ISO 17218:2014 PDF

Overview

ISO 17218:2014 - Sterile acupuncture needles for single use specifies requirements for single‑use, manufacturer‑sterilized filiform acupuncture needles. The standard covers needle configuration, types (with or without guide tube), handle designs, materials, dimensional tolerances, performance, sterility assurance, packaging, labelling, transit/storage and test methods. It is intended to support safe, consistent manufacture and clinical use of sterile disposable acupuncture needles.

Key topics and technical requirements

• Scope and configuration
  • Applies to filiform acupuncture needles for single use, sterilized by the manufacturer.
  • Defines parts of the needle: tip, body, root, handle and tail; needle types with/without guide tube; common handle styles (ring, plain, flower, metal tube, plastic).
• Materials and biocompatibility
  • Needle body biocompatibility must be assessed per ISO 10993‑1. Evidence may be based on published data, prior clinical use, traceability or specified biological tests (cytotoxicity, sensitization, intracutaneous reactivity, EO residuals).
  • Common needle body materials noted (examples): X5CrNi18‑9, X7CrNi18‑9 stainless steels (see ISO 15510).
• Dimensions and tolerances
  • Size designation is by nominal diameter × length (e.g., Ø 0.30 × 40 mm).
  • Example diameter tolerances:
    • 0.10 ≤ d