ASTM F2528-06 Standard Test Methods for Retention Balloon Enteral Feeding Devices

The standard "ASTM F2528-06 Standard test methods for enteral feeding devices with retention balloons" developed by the American Society for Testing and Materials (ASTM) describes test methods to determine the performance requirements for use of a disposable enteral feeding device with retention balloons used by medical professionals to provide nutrition or medication delivery to patients through a natural orifice (nasal, oral, transluminal) or surgically created stoma. The product is manufactured in a variety of sizes and materials, such as silicone, urethane, and various polymers or combinations thereof, and is supplied nonsterile for sterilization and sterile for single use only. The rationale for these test methods is included in the appendix of the standard (Appendix X1).

The test methods described cover the determination of performance requirements for use of a single-use enteral feeding device with a retention balloon used by medical professionals to provide nutrition or a means of administering medication to patients through a natural orifice (nasal, oral, transluminal) or surgically created stoma.

The test methods described in this standard are:

Feeding lumen flow rate test method, which includes determining the flow rates through the retention balloon drainage lumen of an enteral feeding device
Balloon burst volume test method for determining the balloon integrity of the enteral feeding device
Balloon volume maintenance test method applicable to enteral feeding devices with retention balloons to test the integrity of the inflation system to maintain the balloon volume of the enteral feeding device
Balloon concentricity test method that can be applied to enteral feeding devices with retention balloons to test the concentricity of the balloon.
Balloon size and shaft size test method to evaluate the shaft size of the retention balloon
Balloon integrity test method to evaluate the integrity of the retention balloon of the enteral feeding device
Balloon integrity testing method in simulated gastric fluid

These test methods evaluate the retention balloon's ability to withstand gastric acid levels without rupture and thus maintain its functional purpose of retention.

For the purposes of this standard, the following terms and definitions apply:

Balloon integrity (resistance to rupture) refers to the volume of fluid that would be required to fail or burst the balloon.
Distal refers to the balloon end of the feeding device.
The retention balloon enteral feeding device is a two-way medical device intended to provide nutrition or medication to patients, or both, through a natural orifice (nasal, oral, transluminal) or a surgically created stoma, or both. It consists of a drainage lumen and an inflation lumen. Common balloon inflation sizes are 5 cm3, 15 cm3, and 20 cm3.
French size refers to a scale used to indicate the size of catheters and other tubular instruments. The French size value is three times the outside diameter of the tube measured in millimeters. For example, a diameter of 18 Fr indicates a diameter of 6 mm.
Inflation volume refers to the volume of fluid used to inflate the holding balloon of the enteral feeding device for the test recommended in this standard.
Nominal volume refers to the volume of inflation of the holding balloon of the enteral feeding device as specified in the manufacturer's labeling and instructions for use.
Simulated gastric juice refers to a solution containing hydrochloric acid, salt, and pepsin with a pH of approximately 1,2 according to the USP standard recipe.
Sterility refers to the state of being free from living microorganisms.

All test samples for the above test methods must consist of new, finished, untested, unsterilized product from the manufacturer. At a minimum, the smallest and largest statistically valid samples of enteral feeding devices must be tested.

Among the numerous testing, measurement, analysis and evaluation studies that our organization has carried out for businesses in various sectors, it also provides testing services defined in the "ASTM F2528-06 Standard test methods for retention balloon enteral feeding devices" standard with its trained and expert staff and advanced technological equipment.