Overview
ISO 6559:2024 specifies requirements for the sterile three-edge needle for single use, a traditional Chinese medicine (TCM) acupuncture instrument. The standard covers the needle’s configuration, dimensions, material, mechanical and surface properties, sterility and biocompatibility requirements, test methods (including puncture force), and requirements for packaging, labelling, transit and storage. It explicitly excludes requirements for the handle, which differs structurally from the needle body.
Key topics and technical requirements
- Geometry & dimensions
- Whole length (L): 50–80 mm (±2.0 mm)
- Head length (L2): 1.5–20 mm
- Head widest diameter (d): 1–4.5 mm
- Body diameter (D): 1–3.5 mm (±0.30 mm)
- Material
- Must be stainless steel conforming to ISO 15510.
- Mechanical & surface properties
- Head hardness: ≥ 200 HV0.2 (test per ISO 6507‑1).
- Surface roughness (head): Ra ≤ 0.8 μm (test per ISO 21920‑3).
- Tip sharpness evaluated by puncture force (test method in Annex A).
- Corrosion resistance: no corrosion before expiry if storage conditions met (see ISO 17218:2014 Annex C).
- Sterility & biocompatibility
- Appearance & quality
- Tip must be sharp, burr-free; head faces smooth and triangular in section; body straight and defect-free.
- Packaging & labelling
- Sterile primary packaging sealed with no foreign matter; packaging materials must maintain sterility and integrity.
- Requirements for primary and secondary labelling and transit/storage conditions are specified.
Applications and users
ISO 6559:2024 is intended for:
- Manufacturers of acupuncture and TCM devices - to design, produce and certify single‑use three-edge needles.
- Quality assurance and R&D teams - to set material, dimensional, mechanical and surface control plans.
- Regulatory and compliance professionals - to support technical files and conformity assessments.
- Testing laboratories - to perform hardness, roughness, puncture force and corrosion resistance tests.
- Healthcare procurement and clinical practitioners - to specify safe, single‑use sterile needles for three-edge needle therapy.
Related standards
Key referenced standards include ISO 15510, ISO 6507‑1, ISO 21920‑3, ISO 10993 series, ISO 11135, ISO 11137‑1, ISO 17665, ISO 17218, and ISO 15223‑1 (labelling symbols). These provide the testing and validation framework linked to ISO 6559.
