ISO 18615:2020

Overview

ISO 18615:2020 - Traditional Chinese medicine: General requirements of electric radial pulse tonometric devices - specifies the general requirements for basic safety and essential performance of pressure‑based radial pulse tonometric devices used in Traditional Chinese Medicine (TCM). The standard applies to medical electrical (ME) equipment that measures the radial pulse using a pressure transducer and actuator. It explicitly does not cover the accuracy of differential diagnosis or interpretation of diagnostic data.

Key topics and technical requirements

• Scope and normative reference: References IEC 60601-1 for general medical electrical safety and testing requirements.
• Definitions: Key terms such as pressure transducer, transducer module, actuator, pulse waveform, and the TCM pulse positions (inch/cun, bar/guan, cubit/chi).
• Marking and identification: Transducer modules or wristbands must include a visible radial artery position mark and position identification to prevent incorrect placement; separate indicators required for one‑finger and three‑finger methods.
• Instructions for use: Must include intended use and environment, list of specified accessories, compatible equipment, connection and placement procedures, cleaning/disinfection guidance, performance specs, ageing/environmental cautions, and troubleshooting messages.
• Actuator safety: Applied pressure for patient safety limited to 600 mmHg (80 kPa); automatic actuators must have mechanical limiters and in a single‑fault condition be limited to 660 mmHg (88 kPa).
• Accuracy of applied pressure: Measurement range at least 0–120 mmHg (16 kPa); resolution ≤ 2 mmHg; accuracy within ±5% of reading or ±6 mmHg, whichever is greater.
• Mechanical and signal stability: Actuator movement (mechanical or air‑bladder) must not introduce baseline fluctuations that affect pulse signal; transducer fault detection and lifespan/reliability requirements are addressed.
• Testing and annexes: Annex A covers radial pulse waveform and parameters; Annex B gives reliability test method and reference.

Applications and practical value

• Guides manufacturers in the design, verification and documentation of radial pulse tonometric devices to meet safety and essential performance expectations.
• Used by regulatory bodies and conformity assessment bodies for device evaluation and market approval.
• Useful for clinical engineers, product designers, QA/test labs, and procurement teams assessing device specifications and compatibility with IEC 60601‑1 requirements.
• Supports clear labeling, user instructions, infection control, and safe actuator design to protect patients and operators.

Related standards

• IEC 60601‑1:2005/AMD1:2012 - Medical electrical equipment: referenced for general safety and essential performance requirements.
• WHO TCM terminology resources are used for pulse position definitions (informative reference).

Keywords: ISO 18615:2020, electric radial pulse tonometric devices, radial pulse tonometry, pressure transducer, TCM pulse diagnosis, medical electrical equipment, IEC 60601-1.