Overview
ISO 21291:2019 - Traditional Chinese medicine - Therapeutic fumigation devices defines safety, performance and test requirements for therapeutic fumigation devices used in Traditional Chinese Medicine (TCM) steam therapies. The standard covers device classification (open vs closed; local vs whole‑body), required components (heating unit, decoction container, steam pathway, control and sensing units, treatment capsule/support for closed devices) and the test methods to verify conformity. It explicitly excludes decoction pieces themselves.
Key topics and technical requirements
- Device classification & components
- Open devices (exposed steam) and closed devices (treatment capsule).
- Components: heating unit, decoction container, steam outlet, temperature‑sensing elements (skin or capsule), control unit, steam pathway and patient support.
- Temperature protection
- Over‑temperature protection at steam outlet and at fumigated body areas: heating must stop automatically and alarm (auditory/visual) per IEC 60601‑1‑8.
- Open device body area limit and closed capsule limit: exceed 45 °C triggers automatic stop and alarm.
- Temperature control and display
- Set function: error between set and actual steam temperature ≤ ±2 °C.
- Real‑time display: sensor display error ≤ ±1 °C (skin or capsule sensors).
- Closed‑device temperature consistency within capsule: uniformity error ≤ ±3 °C across measurement points.
- Timing, safety and mechanical tests
- Treatment timing accuracy: ±30 s.
- Emergency stop: manual, non‑self‑resetting actuator (red, visible, accessible).
- Empty‑container heating prevention: automatic stop and alert.
- Patient support mechanical strength: withstand specified mass loading (135 kg unless otherwise specified).
- Instructions & biological safety
- Instructions must state decoction requirements, contraindications and supervisory use guidance.
- Normative references include ISO 10993‑1 (biocompatibility) and IEC 60601 series for electrical and electromagnetic safety and alarm performance.
- Test methods
- Typical tests use constant‑temperature tanks and specified measurement points and stabilization times to verify alarms, sensors and temperature consistency.
Applications and who uses this standard
- Manufacturers of TCM therapeutic fumigation devices - to design compliant products and prepare technical documentation and testing programs.
- Test laboratories and conformity assessors - for executing the specified test methods and validating safety/performance claims.
- Healthcare providers and clinics - to understand device safety features, operational limits and supervision requirements for clinical use.
- Regulators and procurement officers - to set acquisition specifications and evaluate compliance for medical/therapeutic steam devices.
Related standards
- ISO 10993‑1 (biological evaluation of medical devices)
- IEC 60601‑1 and collateral standards (electrical safety, EMC, alarms)
- IEC 60601‑2‑52 (medical beds - relevant for whole‑body capsule support)
Keywords: ISO 21291:2019, therapeutic fumigation devices, Traditional Chinese Medicine, TCM steam therapy, temperature protection, device testing, medical device safety.