Overview
ISO 19614:2017 - "Traditional Chinese medicine - Pulse graph force transducer" defines the technical requirements, classification and test methods for transducers used to acquire pulse graphs from a patient’s radial artery for Traditional Chinese Medicine (TCM) pulse-condition analysis. The standard is limited to pressure/force transducers used in radial artery pulse acquisition and was prepared by ISO/TC 249 (Traditional Chinese medicine).
Key topics and requirements
ISO 19614:2017 covers both functional and environmental/performance requirements for pulse graph force transducers. Major technical topics include:
- Scope & definitions - clear terms (pulse graph, effective/auxiliary/applied plane, excitation, measuring range, FSO/FSS).
- Classification - types of transducers (e.g., array vs single) and output formats (analog, frequency, digital).
- Test conditions & preparation - environmental conditions, loading, preconditioning and warm-up procedures.
- Labelling and documentation - product marking and required technical descriptions for safe use.
- Electrical characteristics - input resistance (Ri), output resistance (Ro), excitation requirements and output formats.
- Performance parameters and errors:
- Full scale span (FSS) and full scale output (FSO)
- Linearity (terminal/end-point), hysteresis, repeatability, creep, offset stability
- Temperature effects - sensitivity and offset temperature drift
- Eccentricity - consistency across the effective plane
- Overload, vibration/impact, fatigue life
- Biological evaluation - alignment with ISO 10993-1 for biocompatibility testing.
- Annex A - informative transducer examples to aid implementation.
Applications and who uses this standard
ISO 19614:2017 is practical for stakeholders involved in the development, testing, certification and use of TCM pulse acquisition equipment:
- Medical device manufacturers designing TCM pulse sensors and diagnostic systems.
- Test and calibration laboratories performing performance verification and conformity testing.
- Regulatory and quality teams ensuring devices meet recognized performance and safety criteria.
- Clinical users and TCM practitioners evaluating device selection for consistent pulse data acquisition.
- Procurement specialists specifying performance and test requirements in supplier contracts.
Using ISO 19614 helps ensure reproducible radial artery pulse recordings, device safety, consistent calibration, and supports regulatory compliance and market acceptance.
Related standards
ISO 19614 references relevant standards for testing and biological evaluation, including:
- ISO 10993-1 (biological evaluation of medical devices)
- IEC 60068-2-6, -2-14, -2-27 (environmental testing: vibration, temperature change, shock)
Keywords: ISO 19614:2017, pulse graph force transducer, Traditional Chinese medicine, TCM pulse acquisition, radial artery sensor, transducer test methods, medical device standard.