AATCC 127 Hydro Head (HH) > 20 cm

AATCC 42, WI < 1.0 g

3
AATCC 127, HH > 50 cm
Most
Protective ASTM F1671, Gowns Pass
4
ASTM F1670, Drapes Pass

• AAMI - Association for the Advancement of Medical Instrumentation

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SPRAY IMPACT PENETRATION TEST:
AATCC 42

A volume of synthetic blood is allowed to

spray against the taut surface of a test
specimen backed by a weighed blotter. The
blotter is then reweighed to determine water
penetration and the specimen is classified
accordingly.

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WATER RESISTANCE: HYDROSTATIC
PRESSURE TEST

One surface of the test specimen is

subjected to a hydrostatic pressure,
increasing at constant rate, until three
points of leakage on its surface. The
water may be applied from above or
below the test specimen.

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 Resistance to synthetic blood-ASTM F 1670

A specimen is subjected to body fluid stimulant

(synthetic blood) for a specified time and pressure.
Visual observation is made to determine when
penetration occurs. Any evidence of synthetic blood
penetration constitutes failure. Results are reported
as pass or fail

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 RESISTANCE TO PENETRATION BY
BLOOD-BORNE PATHOGENS -
ASTM F 1671

• This test method is used to measure the resistance

of materials used in protective clothing to
penetration by blood borne pathogens using a
surrogate microbe under conditions of continuous
liquid contact Protective clothing material
pass/fail determinations are based on detection of
viral penetration.

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 OTHER TEST METHODS
EVALUATE THE SURGICAL GOWN

¾ Water vapour transmission rate

¾ Tensile Strength
¾ Air Permeability
¾ Stiffness
¾ Flammability
¾ Bursting strength
¾ Thermal resistance

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 INTERNATIONAL SPECIFICATIONS
FOR SURGICAL GOWN
¾ Specification for surgical gown-ASTM F 2407
This specification establishes requirements for the
performance, documentation, and labeling for
surgical gowns used in healthcare facilities

¾ European EN 13795 aims to establish

requirements for surgical gown, surgical drape and
clean air suits used as medical devices for patients,
clinical staff and equipment

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SURGICAL DRAPE

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 TEST METHODS

¾ Drape
¾ Air permeability
¾ Weight per unit area
¾ Breaking strength and elongation of textile fabrics
¾ Flammability
¾ Anti bacterial activity assessment (Qualitative)
¾ Antibacterial activity assessment (Quantitative)
¾ Thermal resistance
¾ Linting test
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HOSPITAL BED LINEN

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 TEST METHODS TO EVALUATE THE
CHARACTERISICS OF BED LINEN

¾Weight/square metre
¾Tensile strength
¾Tear strength
¾Antibacterial activity assessment
(Qualitative)
¾Antibacterial activity assessment
(Quantitative)

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BABY DIAPER

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¾ Diaper is used for wrapping the newly born
or young children, who have not developed
the fixed routine for making water or latrine.

¾ Diapers retain the liquid for about two hours

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¾ Diapers can play an important role in
contamination prevention and the reduction of
infection

¾ Disposable diapers are more effective in

urine/feces containment than cloth

¾ Increased contamination of surfaces in day care

settings has been linked to infectious diarrhea
outbreaks

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 DIAPER CONSTRUCTION

¾ Cover stock / top sheet layer (non-woven

material)

¾ Absorbent core (Cellulose fluff pulp + Super

absorbent polymer)

¾ Back sheet: Polyethylene film structure or a

film / non-woven composite
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 IMPORTANT PROPERTIES
REQUIRED FOR THE BABY DIAPER

¾ Soft
¾ High absorbency
¾ Protection against leakage
¾ Should not re-wet
¾ Comfortable

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 TEST METHODS TO EVALUATE
THE FUNCTION OF BABY DIAPER
¾ Speed of Absorption
¾ Re-wet
¾ Absorbent Capacity
¾ Absorbent Retention
¾ Fit and Comfort

First three performances are very

important
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LIQUID – STRIKE THROUGH TIME
(SIMULATED URINE)

This test method measures the strike

through time (i.e.) the time taken for a
known volume simulated urine applied
to the surface of a test piece of
non-woven cover stock, which is in
contact with an underlying absorbent
pad, to pass through non-woven.
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 DIAPER RE-WET

The purpose of the test is to examine

the ability of diaper cover stock to resist
the transport back onto the skin of a
liquid which has already penetrated the
cover stock.

