ASTM F2528-06(2023)
(Test Method)Standard Test Methods for Enteral Feeding Devices with a Retention Balloon
Standard Test Methods for Enteral Feeding Devices with a Retention Balloon
ABSTRACT
These test methods cover the establishment of performance requirements for the utilization of a single-use, enteral feeding device with a retention balloon, used by medical professionals for providing a means of nutrition and/or administration of medication to patients by means of natural orifice (nasal, oral, transluminal) and or a surgically created stoma. The product is manufactured in various sizes and materials such as silicone, urethane, and various polymers (as well as combinations of these) and is provided nonsterile for sterilization and sterile for single use only. The following test methods are: Flow rate through feeding lumen test method which covers the determination of flow rates through the drainage lumen of the enteral feeding device with retention balloon, balloon burst volume test method which covers the determination of balloon integrity of enteral feeding devices with retention balloon, balloon volume maintenance test method which is applicable enteral feeding devices with retention balloon to test the integrity of the inflation system to maintain balloon volume, balloon concentricity test method which is applicable enteral feeding devices with retention balloon to test the concentricy of the balloon, balloon size and shaft size test method which evaluates the retention balloon shaft size, balloon integrity test method which evaluates the integrtity of the retention balloon of the enteral feeding device, and balloon integrity in simulated gastric fluid test method which assesses the ability of the retention balloon to withstand gastric acidity levels without rupture, therefore, maintaining its functional purpose of retention.
SCOPE
1.1 These test methods cover the establishment of performance requirements for the utilization of a single-use, enteral feeding device with a retention balloon, used by medical professionals for providing a means of nutrition and/or administration of medication to patients by means of natural orifice (nasal, oral, transluminal) and or a surgically created stoma. The product is manufactured in various sizes and materials such as silicone, urethane, and various polymers (as well as combinations of these) and is provided nonsterile for sterilization and sterile for single use only. Rationale for these test methods can be found in Appendix X1.
1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
General Information
Relations
Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F2528 − 06 (Reapproved 2023)
Standard Test Methods for
Enteral Feeding Devices with a Retention Balloon
This standard is issued under the fixed designation F2528; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 3.1.1 balloon integrity (resistance to rupture), n—volume of
liquid that corresponds with balloon failure, or bursting.
1.1 These test methods cover the establishment of perfor-
3.1.2 distal, n—refers to the balloon end of the enteral
mance requirements for the utilization of a single-use, enteral
feeding device
feeding device with a retention balloon, used by medical
professionals for providing a means of nutrition and/or admin-
3.1.3 enteral feeding device with retention balloon, n—a
istration of medication to patients by means of natural orifice
two-way medical device intended to provide a means of
(nasal, oral, transluminal) and or a surgically created stoma.
nutrition or administration of medication, or both, to patients
The product is manufactured in various sizes and materials
by means of natural orifice (nasal, oral, transluminal) or a
such as silicone, urethane, and various polymers (as well as
surgically created stoma, or both, consisting of a drainage
combinations of these) and is provided nonsterile for steriliza-
lumen and inflation lumen (see Fig. 1). Common balloon
3 3 3
tion and sterile for single use only. Rationale for these test
inflation sizes are 5 cm , 15 cm , and 20 cm .
methods can be found in Appendix X1.
3.1.4 French size (Fr), n—a scale used for denoting the size
1.2 This standard does not purport to address all of the
of catheters and other tubular instruments. The French size
safety concerns, if any, associated with its use. It is the
value is three times the outer diameter of the tube as measured
responsibility of the user of this standard to establish appro-
in millimetres. For example, a diameter of 18 Fr indicates a
priate safety, health, and environmental practices and deter-
diameter of 6 mm.
mine the applicability of regulatory limitations prior to use.
