ASTM F2528

ANSI/AAMI NS28:1988/(R) 2006

Intracranial pressure monitoring devices

ASTM F1089

Corrosion of surgical instruments

ASTM F2528

Enternal feeding devices

ASTM F3014 (PI-94)

Standard test method for penetration testing of needles used in surgical sutures

ISO 11608

Pen-injectors and needle-based injection systems

ISO 11953

Dentistry - Implants - Clinical performance of hand torque instruments

ISO 13402

Surgical and dental hand instruments – Determination of resistance against autoclaving, corrosion and thermal exposure

ISO 13926-1

Glass cylinders for pen injectors

ISO 16061

Instruments for non-active surgical implants

PI-100

Bone anchoring systems

Enternal feeding devices

Normative References

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

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.  

Contact Person male

Your contact person

Dipl. Ing. Christian Findeiss

Head of Fatigue Testing & Material Analysis, Head of Vascular Testing