Testing needle-based injection systems (NIS) to ISO 11608
Biologics, in particular new drugs in cancer therapy, GLP-1 drugs (modern agents for the treatment of type 2 diabetes and obesity) and patient-friendly injection systems are driving the development of modern drug delivery devices.
The ISO 11608 series of standards establishes worldwide requirements and test methods for cannula- or needle-based injection systems (NIS) – from pen injectors and autoinjectors to wearable injectors (OBDS). It specifies requirements for design verification and defines the mechanical testing, dose accuracy, and user safety of these systems, making it the key standard for device manufacturers, component suppliers, and pharmaceutical companies developing and qualifying drug-device combination products.
ZwickRoell offers a broad portfolio of precise, validated testing systems – from manual stand-alone solutions to fully automated high-throughput systems – compliant with ISO 11608-1 to -6 and other relevant standards. These manufacturer-independent testing solutions help companies worldwide to design their development and quality assurance processes efficiently, reproducibly across locations, and in accordance with standards.
ISO 11608 Overview Testing solutions Automation Areas of application Related webinar Reference/Customer projects
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Overview ISO 11608
ISO 11608 defines the requirements and test methods for needle-based injection systems (NIS) used for the safe administration of medications. These include pen injectors (e.g., insulin or GLP-1 pens), autoinjectors, OBDS, cartridges, and prefilled syringes used as part of these combination products.
The following table provides an overview of the content and focus areas of the individual parts of the standard:
| Standard | Title / Topic | Key content |
|---|---|---|
| ISO 11608-1 | Needle-based injection systems | Specifies the general requirements and test methods for injection systems that enable the dosing of liquid medications. This includes, among other things, functional reliability, dose delivery accuracy, mechanical strength, handling, temperature, and drop tests. These tests assess functional stability, i.e., the pen's ability to maintain its primary functions (dose accuracy and pen mechanics) over a specific period or number of actuations. |
| ISO 11608-2 | Needles | This refers specifically to needles or cannulas used in injection systems. Tests are intended to ensure the compatibility of the needle and pen, including the dose accuracy according to Part 1. |
| ISO 11608-3 | Cartridges | Defines requirements and tests for cartridges used in injection systems and includes tests to determine glide force, breakaway force and leak tightness for resealability. |
| ISO 11608-4 | NIS with electronic components | Requirements for electronic components, e.g. Bluetooth or app interfaces for dose monitoring, that do not require mechanical testing. |
| ISO 11608-5 | Automated functions | This refers specifically to tests on autoinjectors such as the pull-off force or tightening torque of the safety cap, activation force, injection time, dose accuracy, injection depth, safety functions of the needle shield, and the verification of optical and acoustic signals for the operator. |
| ISO 11608-6 | Wearable Injectors / OBDS | Applies to on-body delivery systems (OBDS).Refers to ISO 11608-1 and focuses on the accuracy of the injection volume: injection force, injection time, injection depth, and injection volume under real-world conditions (37 °C). |
| ISO 11608-7 | Accessibility | Usability and ergonomic requirements for people with visual impairments or limited motor skills. |
Customized testing systems according to ISO 11608 – from R&D to series production
ZwickRoell offers customized testing solutions for needle-based injection systems – from R&D and quality assurance to series production – that are precisely tailored to the requirements of the pharmaceutical industry, device manufacturers, CDMOs/CMOs, and component suppliers.
Our systems guarantee high-quality, precise, reproducible, and traceable test results, including data integrity and fully FDA 21 CFR Part 11 compliant documentation. High specimen throughput, supported by semi- or fully automated solutions, reduces turnaround times and operator influence when testing everything from pens to complex autoinjectors and OBDS devices, including their components.
Standardized, globally transferable test procedures and centralized data management ensure comparable quality standards at different locations and in global supply chains.
Automated cartridge testing
For reproducible testing of cartridges according to ISO 11608-3, ZwickRoell offers automated testing solutions for determining breakaway and glide forces as well as leak tightness using X-Y table setups. These enable sequential testing of up to 64 cartridges with reduced operator influence, high repeatability, and increased throughput – ideal for quality assurance, development, and validatable testing processes.
Fully automated testing of autoinjectors and pens
The automated testing system roboTest N can be used for pens and autoinjectors. They take care of specimen handling and perform all tests required by the standard. The system enables all relevant function tests to be performed on a single specimen within a single test cycle. This significantly reduces testing effort and the number of test specimens required while ensuring a complete functional analysis of the autoinjector or pen.
Additional options such as click or color recognition and a magazine extension up to 150 specimens can also be used. For pen testing, optical dosing field recognition and a priming station for removing air bubbles from the pen can also be added.
Precise sensor technology and a sequential testing process minimize operator influences such as misaligned insertion or measurement errors. The result is reproducible and reliable test results.
| Device | Pen | Autoinjector |
|---|---|---|
| Standard | ISO 11608-1 ISO 11608-2 ISO 11608-3 | ISO 11608-5 |
| Specimen handling system | roboTest N | roboTest N |
| Capacity | 30 - 150 pens | 30 - 150 autoinjectors |
| Additional options |
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Who is the ISO 11608 standard series relevant for?
The ISO 11608 series of standards is aimed at all companies that develop, manufacture, or test needle-based injection systems (NIS). This includes:
- Manufacturers of pens, autoinjectors, and wearable injectors (OBDS)
- Pharmaceutical companies that bring drugs to market in combination with injection systems
- Contract development and testing laboratories (CDMOs/CMOs) that perform tests on behalf of pharmaceutical companies
- Supplier of components such as cartridges, needles, seals, or electronic modules
Why are tests to ISO 11608 relevant?
ISO 11608 is the key international standard for the mechanical testing of needle-based injection systems (NIS) such as autoinjectors, pens, and on-body delivery systems (OBDS). Its relevance stems from several reasons:
- Patient safety:
Only standardized testing can ensure that an injection system is reliable, safe, and easy to use – regardless of whether it is used by medical professionals or the patient themselves. - Regulatory compliance and market approval:
For manufacturers, suppliers, and pharmaceutical companies developing drug-device combination products, compliance with ISO 11608 is a prerequisite for approval. It is recognized by international regulatory authorities such as the FDA and EMA as representing the state of the art. - Reproducible results:
The standard ensures that all relevant functions, from dose accuracy and activation force to injection depth, are tested objectively and reproducibly. This reduces user errors and the risk of complaints. - Efficient product development:
Early validation according to ISO 11608 helps shorten development cycles, standardize test processes, and implement risk management requirements in a targeted manner.
Webinar recording
In this webinar, Erik Berndt, Global Industry Manager for Medical & Pharma at ZwickRoell, explains the latest developments in the mechanical testing of needle-based injection systems (NIS) according to ISO 11608. Learn how autoinjectors, pens, and on-body delivery systems (OBDS) can be reliably tested – from design verification to series testing.
- Overview of ISO 11608 series (Part 1–6)
- Current activities in Technical Committee ISO/TC 84
- New: Power pack rear part testing – Testing of autoinjectors without medication
- Reproducible results through Daily Check & Poka-Yoke
- Fully and semi-automated testing systems with camera and AI
- Link to other standards (ISO 11040, ISO 23908, ISO 8362)
- Qualification and FDA-compliant software solutions
Medical industry downloads
- Industry Brochure: medical industry PDF 6 MB
- Industry brochure: Testing Solutions for Injections Systems PDF 3 MB
- Product Information: Traceable and Reliable Test Results in Accordance with FDA 21 CFR Part 11 PDF 1 MB
- Product Information: Qualification of ZwickRoell Testing Systems PDF 1 MB
