ISO/TS 20758:2019

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/TS 20758:2019(E)
©
ISO 2019

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ISO/TS 20758:2019(E)

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ii © ISO 2019 – All rights reserved

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ISO/TS 20758:2019(E)

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
© ISO 2019 – All rights reserved iii

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ISO/TS 20758:2019(E)

Foreword
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iv © ISO 2019 – All rights reserved

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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
...