Overview
ISO 21366:2019 "Traditional Chinese medicine - General requirements for smokeless moxibustion devices" defines performance, safety and testing requirements for combustion‑type devices that claim to provide smokeless moxibustion. The standard is applicable to devices using moxa or carbonized herbal materials as the main combustion material, and excludes non‑combustion imitators such as electro‑ or infrared moxibustion. Its goal is to protect indoor air quality, patient safety and product reliability for modern moxibustion devices.
Key Topics and Requirements
- Scope and definitions: Clarifies terms such as moxibustion device, smokeless moxibustion device, smoke density, tVOC, aldehyde and others.
- Smoke density and generation tests: Test methods are provided (Annex B and C) to determine whether a product can be labelled “smokeless” based on measured smoke density and smoke generation behavior.
- Noxious gas emissions: Emission testing requirements cover carbon monoxide (CO), nitrogen dioxide (NO2), total volatile organic compounds (tVOCs) and aldehydes. Measurement methods reference established standards (e.g., ISO 15011‑2 for CO/NO2, ISO 16000‑6 for tVOCs, ISO 16000‑4 for aldehydes).
- Moxibustion temperature and materials: Temperature performance and biocompatibility of materials in contact with the body follow requirements in ISO 18666:2015.
- Packaging and labelling: Use of the statement “smokeless” is restricted to devices that meet the standard’s test criteria. Packaging must protect products from damage (protection performance referenced to ISO 2248).
- Indoor air quality alignment: Annex A summarizes WHO indoor air quality guidelines (particulate matter, VOCs, formaldehyde, CO, NO2) as reference values for acceptable emissions.
Practical Applications and Who Uses This Standard
ISO 21366 is intended for:
- Manufacturers and product designers developing combustion‑type smokeless moxibustion devices to ensure performance, safety and market claims.
- Testing laboratories carrying out smoke density, emissions and temperature tests to verify compliance.
- Regulatory bodies and conformity assessors evaluating safety, labelling and indoor air quality impacts.
- Healthcare providers and procurement teams (TCM clinics, hospitals, wellness centers) that need objective criteria when selecting smokeless moxibustion products.
- Quality and compliance managers documenting product claims and packaging requirements.
Practical uses include product development, pre‑market safety testing, supplier audits, labelling verification and procurement specifications to reduce moxibustion smoke, odour and harmful emissions while meeting recognized indoor air quality benchmarks.
Related Standards
Keywords: ISO 21366, smokeless moxibustion devices, moxibustion smoke, indoor air quality, noxious gas, smoke density, traditional Chinese medicine, tVOCs, WHO guidelines.
Open preview (PDF)Traditional Chinese medicine — General requirements for smokeless moxibustion devices