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INCONTINENCE PRODUCT

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INCONTINENCE PRODUCT TESTING

¾ Volume of leaked liquid

¾ Absorption rate
¾ Wicking rate
¾ Wettability
¾ Permeability

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SANITARY NAPKIN

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 TEST METHODS
¾ Absorbency
The sanitary napkins shall absorb 30
ml of coloured water or oxalated
Sheep or goat blood or test fluid when
lowed onto the centre of the napkin
(at the rate of 15 ml per minute) and it
shall not stain through/leak through
at the bottom sides of the sanitary
napkin
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 TEST METHODS
¾ pH Value
The sanitary napkin shall be free from
acids and alkali and the pH of the
absorbent material shall be 6 to 8.5

¾ Disposability
A disposable sanitary napkin with the
covering removed, shall be immersed in
15 litres of water and stirred. The pad
shall disintegrate in the water in not more
than 5 minutes SITRA 36
GAUZE BANDAGE

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 Test methods to evaluate the characteristics
of Gauze bandage
¾ Yarn count (Tex)
¾ Threads/10cm
¾ Colouring matter
¾ Surface active substances
¾ Sulphated ash
¾ Ether soluble substances
¾ Water soluble substances
¾ Loss on drying
¾ Foreign matter
¾ Viable micro organism prior to sterility (cfu/gram)
¾ pH
¾ Absorbency(second)
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PLASTER OF PARIS BANDAGE

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TEST METHODS TO EVALUATE THE
CHARACTERISTICS OF PLASTER OF
PARIS BANDAGE
¾ Threads per unit length
¾ Weight of the fabric (GSM)
¾ % Calcium sulphate
¾ Tensile strength, kg/cm2
¾ Compressive strength kg/cm2
¾ Setting time, minutes
¾ Alkalinity

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CREPE BANDAGE

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 TEST METHODS TO EVALUATE THE
CHARACTERISTICS OF CREPE BANDAGE

¾ Yarn count
¾ Warp yarn twist
¾ Threads/10cm
¾ Stretchability
¾ Breaking load
¾ pH

SITRA 42
NON-WOVEN GAUZE BANDAGE

Non-woven gauze is of mesh structure

(similar to woven cloth) made from
viscose rayon, polyester blend fabric
with minimum 65% viscose content.

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TEST METHODS
¾ Weight (GSM)
¾ Length and width
¾ Fluorescence
¾ Sterility
¾ Foreign matter
¾ Absorbency (second)

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SUTURES

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Tests should be carried out for sutures

¾ Diameter
¾ Tensile strength
¾ Bending stiffness
¾ Surface roughness
¾ Knot pull strength
¾ Knot security

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CIRCULAR KNITTED BANDAGES

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 THE FOLLOWING TESTS SHALL BE
CONDUCTED FOR CIRCULAR KNITTED
BANDAGES
¾ Thickness
¾ Air permeability
¾ Weight per unit area
¾ Breaking strength and elongation of textile fabrics
¾ Skin irritation
¾ Anti bacterial activity assessment (Qualitative)
¾ Antibacterial activity assessment (Quantitative)
¾ Thermal resistance

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COMBINED WOUND DRESSINGS

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¾ Wound contact layer
¾ Middle absorbing layer
¾ Base material

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 THE FOLLOWING TESTS SHALL BE
CONDUCTED FOR COMBINED WOUND
DRESSINGS
¾ Skin irritation test
¾ Air permeability
¾ Weight per unit area
¾ Breaking strength and elongation of textile fabrics
¾ Absorbency
¾ Anti bacterial activity assessment (Qualitative)
¾ Antibacterial activity assessment (Quantitative)
¾ Thermal resistance

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 Elastic adhesive bandage

It consists of a woven fabric, elastic in warp

direction and coated with the adhesive mass
containing zinc oxide. The adhesive mass
may be porous or permeable to air and water
vapour

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 Test methods
¾ Threads per 10cm
¾ Weight of the fabric (GSM)
¾ Weight of adhesive mass
¾ Zinc oxide content in adhesive mass
¾ Adhesive strength g/2.5cm
¾ Moisture vapour permeability
¾ Regain length

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 CELLULOSE WADDING

Cellulose wadding consists of compressed

sheets of felted fibres, consisting almost
entirely of cellulose. The fibres are bleached
good white.

