ISO 20308:2017

INTERNATIONAL ISO
STANDARD 20308
First edition
2017-05
Traditional Chinese medicine — Gua
Sha instruments
Médecine traditionnelle chinoise — Instruments Gua Sha
Reference number
©
ISO 2017
© ISO 2017, Published in Switzerland
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ii © ISO 2017 – All rights reserved

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
Foreword
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This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
iv © ISO 2017 – All rights reserved

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.
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;
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.
Key
1 handle for practitioner
2 body of Gua Sha instrument
3 side of scraping on skin
4 angle of scraping on skin
...