ISO 17218:2014

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 < 0.25 mm: ±0.008 mm
    • 0.25 ≤ d ≤ 0.45 mm: ±0.015 mm
    • 0.45 < d ≤ 0.80 mm: ±0.020 mm
  • Length tolerances vary with range (e.g., 5–25 mm ±0.50 mm; 25–60 mm ±1.00 mm; larger ranges with larger tolerances).
  • Minimum handle length: 13 mm.
• Performance and sterility
  • Surface cleanliness, straightness, absence of defects on body and handle.
  • Sharpness and puncture performance are emphasized; Annex A (tip sharpness/intensity) and Annex B (puncture tests) provide evaluation methods. Annex C covers corrosion resistance testing.
  • Sterility assurance requirements and package integrity for primary/secondary packaging are specified.
• Labelling, transit and storage
  • Labelling requirements for both primary and secondary packages and guidance for transit/storage conditions to preserve sterility.

Practical applications - who uses this standard

• Medical device and needle manufacturers: product design, material selection, QC tolerances and test methods.
• Quality, regulatory and compliance teams: conformity evidence, sterility assurance, biocompatibility documentation.
• Testing laboratories: implement Annex A–C test methods for tip performance and corrosion.
• Procurement and clinicians (acupuncturists, clinics, hospitals): product specifications, safe single‑use selection and labeling interpretation.
• Notified bodies/regulators: reference for device evaluation and market surveillance.

Related standards

• ISO 10993‑1 - Biological evaluation of medical devices
• ISO 14971 - Risk management for medical devices (recommended framework)
• ISO 15223‑1 - Symbols for medical device labelling
• ISO 6507‑1 - Vickers hardness test (referenced)
• ISO 15510 - Materials (referenced for commonly used stainless steels)

Keywords: ISO 17218:2014, sterile acupuncture needles, single use, filiform needles, needle dimensions, sterility assurance, biocompatibility, puncture performance, acupuncture needle standards.