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
Current Stage
6060 - International Standard published
Start Date
13-Dec-2018
Completion Date
18-Feb-2019
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ISO/TS 20758:2019 - Traditional Chinese medicine -- Abdominal physiological parameter detectors
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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
---------------------- Page: 1 ----------------------
ISO/TS 20758:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

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below or ISO’s member body in the country of the requester.
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Email: copyright@iso.org
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Published in Switzerland
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

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

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

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/patents).

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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
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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
...

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