Overview
ISO 22466:2021 - "Traditional Chinese medicine - Laser acupoint devices" specifies requirements and test methods for laser acupoint (laser acupuncture) devices. The standard covers device configuration and classification, key optical and electrical performance limits, safety and biological evaluation, electromagnetic compatibility, and required instructions for use. It is not applicable to carbon‑dioxide (CO2) lasers, and for combined devices it applies only to the laser features.
Key topics and technical requirements
- Configuration & classification
- Describes single‑probe vs multi‑probe devices and single‑beam vs cluster‑beam probes.
- Optical parameters
- Wavelength: peak wavelength required in the range 400–1 400 nm.
- Spot size: manufacturer‑specified maximum; tolerance ±10% (per ISO 11146‑1).
- Pulse repetition rate: pulsed lasers must meet manufacturer specification within ±10%.
- Output power: single‑beam maximum accumulated output power ≤ 200 mW (per ISO 11554).
- Energy density: cumulative maximum energy density during treatment ≤ 10 J/cm² for each beam (measurement per ISO 11554).
- Output independency: in multi‑probe devices each probe’s output energy density must be independent.
- Stability & indicators
- Power stability (CW) and energy stability (pulsed) tolerances ≤ 10%.
- Devices must provide visible or audible emission indicators (individual indicators for multi‑probe units).
- Target/aiming function
- For invisible infrared beams or non‑contact probes, an aiming/target‑indicating function is required with concentricity and diameter limits; the aiming light AEL must be **