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

ASTM-F2528 - 2006 R23 EDITION - CURRENT
Show Complete Document History

Document Center Inc. is an authorized dealer of ASTM standards.
The following bibliographic material is provided to assist you with your purchasing decision:


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.

ORDER

Price:

$63.00        


Want this as a site license?

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.

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 and health practices and to determine the applicability of regulatory limitations prior to use.

Keywords

balloon; balloon concentricity; balloon integrity; balloon shaft size; burst; enteral feeding, enteral feeding device with retention balloon; flow rate; gastric fluid; inflation system integrity; lumen; performance requirements; ICS Number Code 11.040.99 (Other medical equipment)

To find similar documents by ASTM Volume:

13.02 (Emergency Medical Services; Search and Rescue; Anesthetic and Respiratory Equipment)

To find similar documents by classification:

11.040.99 (Other medical equipment)

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.

Document Number

ASTM-F2528-06R23

Revision Level

2006 R23 EDITION

Status

Current

Modification Type

New

Publication Date

July 7, 2023

Document Type

Test Method

Page Count

8 pages

Committee Number

F04.35