ISO 22236:2020 PDF

Overview

ISO 22236:2020 specifies safety and quality requirements for single‑use thread‑embedding acupuncture needles used in Traditional Chinese Medicine (TCM). The standard covers only the needle part of thread‑embedding devices (not the medical thread itself) and aims to promote device safety and support international trade of thread‑embedding acupuncture needles.

Key Topics

• Scope & classification
  • Applies to single‑use thread‑embedding acupuncture needles in two configurations: plunger type (needle separate from thread) and pre‑installed type (needle preloaded with thread).
• Materials
  • Needle tube and needle components must use stainless steel in accordance with ISO 9626 and ISO 15510.
  • Handles typically polypropylene or materials with similar mouldability and biostability.
  • Acceptable thread materials (for pre‑installed type) include polydioxanone, polycaprolactone, poly‑L‑lactic acid or similar.
• Mechanical & visual requirements
  • Needle tubes must be clean, straight, free of burrs and corrosion; tip inspected at 10× magnification for burrs or hooks.
  • Size designation uses metric diameter and nominal length; actual lengths must meet tolerances referenced to ISO 7864.
  • Maximum deflection requirement: **