Overview
ISO 23958-1:2022 specifies safety and performance requirements for tapping‑type dermal needles for single use used in Traditional Chinese Medicine (TCM). The standard covers design, structure and dimensions, materials, biocompatibility, performance (appearance, tip firmness, corrosion resistance), sterility, packaging and identification, and transit and storage. It applies only to tapping‑type devices capable of penetrating the skin and excludes roller‑type, reusable tapping heads, and devices with detachable tapping heads.
Key topics and technical requirements
- Structure & size designation: Size is expressed as “nominal diameter × nominal length” (example: ⌀ 0.16 mm × 1.0 mm). Typical dimensions in the standard include:
- Handle length: 120–250 mm (±5.0 mm)
- Needle body diameter: 0.35–0.80 mm (±0.02 mm)
- Needle lengths on stimulation heads: generally 3.0–5.0 mm (±0.50 mm)
- Types: Single‑headed (evenly spaced needles along concentric circles) and double‑headed (one extensive stimulation side and one intensive clustered side).
- Materials & biocompatibility:
- Needle body commonly stainless steel (e.g., X5CrNi18‑9 or X7CrNi18‑9).
- Handles and tapping heads typically polycarbonate (PC), ABS or similar stable materials.
- Biocompatibility assessment required per ISO 10993‑1; ethylene oxide residuals addressed by ISO 10993‑7 when applicable.
- Performance requirements:
- Appearance and cleanliness (clean, bright, free from defects)
- Firmness of needle tips and secure connection between head and handle
- Hardness and corrosion resistance of needle body
- Sterility assurance and packaging integrity (primary and secondary packaging, labeling)
- Packaging, transit & storage: Primary packages must form a microbial barrier; secondary packaging and identification rules support distribution and storage requirements.
Applications and practical value
ISO 23958-1:2022 is used to:
- Guide manufacturers in design, material selection, testing, and sterile packaging of single‑use tapping dermal needles.
- Support quality and regulatory teams in conformity assessment, risk management and product labeling.
- Inform testing laboratories on inspection criteria (dimensions, sterility, corrosion, tip firmness).
- Help procurement and clinical users (TCM practitioners, clinics) specify compliant products for safe patient use.
Keywords: ISO 23958-1:2022, dermal needles, tapping‑type, Traditional Chinese Medicine, single‑use needles, sterility, biocompatibility, packaging.
Related standards
- ISO 10993‑1 - Biological evaluation of medical devices (biocompatibility)
- ISO 10993‑7 - Ethylene oxide sterilization residuals
- ISO 15223‑1 - Medical device symbols
- ISO 6507‑1 - Vickers hardness test (referenced for needle hardness testing)