ISO 11608 Testing Services
Needle-Based Injection Systems Testing
With over 60 years of experience, we provide comprehensive ISO 11608 testing to ensure compliance, reliability, and performance of Needle Injection Systems (NIS).
ISO 11608 sets the global standard for the design, performance, and safety of Needle-Based Injection Systems (NIS), ensuring compliance with regulatory requirements.
As a GMP, GLP, and ISO 17025 accredited laboratory with specific accreditation for ISO 11608-1:2022, we are a trusted partner for top medical device manufacturers worldwide.
Our Needle-Based Injection Systems Testing Capabilities
What are Needle Injection Systems?
Needle Injection Systems (NIS) are medical devices designed to deliver drugs or medicinal products into the body. Traditionally, these systems use hypodermic needles, these can either be staked or attached via a Luer, to penetrate the skin and administer the medication into the relevant tissues. Examples of NISs include Pre-filled Syringes, Pre-filled Pens and Auto-injectors.
The ISO 11608 series is a set of international standards developed by the International Organization for Standardization (ISO). The seven-part series details all aspects of NISs and includes requirements for design verification.
We offer expert testing for the ISO 11608 series, covering:
- ISO 11608-1Â Visual inspection, dose accuracy, life cycle testing, temperature, free-fall & vibration pre-conditioning as well as any tests determined to be Primary Functions of the NIS.
- ISO 11608-2Â Flow rate, hub-to-needle bond strength, patient-end dislocation, functional compatibility, and needle removal torque.
- ISO 11608-3Â Resealability, fragmentation, and particulate matter evaluation.
- ISO 11608-5Â Actuation force, needle extension, injection time, and safety activation.
- ISO 11608-6Â Dose delivery profile and adhesion testing.
Ensure Compliance, Reliability, and Market
Meeting ISO 11608 standards is essential for launching safe and effective needle-based Injection medical devices and pharmaceuticals.
We help manufacturers confidently navigate regulatory requirements, ensuring flawless performance and compliance.
With our expertise, clients:
- Achieve Regulatory Approval Faster – Our precise, accredited testing minimises delays and keeps projects on schedule.
- Enhance Product Reliability – Rigorous testing ensures devices perform consistently under real-world conditions.
- Strengthen Market Confidence – Compliance with ISO 11608 builds trust with regulatory bodies, healthcare providers, and patients.
Success Story:
A leading Combination Device manufacture partnered with Cormica to test their pre-filled syringe containing their latest bio-similar drug. Through our comprehensive test plans, based off ISO 11608-1:2022, including design verification testing, dose accuracy and stability studies they successfully submitted to their notified body, allowing them to achieve market approval and gain a competitive edge.
ISO 11608 Testing Frequently Asked Questions
ISO 11608-1 is the international standard that ensures the safety, accuracy, and performance of Needle-Based Injection Systems (NIS), including autoinjectors, pen injectors, and other drug delivery devices. Compliance with ISO 11608-1 is critical for manufacturers to achieve regulatory approval, enhance device reliability, and ensure patient safety. At Cormica, we provide accredited ISO 11608-1 testing to help manufacturers navigate these requirements with confidence.
ISO 11608 testing covers multiple aspects of needle injection system performance, including:
- Dose Accuracy & Primary Functions (ISO 11608-1)
- Needle Strength & Flow Rate (ISO 11608-2)
- Reservoir Integrity & Particulate Matter (ISO 11608-3)
- Injection Time & Safety Activation (ISO 11608-5)
- Adhesion & Dose Delivery Profile (ISO 11608-6)
At Cormica, we offer comprehensive, GMP, GLP, and ISO 17025-accredited testing to ensure your device meets all compliance and performance requirements.
With over 60 years of experience, Cormica specialises in efficient, end-to-end ISO 11608 testing. Our team helps identify and resolve potential compliance gaps early, reducing costly delays. We offer:
✔ Fast turnaround times to keep your project on schedule
✔ Customised testing solutions based on your devices unique needs
✔ Regulatory expertise to streamline approval processes
By working with Cormica, you ensure that your needle-based injection system is fully compliant, reliable, safe and market-ready.
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