1、Traditional Chinese medicine Gua Sha instrumentsBS ISO 20308:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis British Standard is the UK implementation of ISO 20308:2017.The UK participation in its preparation was entrusted to Technical Commi
2、ttee CH/100/1, Traditional Chinese Medicine.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standa
3、rds Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 89494 7ICS 11.040.99Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July 2017.Amen
4、dments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS ISO 20308:2017 ISO 2017Traditional Chinese medicine Gua Sha instrumentsMdecine traditionnelle chinoise Instruments Gua ShaINTERNATIONAL STANDARDISO20308First edition2017-05-31Reference numberISO 20308:2017(E)BS ISO 20308:
5、2017ISO 20308:2017(E)ii ISO 2017 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2017, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including pho
6、tocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 7
7、49 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 20308:2017ISO 20308:2017(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Appearance 14.1 Shape . 14.2 Appearance 25 Material 26 Requirements 36.1 Visual inspection . 36.2 Cleaning and disinfectio
8、n . 36.3 Hardness . 36.4 Roughness . 36.5 Resistance to abrasion 36.6 Exposure index of radionuclide activity 36.7 Biocompatibility 47 Packaging . 47.1 Primary packaging . 47.2 Secondary packaging . 48 Transport and storage 59 Labelling and instructions for use . 59.1 Labelling . 59.1.1 Primary pack
9、aging . 59.1.2 Secondary packaging 59.2 Instructions for use . 5Annex A (informative) Test methods for surface roughness . 7Annex B (informative) Dimension and configuration of Gua Sha instruments 9Bibliography .13 ISO 2017 All rights reserved iiiContents PageBS ISO 20308:2017ISO 20308:2017(E)Forewo
10、rdISO (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 technica
11、l 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 ele
12、ctrotechnical 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
13、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
14、 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 con
15、stitute an endorsement.For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) se
16、e the following URL: www.iso.org/iso/foreword.html.This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.iv ISO 2017 All rights reservedBS ISO 20308:2017ISO 20308:2017(E)IntroductionGua Sha, also known as Gua Sha therapy, is a traditional treatment based on the m
17、eridian-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 thousan
18、d 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, Ja
19、pan, 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. ISO 2017 All rights reserved vBS
20、ISO 20308:2017This page deliberately left blankTraditional Chinese medicine Gua Sha instruments1 ScopeThis document specifies appearance, material, requirements of visual inspection, cleaning and disinfection, hardness, roughness, resistance to abrasion, exposure index of radionuclide activity, bioc
21、ompatibility 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 referencesThe following documents are referred to in the text in such a way tha
22、t 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 provi
23、ded by the manufacturer for the processing of resterilizable medical devicesISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management processISO/IEC Guide 37, Instructions for use of products of consumer interest3 Terms and definitionsFor the purpo
24、ses 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/obp3.1Gua Shath
25、erapy consisting of scraping or applying friction to the skin surface without causing abrasion or injury to the skin3.2Gua Sha instrumentinstrument made of hard material with different sizes and shapes for single or repeated usage during Gua Sha therapy4 Appearance4.1 ShapeA variety of shapes can be
26、 applicable as follows:a) oval-shaped;b) rectangle-shaped;INTERNATIONAL STANDARD ISO 20308:2017(E) ISO 2017 All rights reserved 1BS ISO 20308:2017ISO 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 instrument
27、s are given in Annex B.4.2 AppearanceThe general configuration of a Gua Sha instrument and the term for each part is shown in Figure 1.124Key1 handle for practitioner2 body of Gua Sha instrument3 side of scraping on skin4 angle of scraping on skinFigure 1 Example of the typical structure of a Gua Sh
28、a instrument5 MaterialA variety of materials can be applicable as below:a) buffalo-horn;b) bian-stone;c) jade;d) other materials.2 ISO 2017 All rights reservedBS ISO 20308:2017ISO 20308:2017(E)6 Requirements6.1 Visual inspectionWhen inspected with the naked eye:a) the surface of the Gua Sha instrume
29、nt shall appear flat, smooth, free from particles and extraneous matters, andb) any part of the Gua Sha instrument shall have no acute angle, crack or obvious deformation or damage.6.2 Cleaning and disinfectionGua Sha instruments for single or repeated use shall be in accordance with ISO 17664 in or
30、der to avoid skin irritation and infection6.3 HardnessAccording to Mohs hardness scale, the hardness of any type of Gua Sha instrument shall be no less than 3.6.4 RoughnessAfter polishing, the surface roughness of the Gua Sha instrument shall be no more than 6,3 m.NOTE For appropriate method to meas
31、ure the roughness, see Annex A.6.5 Resistance to abrasion6.5.1 The Gua Sha instrument shall have sufficient resistance to abrasion induced by 150 times of repeated disinfection.6.5.2 If the requirements for storage specified in this document have been met, there shall be no abrasion of the Gua Sha i
