Sterile Hypodermic Syringe Testing (ISO 7886)

Smithers Pira are experts in testing of sterile single-use hypodermic syringes for design verification purposes

We help clients with testing which can be performed as part of product development testing or to show conformity with appropriate standard requirements and/or demonstrate that the functional performance of the product satisfies design requirements.

We develop and validate custom test protocols, which are subsequently used to provide evidence for regulatory submissions.

We perform testing on a variety of devices in accordance with ISO 7886 such as:

  • Syringes for manual use
  • Syringes for use with power driven syringe pumps
  • Auto-disable syringes for fixed-dose immunization
  • Syringes with re-use prevention feature

Typical sterile hypodermic syringe testing include:

Applicable standards:

  • Air leakage past plunger stopper during aspiration and separation of plunger stopper and plunger
  • Determination of dead space
  • Liquid leakage at syringe plunger stopper under compression
  • Determination of forces required to operate the piston
  • Testing of auto-disable feature
  • Testing of re-use prevention feature
  • ISO 7886-1
  • ISO 7886-2
  • ISO 7886-3
  • ISO 7886-4

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