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  • ASTM
    F2528-06(2023) Standard Test Methods for Enteral Feeding Devices with a Retention Balloon
    Edition: 2023
    $86.11
    Unlimited Users per year

Description of ASTM-F2528 2023

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

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About ASTM

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide.
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