Overview
ISO 18746:2016 - Traditional Chinese medicine - Sterile intradermal acupuncture needles for single use defines safety, dimensional and performance requirements for sterile, single‑use intradermal acupuncture needles as medical devices. The standard covers needle size, materials, quality, testing methods, packaging, and identification, and distinguishes two common device types: intradermal granule type and intradermal thumbtack type. It aims to improve product consistency, biocompatibility and patient safety for intradermal acupuncture used in Traditional Chinese Medicine (TCM).
Key topics and technical requirements
- Scope and device types
- Applies to sterile intradermal needles intended for single use.
- Defines structural examples and measurements for granule and thumbtack types.
- Size designation
- Size is specified as nominal diameter × length (metric), e.g. Ø 0.16 × 10 mm.
- Dimensional tolerances and gauge measurement methods are specified for both needle types.
- Materials and biocompatibility
- Requires documented biological evaluation in line with ISO 10993‑1; common materials referenced include stainless steels listed in ISO 15510.
- New materials or coatings require re‑evaluation and potential ISO 10993 testing.
- Performance requirements
- Visual and microscopic inspection criteria for appearance and cleanliness (surface defects, sharpness of the tip).
- Drawing strength tests to ensure needle body remains attached to handle; specific minimum static forces are given for short needle bodies.
- References to apply hardness, tip puncture and strength tests consistent with ISO 17218.
- Sterility requirement: validated sterilization process (including guidance about ethylene oxide residuals per ISO 10993‑7 where applicable).
- Packaging and identification
- Primary packaging must form a microbial barrier; secondary packaging supports transport and storage.
- Labeling requirements include identification details and symbols consistent with ISO medical device labeling practice.
Applications and who uses this standard
- Medical device manufacturers designing or producing intradermal acupuncture needles (quality control, product design).
- Regulatory affairs and conformity assessment bodies assessing device compliance and safety.
- Clinical procurement teams and healthcare providers seeking certified single‑use sterile intradermal needles.
- Laboratories performing mechanical, sterility and biocompatibility testing.
Related standards
- ISO 10993‑1 - Biological evaluation of medical devices
- ISO 10993‑7 - Ethylene oxide sterilization residuals
- ISO 17218 - Sterile acupuncture needles for single use
- ISO 15223‑1 - Medical device symbols for labeling
Keywords: ISO 18746:2016, intradermal acupuncture needles, sterile single‑use needles, Traditional Chinese medicine, biocompatibility, sterilization, acupuncture needle standards, ISO 17218.