3.1.5 inflation volume, n—volume of liquid used to inflate
1.3 This international standard was developed in accor-
the retention balloon of the enteral feeding device for proposed
dance with internationally recognized principles on standard-
testing in this standard.
ization established in the Decision on Principles for the
3.1.6 rated volume, n—stated volume of inflation of the
Development of International Standards, Guides and Recom-
retention balloon of the enteral feeding device in the manufac-
mendations issued by the World Trade Organization Technical
turer’s labeling and instructions for use.
Barriers to Trade (TBT) Committee.
3.1.7 simulated gastric fluid, n—a solution consisting of
2. Referenced Documents
hydrochloric acid, salt, and pepsin with a pH of approximately
1.2, per USP standard recipe.
2.1 ASTM Standards:
F623 Performance Specification for Foley Catheter
3.1.8 sterility, n—the state of being free from viable micro-
2.2 Other Standard:
organisms.
Simulated Gastric Fluid, USP Official Compendia of Stan-
dards
4. Specimen Preparation
3. Terminology 4.1 All test specimens for test methods listed below shall
consist of the manufacturer’s new, finished, untested, unsteril-
3.1 Definitions:
ized product. At the minimum, statistically valid samples of the
smallest and the largest diameter of enteral feeding devices
These test methods are under the jurisdiction of ASTM Committee F04 on
shall be tested.
Medical and Surgical Materials and Devices and are the direct responsibility of
Subcommittee F04.35 on GI Applications.
Current edition approved July 1, 2023. Published July 2023. Originally approved
5. Test Methods
in 2006. Last previous edition approved in 2014 as F2528 – 06 (2014). DOI:
10.1520/F2528-06R23.
PROCEDURE A: FLOW RATE THROUGH FEEDING
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
LUMEN
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
5.1 Scope—This test method covers the determination of
the ASTM website.
3 flow rates through the drainage lumen of the enteral feeding
USP Official Compendia of Standards, available from U.S. Pharmacopeia
(USP), 12601 Twinbrook Pkwy., Rockville, MD 20852. device with retention balloon.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2528 − 06 (2023)
PROCEDURE B: BALLOON BURST VOLUME
5.9 Scope—This test method covers the determination of
balloon integrity of enteral feeding devices with retention
balloon.
5.10 Summary of Test Method—The enteral feeding device
with retention balloon is submerged in a small container filled
with water. The balloon is then inflated with water until
FIG. 1 Enteral Feeding Device with Retention Balloon
rupture, which enables the volume at which the balloon bursts
to be observed.
5.11 Significance and Use—The balloon burst volume is
measured to quantify the resistance to rupture of the enteral
5.2 Summary of Test Method—The apparatus is set up as
feeding device with retention balloon member.
shown in Fig. 2. The flow rate is adjusted through the water
inlet to a rate sufficient to maintain flow through the overflow
5.12 Apparatus—The testing apparatus is set up as shown in
outlet while each enteral feeding device is tested. A head Fig. 3.
pressure of 20 6 1.0 cm of water (196 6 10 kPa) above the
5.12.1 System Reservoir.
tank bottom shall be maintained throughout the test to approxi-
5.12.2 Syringe.
mate actual physiological conditions. The overflow outlet
5.12.3 Water.
should not be covered by water.
5.13 Hazards—Water should be emptied from system res-
5.3 Significance and Use—The flow rate is measured in ervoir through purge valve when fill marked is reached.
reverse flow for ease in testing, since differences in the flow
5.14 Procedure:
rate as a result of flow direction are theoretically insignificant.
5.14.1 Test at 23 6 4 °C (73.4 6 7 °F).
5.4 Apparatus: 5.14.2 Insert uninflated enteral feeding device into test
orifice in system reservoir per Fig. 3.
5.4.1 Water Reservoir, capable of maintaining 20 6 1.0 cm
5.14.3 Close orifice so that it is positioned proximal to the
(7.9 6 0.4 in.) of water (196 6 10 kPa) above the tip of the
enteral feeding device connection throughout the test as shown enteral feeding device with retention balloon member. The
device is not to be immersed in water within the reservoir per
in Fig. 2. (See Performance Specification F623.)
