Bringing an injectable drug product to market requires confidence that the delivery system will perform safely and consistently throughout its intended lifecycle. The ISO 11608 series establishes internationally recognized requirements for needle-based injection systems (NIS), including pen injectors, autoinjectors, and other manually operated injection devices used to deliver products.
What is ISO 11608?
ISO 11608 governs the complete needle-based injection system for medical use. Unlike standards that address individual components in isolation, ISO 11608 takes a system-level view. Performing thorough testing of these devices during development and production is critical due to the importance in delivering medications. In the most extreme case, autoinjectors can deliver immediate, lifesaving intervention in the case of anaphylaxis or overdoses. This means that the device must reliably perform the minimum activation steps to meet safety requirements and to be reliably used by clinical workers and patients in their home. For manufacturers of combination products and drug delivery devices, this creates a more complex.
The parts of ISO 11608
Part 1: Needle-based injection systems — general requirements and test methods covering dose accuracy, essential performance, and system-level validation for devices delivering a discrete (bolus) volume of medicinal product.
Part 2: Needles — requirements and test methods for the needles used in conjunction with needle-based injection systems, including dimensional, mechanical, and needle-hub bond strength testing.
Part 3: Finished containers — requirements and test methods for the cartridges and containers used within a needle-based injection system, including compatibility with the delivery device and plunger interface.
Part 4: Electronic and electromechanical pen-injectors — requirements and test methods specific to pen-injectors with electronic components, such as dose setting, usage recording, and connected features.
Part 5: Automated functions — requirements and test methods for automated functions in needle-based injection systems, including medicinal product preparation, needle insertion, and retraction.
Part 6 (in development): On-body delivery systems — requirements and test methods for wearable, on-body injectors designed for larger volumes and longer delivery times, currently progressing through ISO’s draft standard review process.
Frequently asked questions
What products are covered by ISO 11608?
ISO 11608 applies to a variety of needle-based injection systems, including:
• Autoinjectors
• Pen injectors
• Fixed-dose injectors
• Variable-dose injectors
• Reusable injection systems
• Disposable injection systems
• Combination products with integrated injection devices
The applicable part of the ISO 11608 series depends on the design and functionality of the device.
Is ISO 11608 required for regulatory submissions?
While ISO 11608 is generally a voluntary consensus standard, demonstrating compliance is commonly used to support regulatory submissions for needle-based injection systems and combination products. Manufacturers often generate ISO 11608 testing data as part of design verification and validation activities to demonstrate device performance and safety.
What is tested under ISO 11608?
Testing varies depending on the applicable part of the standard but commonly includes evaluation of dose delivery accuracy, mechanical performance, activation forces, automated functions, environmental conditioning, durability, and compatibility between the injection device and its components.
Does ISO 11608 apply to autoinjectors?
Yes. Autoinjectors are one of the primary device types addressed by the ISO 11608 series. Depending on the device design, manufacturers may need to demonstrate compliance with multiple parts of the standard, including requirements for automated functions.
What is the purpose of ISO 11608 testing?
The purpose of ISO 11608 testing is to verify that a needle-based injection system performs safely and consistently under its intended conditions of use. Testing helps manufacturers evaluate device functionality, dose delivery performance, and overall reliability before commercialization.
Can ISO 11608 testing support design verification?
Yes. ISO 11608 testing is frequently incorporated into design verification programs to confirm that an injection device meets its intended performance requirements and design specifications before design validation and regulatory submission.