Overview
ISO/TS 20758:2019 sets the international technical specification for abdominal physiological parameter detectors used in Traditional Chinese Medicine (TCM). This standard defines the performance, safety requirements, materials, and testing methods for devices that measure physiological parameters-such as force, abdominal deformation, and temperature-on the abdominal area. It ensures reliable measurements while prioritizing patient safety and device biocompatibility.
Focused on non-invasive detection technology, this document does not prescribe the clinical interpretation of abdominal diagnostic data but provides a framework for consistent, accurate device functionality. Developed by ISO Technical Committee ISO/TC 249, the standard caters to developers, manufacturers, and medical practitioners using abdominal detection equipment within TCM practices.
Key Topics
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Force Detection
- Maximum applied force should not exceed 38 N
- Measurement range from 0.4 N to 25 N with resolution ≤ 0.3 N
- Accuracy within ±5% or ±0.4 N
- Overload capacity at least 250% of rated load with performance recovery after testing
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Dynamic Signal Measurement
- Detects pulsation signals linked to abdominal aorta pulsation
- Limits signal distortion within ±5% for accurate dynamic responses
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Geometrical Design of Sensors
- Stand-alone force detectors are hemispherical or hemicylindrical to prevent skin injury
- Haptic-type sensors must be flexible, thin, and preserve tactile sensitivity
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Abdominal Deformation Measurement
- Measures local deformation synchronously with applied force
- Resolution ≤ 1 mm and accuracy ±5% or ±1 mm
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Temperature Detection
- Ambient and abdominal temperature measurements from 15 °C to 40 °C
- Resolution ≤ 0.5 °C with accuracy ±5% or ±1 °C
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Biocompatibility
- Requires evaluation per ISO 10993-1 to ensure skin contact components are safe and non-toxic
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Test Conditions
- Standardized environmental parameters: 15°C–40°C, 30%–80% humidity, 86 kPa–106 kPa pressure
- Equipment must be preheated for 30 minutes for stability prior to testing
Applications
ISO/TS 20758:2019 applies to manufacturers and clinical institutions incorporating abdominal physiological parameter detectors in:
- Traditional Chinese Medicine diagnostics - Integration of abdominal measurements supports TCM practitioners in assessing patients based on physiological data.
- Medical device development - Guides design, performance requirements, and safety checks for devices that interact with the abdominal region.
- Clinical research - Facilitates consistent data collection and device validation when studying abdominal physiological parameters.
- Quality assurance and regulatory compliance - Enables manufacturers to meet international requirements for safety, accuracy, and biocompatibility, easing market access globally.
The standard supports innovation in non-invasive diagnostic tools that enhance patient comfort and improve measurement reliability in abdominal physiological monitoring.
Related Standards
- ISO 10993-1 – Biological evaluation of medical devices, fundamental for assessing biocompatibility of skin-contact materials used in abdominal detectors.
- ISO/IEC Directives, Part 1 and Part 2 – Provide guidelines on the development, editorial rules, and maintenance of ISO standards applicable in this technical specification.
By aligning with ISO/TS 20758:2019, stakeholders in Traditional Chinese Medicine and medical device manufacturing foster interoperable, safe, and effective technologies for abdominal physiological assessment.