ISO/TS 20758:2019

Traditional Chinese medicine - Abdominal physiological parameter detectors

This document specifies the general requirements for basic performance and safety of abdominal physiological parameter detectors. It covers the material, basic parameters and testing method of abdominal parameter detectors but does not prescribe the clinical abdominal diagnosis associated with the findings obtained from the devices.

Médecine traditionnelle chinoise — Détecteurs de paramètres physiologiques abdominaux

General Information

• Status: Published
• Publication Date: 17-Feb-2019
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249/WG 4 - Quality and safety of medical devices other than acupuncture needles
• Current Stage: 9020 - International Standard under periodical review
• Start Date: 15-Oct-2025
• Completion Date: 15-Oct-2025

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

• 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

• Dynamic Signal Measurement

  • Detects pulsation signals linked to abdominal aorta pulsation
  • Limits signal distortion within ±5% for accurate dynamic responses

• 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

• Abdominal Deformation Measurement

  • Measures local deformation synchronously with applied force
  • Resolution ≤ 1 mm and accuracy ±5% or ±1 mm

• Temperature Detection

  • Ambient and abdominal temperature measurements from 15 °C to 40 °C
  • Resolution ≤ 0.5 °C with accuracy ±5% or ±1 °C

• Biocompatibility

  • Requires evaluation per ISO 10993-1 to ensure skin contact components are safe and non-toxic

• 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.

Standards Content (Sample)

TECHNICAL ISO/TS
SPECIFICATION 20758
First edition
2019-02
Traditional Chinese medicine —
Abdominal physiological parameter
detectors
Médecine traditionnelle chinoise — Détecteurs de paramètres
physiologiques abdominaux
Reference number
©
ISO 2019
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
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Published in Switzerland
ii © ISO 2019 – All rights reserved

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Test conditions . 3
4.1 Ambient temperature, humidity, atmospheric pressure . 3
4.2 Warm-up. 3
4.3 Accuracy of the inspection equipment . 3
5 Technical requirements . 3
5.1 Force detection . 3
5.1.1 Maximum applied force . 3
5.1.2 Force measurement range and accuracy . 3
5.1.3 Resolution . 3
5.1.4 Accuracy . 4
5.2 Dynamic signal . 4
5.3 Overload capacity . 4
5.4 Geometrical shape of force detector. 4
5.5 Abdominal deformation along the direction of applied force . 5
5.6 Detection position (x, y) . 5
5.7 Temperature detection. 6
5.7.1 Ambient and abdominal temperature detection . 6
5.7.2 Ambient temperature detection . 6
5.7.3 Abdominal temperature detection . 6
5.8 Biocompatibility . 6
Foreword
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bodies (ISO member bodies). The work of preparing International Standards is normally carried out
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ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
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expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso
.org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
iv © ISO 2019 – All rights reserved

TECHNICAL SPECIFICATION ISO/TS 20758:2019(E)
Traditional Chinese medicine — Abdominal physiological
parameter detectors
1 Scope
This document specifies the general requirements for basic performance and safety of abdominal
physiological parameter detectors. It covers the material, basic parameters and testing method of
abdominal parameter detectors but does not prescribe the clinical abdominal diagnosis associated
with the findings obtained from the devices.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
abdominal physiological parameter detector
APPD
device which measur
...