Overview
ISO 18666:2021 - Traditional Chinese medicine - General requirements of moxibustion devices - defines safety, quality and performance expectations for moxibustion devices that use moxa floss (the combustion material) and remain on or over the human body during treatment. The document covers configuration, materials, temperature assessment, packaging, labelling, instructions for use and minimum requirements for moxibustion materials (moxa floss and moxa sticks). It applies to single‑use and reusable devices using moxa floss, and explicitly excludes electro‑moxibustion, infrared devices and direct moxibustion using loose moxa floss.
Key Topics
- Scope and definitions: Clear terminology for moxibustion device, body of device, moxa floss, moxa stick and moxibustion temperature.
- Configuration and design: Requirements for size, shape, ventilation, ash removal, mounting/support and safety barriers to prevent embers or ash falling onto skin. Devices for repeated use must provide temperature control or equivalent means to maintain safe moxibustion temperature.
- Materials and biocompatibility: Materials contacting the skin must be evaluated per ISO 10993‑1 and ISO/TS 10993‑19 for biological safety and PMT (physico‑chemical, morphological and topographical) characteristics. Device bodies should be low‑flammability, fire‑retardant and low thermal conductivity.
- Moxibustion materials: Moxa floss must be processed from Artemisia species, stored/dried under controlled conditions, free from foreign matter and meet a minimum fineness ratio. Moxa stick wrapper and adhesives must burn compatibly and not emit harmful substances.
- Temperature assessment and testing: Annex A provides test methods to determine moxibustion temperature at the skin surface; Annex B provides guidance on artificial drying of mugwort leaves.
- Safety, packaging and labelling: Environmental protection, primary/secondary packaging rules, transport/storage, and required instructions for use and labelling to support safe clinical application.
Applications
ISO 18666:2021 is intended for:
- Manufacturers and product designers of moxibustion devices and consumables (moxa sticks, holders, tubes).
- Quality assurance and regulatory teams establishing compliance, product specifications and biocompatibility evidence.
- Test laboratories performing moxibustion temperature and material safety testing.
- Healthcare providers and Traditional Chinese Medicine (TCM) clinics selecting safe devices and verifying instructions for use.
- Procurement and compliance officers needing standardized acceptance criteria for moxibustion products.
Adoption of ISO 18666:2021 helps reduce safety risks, improve product consistency and support market access for moxibustion devices.
Related Standards
- ISO 10993‑1 - Biological evaluation of medical devices - evaluation and testing within a risk management process
- ISO/TS 10993‑19 - Physico‑chemical, morphological and topographical characterization of materials
- ISO 15223‑1 - Symbols to be used with information supplied by the manufacturer
Keywords: ISO 18666:2021, moxibustion devices, moxa floss, moxa stick, Traditional Chinese medicine, device safety, biocompatibility.
