ISO 11608-5:2022

Overview

ISO 11608-5:2022 - "Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions" defines requirements and test methods for automated functions in needle-based injection systems with automated features (NIS‑AUTO). Published as the second edition in 2022, this standard addresses the outputs of design and verification for NIS‑AUTO intended primarily for human medicinal administration. It clarifies what qualifies as an automated function (no user interaction after actuation) and explicitly excludes remote communication functions.

Key topics and technical requirements

The standard provides general requirements applicable to all automated functions and specific requirements and test methods for individual automated functions, including:

• Medicinal product preparation (e.g., reconstitution, reservoir filling)
• Needle preparation, hiding, shielding, removal and needle cover considerations
• Priming and dose setting requirements and verification
• Needle insertion, injection depth control, and intended injection depth definitions and tests
• Injection of the medicinal product (dose delivery, injection time) and dose accuracy testing
• Needle retraction (positioning and completion criteria) and disabling (end‑of‑life state)
• Recording of device functions (data and event logging)
• Test method topics: actuation, test conditions, needle inspection, injection time, retracted position, shielding before/after injection, and dose accuracy at intended depth

The document contains informative annexes (rationale, example dose‑accuracy test, needle extension) and cross‑references to related parts of the ISO 11608 series.

Practical applications and users

ISO 11608-5:2022 is used to:

• Guide design and verification of automated features in injector devices
• Define performance testing protocols for manufacturers and test laboratories
• Support regulatory submissions and conformity assessment by providing standardized test methods and definitions
• Inform risk management, labeling and instructions for use (IFU) where timing, depth, and completion indicators are critical

Primary users:

• Medical device manufacturers (R&D, verification/validation teams)
• Independent test labs and notified bodies
• Regulatory and quality assurance professionals
• Clinical engineers evaluating device safety/performance

Related standards

• ISO 11608-1:2022 - Needle‑based injection systems - Part 1: general requirements (use in conjunction)
• ISO 11608-3:2022 - Containers and integrated fluid paths
• ISO 23908:2011 - Sharps injury protection - sharps protection features

Keywords: ISO 11608-5:2022, needle-based injection systems, NIS-AUTO, automated functions, injection depth control, dose accuracy, test methods, medical device standards.