ISO 11608-6: Testing of On-Body Delivery Systems (OBDS)
ISO 11608-6 describes the specific test requirements for testing on-body delivery systems (OBDS). All OBDS functions used during the application of the wearable injector must be tested. These include, for example, dosing accuracy, injection profile, actuation force, and audible signals. The goal is to determine reliable test results as a basis for development and robust quality assurance.
ISO 11608-6:Contents Typical test values What really matters Checklist Testing solution QualificationYpsomed reference Request a consultation
What exactly does ISO 11608-6 include?
Due to their specific application, OBDS have different testing requirements than handheld autoinjectors. Therefore, the separate standard ISO 11608-6 was introduced.
ISO 11608-6 includes:
- Test requirements such as dosing accuracy, injection time, injection profile and injection depth, with detailed information on determining and displaying dosing accuracy in Annex B
- For testing the automatic functions of the OBDS, it refers to ISO 11608-5
- Overview of the various test methods and standards for determining adhesive forces (Appendix A)
- ISO 11608-6 deliberately allows flexibility in the design of OBDS in order not to limit their diversity; however, the various design features and functionalities are, of course, taken into account in the risk assessment.
Together with the instructions for use in the package leaflet (IFU), ISO 11608-6 forms the basis for the risk assessment, which defines the individual testing requirements.
Typical test values for tests to ISO 11608-6
| Test value | Function | |
|---|---|---|
 | Actuation force | The force that the patient must exert to activate the OBDS. |
 | Audible signals / Click times | Audible signals indicate the start and end of the injection to the patient. The timing of these signals, which are usually audible as a "click," is recorded. |
 | Injection depth | The injection depth indicates the area of tissue into which the active ingredient is delivered. For an adhesive-wearable on-body delivery system (OBDS), it usually corresponds to the length of the visible needle. |
 | Injection time | The injection time describes the total time of dose delivery or individual dose intervals. See also injection time according to ISO 11608-6. |
 | Injection volume | The injection volume is the amount of injection delivered during the injection time. |
 | Injection profile | The injection profile compares the amount of adhesive dispensed to the injection time. |
 | Adhesive strength of the adhesive surfaces | Both the peel strength of the film and the adhesive strength on the patient's skin are determined. See also ASTM D3330, ISO 4578, EN 1939 |
zwickiLine: flexible, compact, and reliable
The zwickiLine is modular and highly flexible. Thanks to its space-saving design, it fits easily into any laboratory. Test tools can be changed quickly and easily, and test conditions can be adjusted just as easily.
This makes it a popular choice for research and development as well as quality control. Close cooperation between our developers and our customers has ensured that the zwickiLine also reliably meets individual requirements.
The zwickiLine is also available as a cleanroom-compatible testing machine with the corresponding certificate.
Ypsomed Customer Case
Watch the video or read the case study to learn how close collaboration between Ypsomed and ZwickRoell led to the development of the clever OBDS testing solution—and how it was implemented at Ypsomed.
What is an OBDS?
An on-body delivery system (OBDS) is an autoinjector worn on the body. OBDS are designed for the delivery of highly viscous biologics and larger injection volumes. They are attached to the patient's skin and can administer medication over a longer period of time than handheld autoinjectors or other needle-based injection systems.
OBDS are combination products. They have a reservoir for the medication, a needle for administration into the tissue, a drive system for delivering the appropriate amount of medication, operating, and display elements, and an adhesive surface for attaching the device to the patient's skin.
There are many names for on-body delivery systems: body-worn autoinjectors, wearable injectors, portable injection systems, bolus injectors, patch injectors and many more.
