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.
The most complex aspect of ISO 11608 compliance for manufacturers of needle-based injection systems (such as pen injectors and auto-injectors) lies in demonstrating mechanical integrity, functional performance, and component compatibility across all system elements. ISO 11608-1:2022 and ISO 11608-5:2022 are particularly demanding due to their emphasis on dosage accuracy, automated functions, and system-wide validation.
Ensuring dosage accuracy across the full operating range of a device—throughout its shelf life and under varying environmental conditions—is a central requirement of ISO 11608-1. Manufacturers must conduct extensive testing to prove consistent dosing performance and resistance to failure modes such as:
- Dose dialing inaccuracies
- Dose delivery malfunctions
- Environmental and user-induced variability
For devices incorporating automated or electronic features—such as electronic dose setting, usage recording, or Bluetooth-enabled dose tracking—ISO 11608-5 introduces additional regulatory considerations. These include:
- Software lifecycle validation (aligned with IEC 62304)
- Electrical safety and interference
- Human factors and usability (in conjunction with ISO 14971 and IEC 62366)
ISO 11608 requires a system-level view of testing. Every component—from the needle hub to the dose selector—must be evaluated in the context of overall system function. The testing burden often includes:
- Mechanical durability and environmental conditioning
- Biocompatibility and usability studies
- Software verification and validation
- Iterative revalidation following design changes
ISO 11608 specifies requirements and test methods for needle-based injection systems intended to be used with needles and with replaceable or non-replaceable containers. ISO 11608 is comprised of seven parts. DDL is able to carry out testing for the following parts of ISO 11608:
- ISO 11608-1 — Part 1: Needle-based injection systems
- ISO 11608-2 — Part 2: Needles
- ISO 11608-3 — Part 3: Finished Containers
- ISO 11608-5 — Part 5: Automated Functions
DDL also offers ISO 23908 – sharps injury testing in conjunction with ISO 11608 testing.
Our team works closely with device developers to plan and execute comprehensive validation programs that meet ISO requirements, support regulatory submissions and/or lot release testing.
Contact us for more information or to talk to an engineer.
