Traditional Chinese medicine — General requirements for smokeless moxibustion devices
1Key Takeaways
This document specifies general requirements to ensure the performance and safety of smokeless moxibustion devices. It covers smoke density, moxibustion temperature, noxious gas and test methods for smokeless moxibustion devices. This document is applicable to any combustion-type device that claims to provide smokeless…
2Expert Interpretation
Comprehensive analysis of ISO 21366:2019 international standard for smokeless moxibustion equipment, covering core contents such as smoke density testing, harmful gas limits, material safety requirements, etc., providing standard implementation recommendations and comparative analysis of the old and new versions, to help standardize the development of traditional Chinese medicine equipment.
Analysis of core requirements of the standard
ISO 21366:2019 proposes three major technical system requirements for smokeless moxibustion equipment:
| Technical dimension | Specific requirements | Test standard |
|---|---|---|
| Smoke density | Optical density≤150±10 | ISO 5659-2:2017 |
| Harmful gases | CO≤100mg/m³(15min) | ISO 15011-2 |
| Material safety | Biocompatibility requirements | ISO 18666:2015 |
Detailed explanation of key technical indicators
Smoke generation test
The standard requires the use of a modified ASTM E662 test chamber. Key parameters include:
- Test duration: 10 minutes
- Number of sampling times: ≥3 times and take the median
- Corrected formula: Ds = Dm - Dc
In actual applications, it is found that the smoke density of carbonized moxa is usually 60-70% lower than that of traditional moxa sticks.
Comparative analysis of safety limits
Based on the WHO Indoor Air Quality Guidelines, comparison of major pollutant limits:
| Pollutants | 30 minute limit | 24 hour limit | Detection method |
|---|---|---|---|
| Formaldehyde | 0.1mg/m³ | - | ISO 16000-4 |
| TVOC | - | 0.26mg/m³ | ISO 16000-6 |
| NO2 | 200μg/m³ | 40μg/m³ | ISO 15011-2 |
Recommendations for the implementation of the standard
Manufacturers
- Establish a material carbonization process verification system
- Equipped with optical density detection equipment (it is recommended to use a dual-channel photoelectric detection system)
- Packaging drop test must comply with ISO 2248 requirements
Testing agency
Pay attention to test environment control:
- Temperature 10-35℃
- Relative humidity 25-75%
- Test interval ≥30 minutes
Technology Evolution Trends
Compared with ISO 18666:2015, this standard has the following main innovations:
- Added a new quantitative indicator for smoke optical density
- Introduced WHO air quality control standards
- Clarified the application specifications of carbonized materials
In the future, the real-time monitoring requirements for PM2.5/PM10 may be increased.