ISO 11608-6:2022 specifies requirements and test methods for on-body delivery systems (OBDS) used to deliver a discrete (bolus) dose of a medicinal product through a needle or soft cannula for single-patient use.
If you need help mapping OBDS performance requirements to a practical verification setup (dose delivery, leakage, occlusion, or attachment integrity), talk with our team about your device concept and the edition you are working to.
Needle-based injection systems for medical use — Requirements and test methods — Part 6: On-body delivery systems (ISO 11608-6:2022)
This document is part of the ISO 11608 series covering needle-based injection systems for medical use. Part 6 focuses specifically on OBDS devices that are worn on the body and deliver a set volume (bolus) via a needle or soft cannula.
It is written for single-patient-use systems and is commonly used in design verification and validation planning for body-worn injectors, including systems with pre-filled or user-filled containers.
Quick Definition
What it is: An international standard defining requirements and test methods for bolus on-body delivery systems used for subcutaneous, intramuscular, or intradermal administration.
What it is not: A continuous-infusion pump standard (devices intended for continuous delivery at a set rate are excluded, though some methods can still be informative for pump development).
What This Standard Covers
ISO 11608-6:2022 addresses performance and safety-related requirements for OBDS that deliver a discrete dose through a needle or soft cannula. The scope includes systems intended for single-patient use and may incorporate replaceable or non-replaceable containers (pre-filled or user-filled).
Because OBDS combine drug-container integration, automated actuation, and body-worn attachment, this standard is often used to frame both device-level functional testing and system-level evaluation under realistic use conditions.
Why This Standard Matters in Testing
For OBDS programs, the highest testing risk is typically at the interfaces: dose delivery performance, leakage control, occlusion behavior, and reliable attachment to the body during wear and delivery. ISO 11608-6:2022 helps turn those risks into defined, repeatable test expectations.
In practice, teams use it to align verification evidence across design engineering, quality, and regulatory documentation by tying test setups and results to a recognized requirements-and-test-methods framework.
Common Materials, Product Types, or Applications Covered
This standard is used for body-worn injector-style products that deliver a bolus dose through either a rigid needle or a soft cannula (placed by a needle). Typical programs include wearable injectors for higher-volume subcutaneous delivery, automated bolus delivery devices intended to be worn during dosing, and OBDS concepts that integrate a drug container into a wearable platform.
It is commonly applied where a device must perform reliably while attached to the body and delivering through tissue, including scenarios where users apply the device themselves.
Common Test or Verification Workflow
ISO 11608-6:2022 is typically used as a verification roadmap rather than a single bench test. A common workflow is to define the OBDS configuration and intended route of administration, then plan test evidence around functional delivery performance and key failure modes.
Common workflow elements:
- Define the delivery mode (needle vs. soft cannula), container type (pre-filled or user-filled), and whether components are replaceable.
- Plan dose delivery performance evaluations appropriate to a discrete (bolus) delivery system.
- Evaluate leakage risks and fluid pathway integrity for the assembled system.
- Evaluate occlusion-related behavior relevant to bolus delivery through tissue pathways.
- Assess attachment/retention aspects relevant to body-worn use during wear and delivery.
Equipment Commonly Used for This Standard
The exact fixtures and instrumentation depend on the OBDS design and which clauses you are targeting. In most labs, ISO 11608-6:2022 drives a mix of benchtop measurement (dose delivery and leakage) plus mechanical evaluation for body-worn attachment and interface integrity.
Common equipment families: Gravimetric or volumetric dose-delivery measurement setups (balances, collection vessels, timing/data capture), pressure/flow instrumentation for fluid-path evaluations, leakage test rigs (application-specific), occlusion simulation or detection setups (application-specific), and mechanical force measurement for attachment/retention features (force gauges or universal testing systems with appropriate fixtures).
When your goal is to compare OBDS concepts or lock a verification configuration (instrumentation, channels, and fixturing), you can request a detailed quote for a setup matched to your device and test plan.
How to Read This Designation or Revision
ISO 11608-6 identifies Part 6 within the ISO 11608 series on needle-based injection systems for medical use.
:2022 indicates the year of publication for this edition (Edition 1, published in April 2022). When OBDS documentation cites this standard, test planning and reports should reference the exact edition/year to avoid requirement or method mismatches.
Related Standards, Methods, or Frameworks
ISO 11608-6:2022 notes that some requirements and methods are established in other parts of the ISO 11608 series, so OBDS programs often need to reference multiple parts of the family depending on the system architecture and components.
The document also distinguishes OBDS bolus systems from infusion pumps designed for continuous delivery; continuous-delivery pumps are addressed by IEC 60601-2-24 (electronic pumps) or ISO 28620 (non-electronic pumps).
Talk with us about ISO 11608-6 testing equipment
If you are specifying instrumentation for dose delivery, leakage, occlusion evaluations, or attachment-related mechanical testing, contact our team to scope a practical equipment path for your OBDS and the exact ISO 11608-6 edition you need to cite.