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)

Needle penetration testing

custom

Surgical instrument impact testing

ISO 11608

Pen-injectors and needle-based injection systems

ISO 11953

Dentistry - hand torque instruments

ISO 13402

Hand instruments - resistance against autoclaving, corrosion and thermal exposure

ISO 13926-1

Glass cylinders for pen injectors

ISO 16061

Instruments for non-active surgical implants

ISO 7864

Sterile hypodermic needle testing

ISO 7864

Sterile hypodermic needle testing

Normative References

The international standard ISO 7864 specifies the requirements for sterile, single-use hypodermic needles intended primarily for the injection and withdrawal of fluids from the human body.

The standard includes, among others, the following test methods:

  • Verification of needle hub connection strength
  • Determination of flow rate to assess lumen patency
  • Measurement of penetration force and resistance characteristics
  • Evaluation of protection against sharps injuries in accordance with ISO 23908
  • Assessment of the conical (luer) connection in accordance with ISO 80369-1

Resources

This image shows Dipl. Ing. Christian Findeiss Head of Fatigue Testing & Material Analysis, Head of Vascular Testing at EndoLab

Your contact person

Dipl. Ing. Christian Findeiss

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