Fig. 3.
5.4.2 Graduated Cylinder, calibrated for suitable measure-
5.14.4 Fill syringe with amount of water greater than that
ment of the effluent.
listed in Table 1 for the desired French size. Attach tip of
5.4.3 Syringe, with appropriate tip for inflation of enteral
syringe to enteral feeding device inflation valve.
feeding device balloon.
5.14.5 Inflate retention balloon at 1 cm /s with water until
5.5 Hazards:
balloon bursts. Record amount of water injected into balloon at
5.5.1 Overflow should not be covered. Head pressure must
time of burst.
be kept constant; water should always be exiting through the
5.15 Interpretation of Results—Burst volumes for enteral
overflow outlet.
feeding devices tested must meet or exceed those listed in
5.5.2 Establish equilibrium before testing.
Table 1.
5.5.3 Flow rates through all fittings must exceed that of the
5.16 Precision and Bias—To be determined within five
enteral feeding device being tested.
years.
5.6 Procedure:
5.6.1 Test at 23 6 4 °C (73.4 6 7 °F).
PROCEDURE C: BALLOON VOLUME
5.6.2 Inflate the retention balloon of the test specimen with MAINTENANCE
water to labeled volume.
5.17 Scope—This test method is applicable for enteral
5.6.3 Connect the enteral feeding device to enteral feeding
feeding devices with retention balloon to test the integrity of
device connector and open the stopcock. The tip of the enteral
the inflation system to maintain balloon volume.
feeding device connection at the junction of enteral feeding
5.18 Summary of Test Method—The balloon retention de-
device on-off valve should be level with the bottom of the tank
vice of the enteral feeding device is inflated with a test liquid.
61 cm and it should deliver fluid at 20 6 1 cm (196 6 10 kPa)
This test liquid contains a colorant which enables a leak of this
head pressure at that junction.
fluid to be observed. If no leak is observed, the integrity of the
5.6.4 Establish flow equilibrium before taking test measure-
inflation system is upheld, therefore maintaining the balloon
ments.
volume.
5.6.5 Record the amount of fluid through the device feeding
5.19 Significance and Use—This test method establishes a
lumen in 30 s.
standard test method for determining the functional integrity of
5.7 Interpretation of Results—Flow rates for enteral feeding
the inflation system of the enteral feeding device with retention
devices tested must meet or exceed 9 cm /min.
balloon by observing the consistancy of volume of the balloon
5.8 Precision and Bias—To be determined within five years. after it is filled with test liquid. Additionally, since it is the
F2528 − 06 (2023)
FIG. 2 Flow Rate Apparatus
TABLE 1 Minimum Burst Volumes
Rated Balloon Inflation Volume Minimum Burst Volume
3 3
(cm ) (cm )
5 10
10 20
15 30
20 40
All others > 20 cm 2× rated volume
5.20.3 Background Material, suitable for detection of any
leakage (for example, paper towel).
5.21 Hazards—Ensure that the syringe is properly seated in
the valve.
5.22 Procedure:
5.22.1 Test at 23 6 4 °C (73.4 6 7 °F).
5.22.2 Inflate the balloon with the methylene blue solution
to the labeled volume.
FIG. 3 Balloon Burst Apparatus
5.22.3 Place on a surface suitable for detection of color
leakage for a 15 min period. Cover or protect the enteral
feeding devices from light or ozone for the duration of the test.
function of the inflated balloon to retain the feeding device in
position, the balloon must inflate, retain inflation volume, and 5.23 Interpretation Results:
release that volume when required. 5.23.1 Failure to inflate is a failure of the liquid from the
filling device (syringe) to enter the retention balloon.
5.20 Apparatus:
5.23.2 Failure of retention is a discoloration of or leakage on
5.20.1 Syringe.
the clean surface between the enteral feeding device.
