ISO 11608-6:2022

Overview

ISO 11608-6:2022 - "Needle-based injection systems for medical use - Requirements and test methods - Part 6: On-body delivery systems" defines safety and performance requirements and test methods for on‑body delivery systems (OBDS). It covers needle‑based injection systems (including systems that place a soft cannula by needle) intended for single‑patient use to deliver a discrete bolus subcutaneously, intramuscularly or intradermally. The standard applies to pre‑filled or user‑filled, replaceable or non‑replaceable containers and focuses on design outputs, risk control and verification rather than mandating specific construction details.

Key Topics and Requirements

ISO 11608-6:2022 organizes requirements relevant to the unique nature of body‑worn injectors. Major technical topics include:

• Risk assessment and usability engineering tailored to OBDS ergonomics (body‑worn vs patient‑worn).
• Physical and mechanical tests: needle/soft cannula behavior, means of attachment (adhesion), and resistance to leakage and occlusion.
• Functional performance: dose accuracy, dose delivery time and dose delivery profile, dosing methods, injection depth/needle extension, and automated functions.
• Sharps injury protection and device stabilization during extended deliveries.
• Biological requirements: sterility, biocompatibility, and patient tolerability.
• Medicinal product compatibility: particulates, pyrogenicity, extractables/leachables.
• Electrical safety and software requirements for electronic OBDS components and automated control.
• Inspection, information supplied by the manufacturer, and informative annexes (e.g., adhesion test methods, dose delivery profiles, in vitro methods for cannula displacement).

The document excludes continuous infusion pumps intended to maintain plasma concentration, though some test methods can inform pump design.

Applications and Who Uses It

ISO 11608-6:2022 is intended for:

• Medical device manufacturers designing OBDS, body‑worn patch injectors and wearable bolus delivery systems.
• Design engineers and R&D teams validating dose accuracy, adhesion and mechanical performance.
• Quality, regulatory and clinical affairs professionals preparing conformity evidence and submissions.
• Test labs performing performance, biocompatibility and sterility testing.
• Healthcare purchasers and clinicians evaluating device safety, patient tolerability and real‑world usability.

Practical uses include guiding product development, verifying manufacturing lots, preparing technical files, and informing risk‑based decisions about device features and labeling.

Related Standards

• ISO 11608-1, -3, -4, -5 (other parts of the needle‑based injection systems series)
• IEC 60601‑2‑24 (electronic infusion pumps)
• ISO 28620 (non‑electronic infusion pumps)

Keywords: ISO 11608-6:2022, on-body delivery systems, OBDS, needle-based injection systems, dose accuracy, dose delivery profile, sterility, biocompatibility, adhesion, usability engineering, device testing.