ISO 11608 Needle-Based Injection System Testing
Needle-based injection systems (NISs), or auto injectors, are used in a wide variety of applications where a drug or biologic product needs to be delivered via injection – typically either subcutaneously or intramuscularly. The performance requirements for injector pens and needles as defined in the ISO 11608 standard must be met before products can be brought to market. DDL offers testing for pen injectors, auto-injectors, and needle-based injection systems per ISO 11608 parts 1-6 in a GMP & ISO 17025 accredited lab.
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ISO 11608 Testing Capabilities
Complete testing for needle-based injection systems including pen injectors and auto-injectors.
ISO 11608-1 Pen Injector Testing
Dose accuracy, dose repeatability, and general requirements testing for needle-based injection systems per ISO 11608-1. Covers pen injectors with replaceable containers.
ISO 11608-5 Automated Functions
Testing for automated functions of needle-based injection systems including auto-injectors. Evaluates injection force, activation, and delivery performance per ISO 11608-5.
ISO 11608-2 Needles & Accessories
Testing for needles and associated accessories used with needle-based injection systems per ISO 11608-2. Includes needle penetration force and attachment security.
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REQUEST A QUOTEFrequently Asked Questions
What is ISO 11608?
ISO 11608 is a multi-part standard covering needle-based injection systems (NIS). It specifies requirements for the devices used to inject medicinal products through needles, including pen injectors, auto-injectors, and related components and accessories.
What do ISO 11608 Parts 1 through 6 cover?
Part 1 covers general requirements (dose accuracy, repeatability). Part 2 covers needles. Part 3 covers finished containers. Part 4 covers electronic and electromechanical requirements. Part 5 covers automated functions (auto-injectors). Part 6 covers on-body delivery systems.
What is the difference between pen injectors and auto-injectors?
Pen injectors are multi-dose, dial-a-dose devices where the user manually sets the dose and pushes the plunger (e.g., insulin pens). Auto-injectors are single-dose devices with automated needle insertion and drug delivery activated by a button or body contact. Both fall under ISO 11608.
What are the key testing requirements for ISO 11608?
Key tests include dose accuracy, dose repeatability, injection time, injection force, needle penetration force, container integrity, and device durability. Specific requirements depend on the device type and applicable part of ISO 11608.
How does DDL support ISO 11608 regulatory compliance?
DDL provides complete ISO 11608 testing with regulatory-ready reports suitable for FDA 510(k), PMA, and CE marking submissions. Our accredited lab tests to all applicable parts and provides expert guidance on testing strategies aligned with your regulatory pathway.