32、nstrument before the expiry date.6.6 Exposure index of radionuclide activity6.6.1 The internal exposure index is the quotient of specific activity of the radionuclide Ra-226 divided by the limits of the specific activity of the radionuclide Ra-226 specified in this document.ICRaRa=200(1)whereIRais t
33、he internal exposure index;CRais the specific activity of the radionuclide Ra-226, measured as “Bqkg1”;200 is the limit of the specific activity of the radionuclide Ra-226, measured as “Bqkg1”.6.6.2 The external exposure index is the quotient of the specific activity of the radionuclide Ra-226, Th-2
34、32 and K-40 divided by the limits of the specific activity of the radionuclide Ra-226, Th-232 and K-40 specified in this document. ISO 2017 All rights reserved 3BS ISO 20308:2017ISO 20308:2017(E)IC CCrRa Th K=+370 260 4200(2)whereIris the external exposure index;CRais the specific activity of the ra
35、dionuclide Ra-226, measured as “Bqkg1”;CThis the specific activity of the radionuclide Th-232, measured as “Bqkg1”;CKis the specific activity of the radionuclide K-40, measured as “Bqkg1”;370 is the limit of the specific activity of the radionuclide Ra-226, measured as “Bqkg1”;260 is the limit of th
36、e specific activity of the radionuclide Th-232, measured as “Bqkg1”;4200 is the limit of the specific activity of the radionuclide K-40, measured as “Bqkg1”.6.6.3 The internal exposure index of the Gua Sha instrument shall be no more than 0,5 and the external exposure index shall be no more than 0,6
37、5.6.7 BiocompatibilityThe biocompatibility of the Gua Sha instrument shall be assessed and documented according to the guidance and principles given in ISO 10993-1.Compliance is demonstrated by:a) analogy with published data; orb) the selection of materials already shown to be biocompatible by prove
38、n clinical use in a similar application; orc) experience with similar devices already on the market together with evidence of traceability to the materials used in the Gua Sha instrument; ord) compliance with published procedures for biological evaluation of medical devices.7 Packaging7.1 Primary pa
39、ckagingThe Gua Sha instrument shall be sealed in primary packaging. There shall be no foreign matter within the primary package under visual inspection.The material and design of this primary packaging shall not have detrimental effects on the contents. The material and design of this primary packag
40、ing should be such as to ensure:a) the maintenance of the contents under dry, clean and adequately ventilated storage conditions;b) the minimum risk of contamination of the contents during removal from the package;c) adequate protection of the contents during normal handling, transit and storage;d)
41、that once opened, the package cannot be easily resealed, and it shall be obvious that the package has been opened.7.2 Secondary packagingOne or more items of primary packaging shall be packaged in secondary packaging.4 ISO 2017 All rights reservedBS ISO 20308:2017ISO 20308:2017(E)The secondary packa
42、ging shall be sufficiently robust to protect the contents during handling, transit and storage.One or more items of secondary packaging may be packaged in storage and/or a transit package.8 Transport and storageOnce the Gua Sha instruments are packaged, they shall be kept in a clean, dry, well-venti
43、lated and non-corrosive environment. The storage environment shall protect the Gua Sha instruments from exposure to high humidity, high temperatures and direct sunlight.9 Labelling and instructions for use9.1 Labelling9.1.1 Primary packagingThe primary packaging shall be marked with at least the fol
44、lowing information:a) the name or trademark or logo of the manufacturer and/or supplier;b) a description of the contents, including the designated metric size;c) the lot number, prefixed by the word “LOT”, and/or date of manufacture;d) the expiry date;e) for a Gua Sha instrument intended for single
45、use, the words “For single use” or “Do not reuse” or symbol;f) material;g) dimension.9.1.2 Secondary packagingThe secondary packaging shall be marked with at least the following information:a) the name, address and trademark of the manufacturer and/or supplier;b) description of the contents, includi
46、ng the designated metric size, the quantity and the classification;c) the lot number, prefixed by the word “LOT”, and/or date of manufacture;d) expiry date;e) for a Gua Sha instrument intended for single use, the words “For single use” or “Do not reuse” or symbol;f) information for handling, storage
47、 and transportation;g) a warning to check the integrity of each item of primary packaging before use, such as “Do not use if packaging is damaged” or symbol.9.2 Instructions for useThe instructions for use shall be in accordance with ISO/IEC Guide 37. ISO 2017 All rights reserved 5BS ISO 20308:2017I
48、SO 20308:2017(E)The instructions for use shall be marked with at least the following information:a) introduction of the product;b) the name and trademark of the product and/or manufacturer;c) product license number;d) product standard number;e) performance and structure of product;f) indications and
49、 contraindications;g) methods to use, disinfection method in particular;h) precautions.6 ISO 2017 All rights reservedBS ISO 20308:2017ISO 20308:2017(E)Annex A (informative) Test methods for surface roughnessA.1 GeneralThe surface roughness is an important component of product quality, which has great influence on the safety of Gua Sha instruments. Based on the development of surface roughness measuring method, several commonly used methods are listed.Because every method has advantages and disadvantages, the ope
