ISO 20308:2017

Traditional Chinese medicine — Gua Sha instruments

ISO20308:2017 specifies appearance, material, requirements of visual inspection, cleaning and disinfection, hardness, roughness, resistance to abrasion, exposure index of radionuclide activity, biocompatibility of Gua Sha instruments, as well as related information on package, transport and storage, labelling and instructions for use. Electro-devices and other forms are outside the scope of this document.

Médecine traditionnelle chinoise — Instruments Gua Sha

General Information

• Status: Published
• Publication Date: 18-May-2017
• ICS: 11.040.99 - Other medical equipment
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249 - Traditional Chinese medicine
• Current Stage: 9093 - International Standard confirmed
• Completion Date: 18-Nov-2022

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 20308
First edition
2017-05
Traditional Chinese medicine — Gua
Sha instruments
Médecine traditionnelle chinoise — Instruments Gua Sha
Reference number
ISO 20308:2017(E)
©
ISO 2017

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ISO 20308:2017(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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ii © ISO 2017 – All rights reserved

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ISO 20308:2017(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Appearance . 1
4.1 Shape . 1
4.2 Appearance . 2
5 Material . 2
6 Requirements . 3
6.1 Visual inspection . 3
6.2 Cleaning and disinfection . . 3
6.3 Hardness . 3
6.4 Roughness . 3
6.5 Resistance to abrasion . 3
6.6 Exposure index of radionuclide activity . 3
6.7 Biocompatibility . 4
7 Packaging . 4
7.1 Primary packaging . 4
7.2 Secondary packaging . 5
8 Transport and storage . 5
9 Labelling and instructions for use . 5
9.1 Labelling . 5
9.1.1 Primary packaging . 5
9.1.2 Secondary packaging. 5
9.2 Instructions for use . 6
Annex A (informative) Test methods for surface roughness . 7
Annex B (informative) Dimension and configuration of Gua Sha instruments .9
Bibliography .13
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ISO 20308:2017(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).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
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URL: w w w . i s o .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
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ISO 20308:2017(E)

Introduction
Gua Sha, also known as Gua Sha therapy, is a traditional treatment based on the meridian-acupoint
theory of traditional Chinese medicine (TCM). The specific Gua Sha instruments which have different
shapes and materials are adopted to perform scraping action to the skin during the Gua Sha treatment
so as to prevent or treat diseases.
Gua Sha has been used for more than two thousand years and has demonstrated medical benefits.
In recent years, Gua Sha has proved, according to many clinical research projects, to be effective in
treating more than 400 types of diseases. Now, it is widely accepted in many countries including China,
United States of America, Europe, Australia, Japan, Korea and other Southeast Asian countries.
The purpose of this document is to guarantee the safety and performance of Gua Sha instruments, so as
to promote the international trade of Gua Sha instruments and generalize the clinical application of Gua
Sha therapy.
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INTERNATIONAL STANDARD ISO 20308:2017(E)
Traditional Chinese medicine — Gua Sha instruments
1 Scope
This document specifies appearance, material, requirements of visual inspection, cleaning and
disinfection, hardness, roughness, resistance to abrasion, exposure index of radionuclide activity,
biocompatibility of Gua Sha instruments, as well as related information on package, transport and
storage, labelling and instructions for use.
Electro-devices and other forms are outside the scope of this document.
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 17664, Sterilization of medical devices — Information to be provided by the manufacturer for the
processing of resterilizable medical devices
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO/IEC Guide 37, Instructions for use of products of consumer interest
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:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
3.1
Gua Sha
therapy consisting of scraping or applying friction to the skin surface without causing abrasion or
injury to the skin
3.2
Gua Sha instrument
instrument made of hard material with different sizes and shapes for single or repeated usage during
Gua Sha therapy
4 Appearance
4.1 Shape
A variety of shapes can be applicable as follows:
a) oval-shaped;
b) rectangle-shaped;
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ISO 20308:2017(E)

c) notch-shaped;
d) triangle-shaped;
e) comb-shaped;
f) fish-shaped;
g) other shapes.
NOTE Dimensions and configurations of Gua Sha instruments are given in Annex B.
4.2 Appearance
The general configuration of a Gua Sha instrument and the term for each part is shown in Figure 1.
1
2
4
Key
1 handle for practitioner
2 body of Gua Sha instrument
3 side of scraping on skin
4 angle of scraping on skin
...