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The hypodermic syringe performance based on the ISO 7886-1:2017: A narrative review
Krisdiyanto1,2, Raja Ariffin Bin Raja Ghazilla1, M Azuddin1
1CPDM, Department of Mechanical Engineering, Faculty of Engineering, University of Malaya, Kuala Lumpur, Malaysia.
Medicine
|January 10, 2023
Summary
Syringe performance is crucial for medical injections. Most hypodermic syringes meet ISO standards, but research often overlooks key performance aspects beyond dead space.
Area of Science:
- Medical Devices
- Biomedical Engineering
- Quality Control
Background:
- Syringes are essential for fluid and medicine delivery, with hypodermic syringe use surging post-COVID-19 pandemic due to vaccinations.
- The International Organization for Standardization (ISO) sets minimum specifications and testing procedures for hypodermic syringes to ensure effectiveness and quality.
- Key performance indicators for syringes include dead space, piston operation force, leakage (water and air), and plunger-barrel fitting.
Approach:
- This review analyzes existing research on hypodermic syringe performance testing.
- The weighing method is predominantly used by researchers to measure syringe dead space.
- Other ISO-recommended performance measures have received limited research attention.
Key Points:
- Most reviewed hypodermic syringes comply with the minimum specifications outlined by the ISO.
- Syringe dimensions and shape significantly influence the dead space volume.
- Researchers tend to focus on injection force and post-injection leakage rather than piston operation or plunger fit.
Conclusions:
- While most syringes meet basic ISO standards, comprehensive performance evaluation is lacking.
- Further research is needed to address under-examined performance metrics like plunger-barrel fitting and air/water leakage.
- Optimizing syringe design requires considering all ISO-recommended performance indicators for improved medical applications.
