Many life-saving drugs are administered via medical needles, so ensuring that syringes perform safely and as intended is vital. Our Engaged Experts are ready to help your company mitigate risk and bring a safe product to market.
The mechanical properties of syringes are tested to ensure the device performs properly when exposed to different forces. There are several standards and regulatory guidance documents that outline functional syringe testing related to mechanical specifications, including ISO 7886, ISO 8537 and ISO 11608.
Mechanical Syringe Testing
Our syringe test methods include breakaway force/glide force, plunger actuation force, liquid leakage and needle penetration. We provide testing for a variety of needle-based injection systems, including:
- Single-use hypodermic syringes
- Pre-filled glass syringes
- Tapered and lock Luer fittings
- Pen injectors
- Auto injectors
The Element Advantage
We have extensive experience testing a variety of syringes and other medical devices. Our medical device experts assist in developing test protocols for your delivery system to support regulatory submissions and safe product use.
For more information about our syringe testing services or to request a quote, contact us today.
Standards we test to:
International Organization for Standardization
- ISO 7886-1 – Sterile hypodermic syringes for single use – Part 1: Syringes for manual use.
- ISO 8537 – Sterile single-use syringes, with or without needle, for insulin.
- ISO 11040-4 – Prefilled syringes – Part 4: Glass barrels for injectables and sterilized sub assembled syringes ready for filling.
- ISO 11608-5 – Needle-based injection systems for medical use – Requirements and test methods – Part 5: Automated functions.
- ISO 80369-20 – Small-bore connectors for liquids and gases in healthcare applications – Part 20: Common test methods.
As a comprehensive testing partner, you’ll enjoy the benefit of a single supplier source for all of your testing needs, from mechanical testing and environmental simulation to EMC and wireless device testing.
Our experts undertake a wide range of projects for medical device and pharmaceutical manufacturers, from pathogen and bioburden testing to endotoxin and cytotoxicity analyses.
Test Protocol for Medical Devices
A protocol and plan will mitigate your risk, prevent confusion, set clear expectations, and preserve the necessary information for future reference and use.
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