Standard name: Needle-based injection systems for medical use — Requirements and test methods — Part 6: On-body delivery
Applicable medical devices:
This standard applies to on-body delivery systems (OBDS) which are applied onto the body for single patient use, intended for subcutaneous, intramuscular or intradermal delivery of a discrete volume (bolus) of medicinal product, through needles or soft cannulas, incorporating pre-filled or user-filled, replaceable or non-replaceable containers.
Testing capabilities to ISO 11608-6 include:
- Systems comprising rigid needles
- Systems comprising a soft cannula(s)
- Leakage from the OBDS
- Means of attachment for body-worn OBDS
- Functional performance requirements and test methods
- Dosing requirements and methods
- Sharps injury protection
- Automated functions
- Injection depth and needle extension
- Biological requirements of the OBDS
- Sterility of OBDS
- Medicinal product compatibility
- Extractables and leachables
- Electrical safety and software requirements
Other ISO 11608 Sections include:
- ISO 11608-2: 2022 Needles
- ISO 11608-3: 2022 Finished containers
- ISO 11608-4: 2022 Electronic and electromechanical pen-injectors
- ISO 11608-5: 2022 Automated functions
Part 2, 3 and 5 of ISO 11608 series specifies common test methods to support performance requirements for sterile double-ended needles and containers intended for use in conjunction with needle-based injection systems and the automated function of NISs.
In many instances, testing requirements are beyond the test method parameters set out in a standard. Alongside our standard testing services, our expert team is able to develop a custom testing program to meet your specific testing requirements and resolve and design or functionality issues you might have.
Please note: The information outlined above is to be used as a reference. Please refer to the appropriate competent standards agency in your country for full details and implementation of EN ISO 11608-6.
Download our ISO 11608 document for more information: