ISO 23908:2024

Overview

ISO 23908:2024 - Sharps injury protection - specifies requirements and test methods for sharps injury protection mechanisms (SIPMs) used with single‑use needles, catheter introducers and needles for blood testing, monitoring, sampling and medical substance administration. The standard covers SIPMs that are integrated or provided for assembly prior to use and focuses on minimizing accidental sharps injuries after intended use, including the path to safe disposal or recovery.

The document is intended to support device design verification, usability evaluation and conformity assessment using a risk‑based approach aligned with ISO 14971 and usability engineering principles.

Key topics and technical requirements

• Scope and exclusions: applies to single‑use sharps and many sampling/administration devices; excludes blunt‑tip medication‑loading devices, certain ENT/ophthalmic invasive products and solid‑core surgical needles due to usability trade‑offs.
• SIPM types: covers both active SIPMs (A‑SIPM) that require user activation and passive SIPMs that activate automatically.
• Performance and usability tests:
  • Activation testing (deployment reliability and repeatability).
  • Security of safe‑mode protection (resistance to overriding/unlocking).
  • Free fall test (added in 2024): pass/fail based on non‑access to the sharp after a fall - addresses common misuse scenarios.
  • Tests for access to the sharp in safe mode, with a minimum challenge force (5 N) required to assess access resistance.
  • Gauge R&R and destructive test considerations updated (destructive test threshold linked to 30% of the specification interval).
• Information requirements: marking, labelling and instructions for use (IFU) consistent with ISO 20417 and IEC/ISO usability guidance.
• Risk and usability integration: manufacturers must use a risk‑based approach (ISO 14971) and user‑interface evaluations (IEC 62366‑1) to verify SIPM performance for intended users and settings.

Practical applications and users

Who uses ISO 23908:2024:

• Medical device manufacturers designing needle‑based and sampling devices with SIPMs.
• Product development teams conducting design verification and usability testing.
• Test and certification laboratories performing SIPM performance and safety tests.
• Regulatory and procurement professionals assessing device safety for healthcare settings.
• Health‑care facilities evaluating devices for safer disposal, recovery or recycling programs.

Practical uses:

• Designing safer post‑use protection mechanisms to reduce blood‑borne pathogen risk.
• Defining test protocols (activation, free fall, access resistance) for conformity evidence.
• Preparing labeling and IFU that explain safe activation and disposal pathways.

Related standards

• ISO 14971 (risk management)
• IEC 62366‑1 (usability engineering)
• ISO 11608‑1 (needle‑based injection systems)
• ISO 20417 (information supplied by manufacturer)
• ISO 23907 series (sharps containers)

Keywords: ISO 23908:2024, sharps injury protection, SIPM, single‑use needles, test methods, medical device safety, usability, risk management.