1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Traditional Chinese medicine Air extraction cupping deviceBS ISO 19611:2017 ISO 2017Traditional Chinese medicine Air extraction cupping deviceMdecine traditionnelle chinoise Dispositif de bombement extraction dairINTERN
2、ATIONALSTANDARDISO19611First edition2017-05Reference numberISO 19611:2017(E)National forewordThis British Standard is the UK implementation of ISO 19611:2017. The UK participation in its preparation was entrusted to Technical Committee CH/100/1, Traditional Chinese Medicine.A list of organizations r
3、epresented 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 Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978
4、0 580 86876 4ICS 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 30 June 2017.Amendments/corrigenda issued since publicationDate Text affected BRITISH
5、STANDARDBS ISO 19611:2017 ISO 2017Traditional Chinese medicine Air extraction cupping deviceMdecine traditionnelle chinoise Dispositif de bombement extraction dairINTERNATIONAL STANDARDISO19611First edition2017-05Reference numberISO 19611:2017(E)BS ISO 19611:2017ISO 19611:2017(E)ii ISO 2017 All righ
6、ts 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 photocopying, or posting on the internet or
7、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 22 749 01 11Fax +41 22 749 09 47copyrightiso.
8、orgwww.iso.orgBS ISO 19611:2017ISO 19611:2017(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Configuration . 24.1 Configuration of cupping device 24.2 Dimensions . 34.2.1 Inner volume . 34.2.2 Smoothness of the skin contacting edge . 44.2.3 Diameters of ai
9、r outlet 45 Requirements 45.1 Biological compatibility. 45.2 Performance requirements 45.2.1 Resisting negative pressure 45.2.2 Pressure maintenance . 45.2.3 Mechanical stability 55.2.4 Transparency 55.2.5 Repeated disinfection resistance . 55.3 Sterilization and disinfection 55.3.1 Sterilization fo
10、r single-use type devices 55.3.2 Disinfection for multiple-use type devices 56 Package . 56.1 Primary package 56.2 Secondary package 57 Labelling 67.1 General . 67.2 Primary package 67.3 Secondary package 6Annex A (normative) Test methods for a cupping device . 7Bibliography 9 ISO 2017 All rights re
11、served iiiContents PageBS ISO 19611:2017ISO 19611:2017(E)ForewordISO (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
12、. 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 Intern
13、ational 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 diff
14、erent 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 s
15、hall 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 docum
16、ent 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 expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Org
17、anization (WTO) principles in the Technical Barriers to Trade (TBT) see 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 19611:2017ISO 19611:2017(E)IntroductionCuppin
18、g therapy is one of the most widely used traditional medical methods, which creates a partial vacuum in cups placed on the skin either by means of heat or mechanical devices (hand or electrical pumps). In the Middle East, cupping therapy has been used since 1550 B.C. and widely spread by Muhammad as
19、 Hijama. In East Asia, cupping therapy has been used since the Han dynasty and developed to slide cupping, medicated cupping, retained cupping, etc. In Europe, cupping also has been used since the Greek era and developed as cupping therapy in England, Schrpfkopf in German, Ventouse in France, Vanka
20、in Russia, etc. These days, cupping devices are commonly used in traditional therapies through various techniques. Even though cupping device is widely used and produced in a number of countries and companies, there is no international standard for cupping device yet. In the aspect of safety, the cu
21、pping device directly contacts the skin, and in the case of bloodletting cupping, it directly contacts open wounds which involves bleeding. To prevent wound infection, it should be distinguished and developed differently in the case of intact skin or wounded skin usage. In addition, as a medical dev
22、ice that directly contacts blood, it requires the use of disposable cups. The performance requirements specified in this document are needed. ISO 2017 All rights reserved vBS ISO 19611:2017BS ISO 19611:2017Traditional Chinese medicine Air extraction cupping device1 ScopeThis document specifies requi
23、rements for an air extraction cupping device which operates using negative pressure. This document includes requirements for the material, pressure, sterilization or disinfection, and packaging of the cupping device, as well as appropriate test methods.The document is applicable to single-use type a
24、nd multiple-use type devices.This document does not apply to the suction pump used to create the negative pressure.2 Normative referencesThe 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
25、, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 10993 (all parts), Biological evaluation of medical devicesISO 11135, Sterilization of health-care products Ethylene oxide Requirements for the development,
26、validation and routine control of a sterilization process for medical devicesISO 11137-1, Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devicesISO 15223-1, Medical devices Symbols to be used
27、 with medical device labels, labelling and information to be supplied Part 1: General requirementsISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devicesISO 17665-1, Sterilization of health care products Moist he
28、at Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.ISO and IEC maintain terminological databases for use in standardization at th
29、e following addresses: IEC Electropedia: available at h t t p :/ www .electropedia .org/ ISO Online browsing platform: available at h t t p :/ www .iso .org/ obp3.1cupping therapytherapy in which cups are placed on the skin to create localized negative pressure (3.8) by means of either heat or a suc