5.20.2 Methylene Blue Crystal Solution or Equivalent—
Prepare 1 g of methylene crystals and dilute in 2000 cm of 5.24 Precision and Bias—To be determined within five
water, to be detectable in the described retention test. years.
F2528 − 06 (2023)
TABLE 2 Concentricity Ratios
Rated Balloon Inflation Volume Maximum Concentricity
(cm ) Ratio
5 2:1
10 2:1
15 2:1
20 2:1
All others > 20 cm 2:1
5.36 Apparatus—The testing apparatus is as shown in Fig.
FIG. 4 Concentricity Test Apparatus
5.
5.36.1 French Size Calibration Gauge, tolerance of 60.13
mm (60.005 in.).
PROCEDURE D: BALLOON CONCENTRICITY 5.36.2 Metric Scale Rule.
5.25 Scope—This test method is applicable for enteral
5.37 Hazards:
feeding devices with retention balloon to test the concentricy of 5.37.1 No lubrication or undue force shall be applied to the
the balloon.
enteral feeding device.
5.37.2 The edges of each hole should be smooth to avoid
5.26 Summary of Test Method—The retention balloon of the
interference to the passage of the test enteral feeding device.
enteral feeding device is inflated with water, and with the use
of a gauge, evaluted for concentricty. 5.38 Procedure:
5.38.1 Test at 23 6 4 °C (73.4 6 7 °F).
5.27 Significance and Use—This test is designed to quantify
5.38.2 Per Fig. 5, without lubrication, push the proximal end
balloon concentricity and the overall shape geometry of the
of the uninflated enteral feeding device through the various
balloon. It is the purpose of the balloon to retain the feeding
holes of the French size gauge, advancing it to the uninflated
device in position during use; therefore, the balloon must be of
balloon.
a functional uniformity that will not allow the enteral feeding
5.38.3 Uninflated balloon should fit in appropriate French
device to move from its desired position.
size gauge hole snugly without undue insertion force. Label
5.28 Apparatus—The testing apparatus is set up as shown in
each test unit and the measured French size. Remove device
Fig. 4.
from gauge.
3 3 3
5.28.1 Syringes—1 cm , 5 cm , and 60 cm .
5.39 Interpretation of Results—The balloon section may
5.28.2 Water.
wrinkle but shall not tear or distort, and the enteral feeding
5.29 Hazards—Not applicable.
device shaft or tip may offer resistance but if distortion or
5.30 Procedure: stretching occurs it is considered a failure.
5.30.1 Test at 23 6 4 °C (73.4 6 7 °F).
5.40 Precision and Bias—To be determined within five
5.30.2 Fill syringe with volume of water equal to balloon
years.
rating.
5.30.3 Attach syringe to enteral feeding device inflation
PROCEDURE F: BALLOON INTEGRITY
valve and inflate with water.
5.41 Scope—This test method is to evaluate the integrtity of
5.30.4 Per Fig. 4, use snap gauge and measure the two sides
the retention balloon of the enteral feeding device.
of the balloon that visually appear to have the least symmetry.
5.42 Summary of Test Method—The retention balloons are
Measurement should be taken 180° from each other.
inflated with water and submerged in water at 37.8 6 3 °C (100
5.30.5 Divide larger measurement by smaller measurement
6 5 °F) for seven days. The retention balloons are evaluated to
and quotient equals Concentricity Ratio. Tabulate all results.
determine if they hold their integrity and do not rupture.
5.31 Interpretation of Results—Balloon concentricity ratio
5.43 Significance and Use—This test method is designed to
must not exceed those established in Table 2.
subject the retention balloons to the inflation volume they
5.32 Precision and Bias—To be determined within five
would be subjected to during use in the field, in order to
years.
determine the integrity of the balloon. It is the purpose of the
balloon to retain the feeding device in position during use;
PROCEDURE E: BALLOON SIZE AND SHAFT SIZE
therefore, the performance of the retention balloon must be
5.33 Scope—This test method is to evaluate the retention
maintained and the balloon must not rupture.
ballo
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