ASTM-F2528 2023

$34.13

F2528-06(2023) Standard Test Methods for Enteral Feeding Devices with a Retention Balloon

Published By	Publication Date	Number of Pages
ASTM	2023	8

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Categories: 11.040.99 - Other medical equipment, ASTM

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Description

ASTM F2528-06-Reapproved2023

Active Standard: Standard Test Methods for Enteral Feeding Devices with a Retention Balloon

ASTM F2528

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.

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 Code

ICS Number Code 11.040.99 (Other medical equipment)

DOI: 10.1520/F2528-06R23

Additional information

Standard Title	F2528-06(2023) Standard Test Methods for Enteral Feeding Devices with a Retention Balloon
Published Code	ASTM
Publication Date	2023
Pages Count	8
ICS Codes	11.040.99 - Other medical equipment