30、tion pump (3.7), for affecting the surface of the body or for increasing bloodletting (3.2)3.2bloodlettingtherapeutic method of withdrawing blood by pricking the skin with a needle in order to treat or prevent illness and diseaseINTERNATIONAL STANDARD ISO 19611:2017(E) ISO 2017 All rights reserved 1
31、BS ISO 19611:2017ISO 19611:2017(E)3.3air extraction cupping devicedevice for medical cupping, which consists of a body, an air outlet (3.5) and a valve unit for the air outlet3.4body of the cupping devicedevice which maintains negative pressure (3.8) generated by a suction pump (3.7) and has an inte
32、rnal cavity and an open end to contact the body surface3.5air outletmeans, in the upper part of the cupping device, for connecting to a suction pump (3.7) to deliver negative pressure (3.8) generated by the suction pump3.6valve unit for air outletone-way valve installed at the air outlet (3.5) to de
33、liver the negative pressure (3.8) generated by a suction pump (3.7)3.7suction pumpdevice for generating negative pressure (3.8) in a cupping device3.8negative pressureair pressure generated by a suction pump (3.7) in the inner cavity of the body of the cupping devices (3.4)3.9single-use type deviced
34、isposable cupping device for bloodletting cuppingNote 1 to entry: This type of cupping device is used when contact with blood and body fluids is likely.3.10multiple-use type devicecupping device for multiple-use which is used on intact area of skin with non-bloodletting cuppingNote 1 to entry: This
35、type of cupping device is used when contact with blood and body fluids is not likely.4 Configuration4.1 Configuration of cupping deviceThe configuration of the cupping device and the name of each of its parts are shown in Figure 1.2 ISO 2017 All rights reservedBS ISO 19611:2017ISO 19611:2017(E)Key1
36、body of cupping device2 air outlet3 valve unit for air outlet4 inner volumeFigure 1 Example of a typical structure of a cupping device4.2 Dimensions4.2.1 Inner volumeThe inner volume of the cup shall be specified as shown in Table 1.Table 1 Inner volume of the cupDimensions in millilitresCup number
37、Inner volume1 70 72 55 5,53 40 4,04 25 2,55 15 1,5 ISO 2017 All rights reserved 3BS ISO 19611:2017ISO 19611:2017(E)4.2.2 Smoothness of the skin contacting edgeThe skin contacting edge of the body of the cupping device shall be sufficiently rounded to prevent injury in the surface of the skin during
38、the cupping treatment. The roundness of the skin contacting edge shall be assessed by visual inspection.4.2.3 Diameters of air outletThe air outlet shall at least have a portion of its outer diameter measuring 11 mm.5 Requirements5.1 Biological compatibilityThe body of the cupping device intended to
39、 be exposed to blood during the bloodletting cupping technique shall be assessed and documented according to the guidance and principles given in the ISO 10993 series.Compliance is demonstrated bya) analogy with published data,b) the selection of materials already shown to be biocompatible by proven
40、 clinical use in a similar application,c) experience with similar devices already on the market together with evidence of traceability to the materials used in cupping device, ord) by compliance with published procedures for biological evaluation of medical devices (see Table 2).Table 2 Biological e
41、valuation for typeBiological evaluationTypeSingle-use type device Multiple-use type device1) Cytotoxicity X X2) Sensitization X X3) Intracutaneous reactivity X 4) Acute systemic toxicity test X 5) Hemocompability test X 6) Ethylene oxide (EO) sterilization re-siduals (if using EO to sterilize)X XNOT
42、E Testing is done in accordance with the ISO 10993 series.5.2 Performance requirements5.2.1 Resisting negative pressureResisting negative pressure of the cupping device shall not be less than the maximum instantaneous pressure of 91,50 kPa. See A.2.5.2.2 Pressure maintenancePressure loss between the
43、 body of cupping device and skin shall not be less than 10 % of its maximum pressure for 10 min. See A.3.4 ISO 2017 All rights reservedBS ISO 19611:2017ISO 19611:2017(E)5.2.3 Mechanical stabilityRegarding the performance of the cupping device when resisting pressure, pressure shall be maintained aft
44、er the impact at a force of 0,5 J 0,05 J using a universal spring hammer. See A.4.5.2.4 TransparencyThe body of the cupping device shall be sufficiently transparent to observe and distinguish the changes of skin colour. See A.5.5.2.5 Repeated disinfection resistanceMultiple-use cupping device shall
45、not exhibit changes in performance after repeated disinfection. See A.6.5.3 Sterilization and disinfection5.3.1 Sterilization for single-use type devicesSingle-use type devices shall be sterilized using a validated sterilization procedure that shall comply with ISO 11135, ISO 11137-1 or ISO 17665-1.
46、5.3.2 Disinfection for multiple-use type devicesMultiple-use type devices shall be disinfected using a validated disinfection procedure that shall comply with ISO 17664 see 7.3 g).6 Package6.1 Primary packageThe cupping device shall be sealed in a primary package. There shall be no foreign matter wi
47、thin the primary package under visual inspection.The material and design of this primary package shall not have detrimental effects on the contents. The material and design of this primary package should be such as to ensurea) the maintenance of sterility and disinfection of the contents under dry,
48、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, andd) that once opened, the package cannot be easily resealed, and it shall be o
49、bvious that the package has been opened.Requirements of materials, sterile barrier systems and packaging systems for terminally sterilized medical devices are provided in ISO 11607-1.6.2 Secondary packageOne or more primary packages shall be packaged in a secondary package. The secondary package shall be sufficiently robust to protect the contents during handling, transport and storage. One or more secondary packages may be packaged in storage and/or a transit package. ISO 2017 All rig
