ISO 20493:2018 PDF

Overview

ISO 20493:2018 - Traditional Chinese medicine - Infrared moxibustion-like instrument - is an international standard that specifies safety, performance and testing requirements for infrared moxibustion-like instruments when used as medical devices. The standard defines device composition, required operating characteristics, protection against hazards, environmental and electrical testing, labeling, instructions for use, packaging, transportation and storage.

Key topics and technical requirements

• Device structure: instrument components include the infrared heater, back shield, front shield and working shield.
• Spectral output: the infrared moxibustion-like spectrum is primarily distributed in the 1 µm to 10 µm wavelength range.
• Temperature control:
  • Heater surface temperature must be maintained within ±10% of the manufacturer’s rated value.
  • Surface temperature unevenness ≤ 20% across defined test points.
  • Maximum surface temperature of front, back and working shields ≤ 56 °C.
• Time control:
  • Thermal response time ≤ 20 minutes (time to reach rated temperature).
  • Instrument must include an adjustable timer; timer accuracy error ≤ ±10% and must stop heating at set time with sound/light indication.
• Overheat and radiation protection:
  • A reliable thermal protective device is required.
  • Protection against unwanted or excessive radiation follows IEC 60601-1 Clause 10.
• Testing methods:
  • Wavelength testing with an infrared spectrometer.
  • Temperature testing: 9-point surface measurements after 20 min energization; unevenness calculation per formula in the standard.
  • Thermal response measured by contact thermocouple method.
• Labeling and documentation: indelible label with production unit, model, input power, serial number, production date, registration and standards. Instructions must explain irradiation exposure times and safe distances.
• Packaging & storage: moisture-proof, shock-resistant packing; storage suitable for packaged device at 40 °C to 55 °C, RH