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 TEST METHODS

¾ Weight per unit area (GSM)

¾ Sulphated ash
¾ Loss on drying
¾ Absorbency(second)
¾ Chloroform soluble substances

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VASCULAR GRAFT

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Arteries are the blood vessels, which
carry oxygenated blood throughout the
body. These arteries sometimes get
damaged and fail to do the work
properly. Artificial grafts are developed
to act as blood vessels and they are
called as vascular grafts.

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TEST METHODS TO EVALUATE
VASCULAR GRAFT

¾ Biocompatibility
¾ Porosity
¾ Bursting strength
¾ Tensile strength
¾ Water permeability

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 IMPLANTABLE TEST METHODS

Most of the implantable products will be tested

for the Biocompatibility test

¾ Biocompatibility - Reaction of textile with blood

and tissue of the body

¾ This test & skin irritation test can be conducted

at Sree Chitra Tirunal Institute for Medical
Sciences and Technology (SCTIMST),
Trivandrum. SITRA 59
 ROLE OF SITRA TESTING SERVICES
FOR MEDITECH PRODUCT

¾Preparation of proposed draft standards

for different Meditech product

¾Facilities for testing and evaluation of

products of medical textiles

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 PROPOSED STANDARD TEST
METHODS FOR MEDITECH
PRODUCT DEVELOPED BY SITRA

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¾ Gown
¾ Surgical drapes
¾ Face mask
¾ Bed linen
¾ Baby diaper
¾ Incontinence products
¾ X-ray detectable gauze
¾ Gauze bandage

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¾ Plaster of Paris bandage
¾ Elastic adhesive bandage
¾ Cellulose wadding
¾ Impermeable plastic wound dressings
¾ Crepe bandages
¾ Sutures
¾ Absorbent cotton

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¾ Non-woven gauze bandage
¾ Vapour- permeable waterproof plastic
wound dressings
¾ Vascular craft
¾ Perforated film dressings
¾ Knitted viscose primary dressings

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 FEATURES OF NEW TESTING
FACILITIES AVAILABLE IN SITRA
MEDITECH LAB

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LISTER AC & WETBACK

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SITRA 67
 Test piece is placed on filter papers

Simulated urine is discharged on to a test piece

through strike plate

Electrical conductive liquid starts the timer by

means of electrodes

After the liquid has penetrated into the absorbent

pad the electrical circuit is interrupted and the
timer is automatically stopped

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WETBACK

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 WETBACK
After test piece has been tested with liquid strike through test
15 ml of simulated urine has to be added

The dead weight is lowered and put on to the test piece

Filter papers are weighed & placed it onto the sample

The weight once again lowered and put onto the sample

Filter paper reweighed

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SWEATING GUARDED HOT PLATE

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¾ THERMAL RESISTANCE, RCT
Temperature difference between the two faces of a
material divided by the resultant heat flux per unit
area in the direction of the gradient.

¾ WATER-VAPOR RESISTANCE, RET

Water-vapor pressure difference between the two
faces of a material divided by the resultant
evaporative heat flux per unit area in the direction
of the gradient

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BACTRIAL FILTERATION
EFFICIENCY TESTER

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¾This instrument measures the percent
efficiency at which the face mask filters
bacteria passing through the mask.

¾The maximum filtration efficiency (99.9%)

can be determined.

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Bacteria aerosol is passed into the 6 agar
plates without specimen

The control samples collected & placed in

incubator

Bacteria aerosol is passed with specimen

Total the counts from each of the six agar

plate
Bacterial filtration efficiency is calculated
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Hydro head tester

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 Specimen is clamped in testing head

Hydrostatic pressure is applied on bottom layer of

the specimen

Observe the top layer of the specimen

Stop the test when observe 3 drop

Record the average hydrostatic pressure

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3 DROP IMAGE

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INSTRON 6021

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¾ Tensile strength and elongation
¾ Peel strength
¾ Stress relaxation
¾ Creep
¾ Cohesive force
¾ Knot strength

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 Centre of Excellence
¾ SITRA has been identified as Centre of
Excellence for Medical and Hygiene
Textiles by The Ministry of Textiles,
Government of India.

¾ For more detail please visit our websites:

www.sitra.org.in
www.sitrameditech.org.in

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