ISO 23958-2:2022

Overview

ISO 23958-2:2022 - Traditional Chinese medicine - Dermal needles for single use - Part 2: Roller-type specifies safety and essential performance requirements for roller-type dermal needles intended to penetrate the skin. It covers structure and dimensions, materials and biocompatibility, performance (appearance, puncture, hardness, corrosion resistance), sterility, packaging/identification, and transit and storage. This part applies only to single‑use roller-type devices and excludes tapping-type and reusable rollers.

Key topics and technical requirements

• Scope & device definition: Roller-type dermal needle = handle + rotating roller with evenly spaced micron‑needles designed to stimulate skin/meridians.
• Size designation: Metric size expressed as diameter × length (example: ⌀0.16 mm × 1.0 mm). Tolerances for nominal lengths and diameters are specified by ranges.
• Needle density & roller size: Indicative needle density is specified (typically 6–20 needles per cm², defined in the standard); roller diameter range 10–50 mm.
• Materials & biocompatibility:
  • Needle body commonly from austenitic stainless steels (e.g., X5CrNi18‑9 or X7CrNi18‑9 as referenced).
  • Handle/roller typically polycarbonate (PC) or equivalent engineering plastics.
  • Biocompatibility assessment per ISO 10993‑1; specific tests (cytotoxicity, sensitization, intracutaneous reactivity) and EO residuals per ISO 10993‑7 when applicable.
• Performance & quality:
  • Visual and microscopic inspection requirements (clean, bright, no burrs; needle tips smooth under 10× magnification).
  • Puncture performance referenced to ISO 17218.
  • Hardness requirement: Vickers hardness specified (refer to ISO 6507‑1 for testing); minimum ~350 HV as indicated.
  • Corrosion resistance, smooth roller rotation, and surface cleanliness criteria.
• Packaging & labelling:
  • Primary packaging must provide a microbial barrier; secondary packaging and identification requirements are defined for traceability and distribution.
• Transit and storage: Requirements to protect sterility, packaging integrity and device performance during distribution and storage.

Applications and users

• Manufacturers and product designers: guidance for designing, selecting materials, and setting production tolerances for single‑use roller dermal needles.
• Quality assurance & regulatory teams: benchmarks for testing, sterility, biocompatibility and labelling to demonstrate compliance.
• Purchasing and procurement: specification language for procurement of compliant roller-type dermal needles.
• Clinicians and TCM practitioners: assurance of single‑use device safety, sterility and consistency in clinical use.

Related standards

• ISO 10993‑1, ISO 10993‑7 (biological evaluation)
• ISO 17218 (sterile acupuncture needles - referenced for puncture testing)
• ISO 6507‑1 (Vickers hardness test)
• ISO 15223‑1 (medical device symbols)
• ISO 15510 (reference for commonly used stainless steels)

Keywords: ISO 23958‑2, roller‑type dermal needles, traditional Chinese medicine, single‑use dermal needle, sterility, biocompatibility, needle density, Vickers hardness, ISO 17218.