BS ISO 18666-2015 Traditional Chinese medicine General requirements of moxibustion devices《中国传统医学 灸法设备的通用要求》.pdf

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1、BSI Standards PublicationBS ISO 18666:2015Traditional Chinese medicine General requirements ofmoxibustion devicesBS ISO 18666:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 18666:2015.The UK participation in its preparation was entrusted to TechnicalCommi

2、ttee CH/100, Healthcare and medical equipment (Europeanand International).A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctappl

3、ication. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 82632 0ICS 11.040.99Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Commit

4、tee on 30 November 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS ISO 18666:2015 ISO 2015Traditional Chinese medicine General requirements of moxibustion devicesMdecine traditionnelle chinoise Exigences gnrales concernant les dispositifs de moxibustionINTERNATIONAL

5、 STANDARDISO18666First edition2015-11-01Reference numberISO 18666:2015(E)BS ISO 18666:2015ISO 18666:2015(E)ii ISO 2015 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2015, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or u

6、tilized otherwise in any form or by any means, electronic or mechanical, including photocopying, 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 copyr

7、ight officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 18666:2015ISO 18666:2015(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Configuration . 24.1 Structure . 24.

8、1.1 Size and shape 24.1.2 Visual inspection 24.2 Expression of dimensions 25 Materials . 35.1 General . 35.2 Body of moxibustion devices 35.3 Moxibustion materials 35.3.1 Moxa floss. 35.3.2 Moxa sticks 36 Moxibustion temperature . 46.1 General . 46.2 Moxibustion with tube . 46.3 Moxibustion devices

9、other than moxibustion with tube 46.4 Moxibustion devices for repeated use 47 Safety requirements . 47.1 General . 47.2 Environmental protection . 48 Packaging . 48.1 Primary packaging . 48.2 Secondary packaging . 59 Labelling 59.1 Primary label 59.2 Secondary label 510 Transport and storage 511 Ins

10、tructions for use (to be provided by the manufacturer) 6Annex A (informative) Test methods to determine the moxibustion temperature . 7Annex B (informative) Method of artificial drying of mugwort leaves by heat .10Bibliography .11 ISO 2015 All rights reserved iiiContents PageBS ISO 18666:2015ISO 186

11、66:2015(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. Each member body interested in a subject for

12、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 al

13、l 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. Th

14、is 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 o

15、r 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 user

16、s and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementar

17、y informationThe committee responsible for this document is ISO/TC 249, Traditional Chinese medicine.iv ISO 2015 All rights reservedBS ISO 18666:2015ISO 18666:2015(E)IntroductionThis International Standard specifies the general requirements for safety and quality of moxibustion devices, including th

18、e moxibustion materials used in such devices. The safety and quality of both moxibustion devices and materials are closely related to moxibustion safety and quality.There is a wide variety of moxibustion devices and materials currently available commercially, but there are no standards guiding their

19、 manufacture and finishing. Increased interest and use of moxibustion, as well as growing patients expectations and concerns regarding moxibustion safety and quality, have given rise to the need to improve safety and quality of moxibustion through implementation of an International Standard.The prim

20、ary aim of this International Standard is to ensure the safety and quality of moxibustion devices and materials.Annex A gives guidance on the methods that can be used to determine the moxibustion temperature at the human body surface during treatment using the moxibustion device.Annex B gives guidan

21、ce on the method of artificial drying of mugwort leaves by heat. ISO 2015 All rights reserved vBS ISO 18666:2015BS ISO 18666:2015Traditional Chinese medicine General requirements of moxibustion devices1 ScopeThis International Standard specifies the general requirements for configuration, materials,

22、 performance and safety requirements of moxibustion devices. It also specifies the minimum requirements for moxibustion materials used in moxibustion devices.It is applicable across a wide range of moxibustion devices that uses moxa floss as the main combustion material and can remain on or over the

23、 body throughout the moxibustion process. It is applicable to moxibustion devices for both single and repeated usage.This International Standard does not apply to devices that imitate moxibustion, such as electro-moxibustion and infrared moxibustion devices that do not involve the use of moxa floss.

24、 It also does not apply to moxa floss used in direct moxibustion.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, th

25、e 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 processISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to

26、 be supplied Part 1: General requirementsISO/TS 10993-19, Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1moxibustio

27、n deviceapparatus that uses moxa floss as the main combustion material and intended for single or repeated usageEXAMPLE Moxibustion with tube is a type of moxibustion device, such as a short moxa roll with a cardboard base and a moxa tube (made of cardboard) that is single-use and developed as an al

28、ternative to direct moxibustion.Note 1 to entry: Moxibustion device includes those accessories as defined by the manufacturers that are necessary to enable the normal use of the moxibuston device.3.2moxibustion materialcombustible material comprising mainly moxa floss and used in moxibustion3.3body

29、of moxibustion devicepart of the moxibustion device that is used to hold moxibustion materials and remains on or over the human body throughout the moxibustion processINTERNATIONAL STANDARD ISO 18666:2015(E) ISO 2015 All rights reserved 1BS ISO 18666:2015ISO 18666:2015(E)3.4moxibustion temperaturete

30、mperature at the human body surface during treatment when using the moxibustion device3.5moxa flosscotton-like material for moxibustion made from mugwort leaves3.6moxa stickround long stick made of moxa floss, also called moxa rollNote 1 to entry: Moxa sticks can be in the form of a pure moxa stick,

31、 medicinal moxa stick (with additives) or smokeless moxa stick.3.7medicinal moxa stickmoxibustion with the moxa roll made of moxa and various substances3.8fineness of moxa flossweight of the starting material (mugwort leaves) to the weight of the final product (moxa floss) presented in the form of a

32、 ratio4 Configuration4.1 Structure4.1.1 Size and shapeThe sizes and shapes of moxibustion devices can be different to perform moxibustion at a single point or over an area of the human body surface.4.1.2 Visual inspectionWhen inspected by normal or corrected-to-normal vision:a) the surface of the mo

33、xibustion device shall not have any obvious defects such as breakages, protrusions, dents or rust that could cause accidental cuts or injuries to the user;b) moxibustion devices for repeated use shall have a temperature-adjusting mechanism or other appropriate arrangement to maintain moxibustion at

34、an appropriate temperature;c) except for moxibustion with tube, the body of the moxibustion device shall ensure that the removal of ash is easy, be well ventilated to facilitate combustion and it should also contain the following:1) a mounting base or support that can hold the stick (s) firmly;2) a

35、barrier or other safety arrangement to prevent ash or ember from falling onto the surface of the human body.4.2 Expression of dimensionsThe moxibustion device shall be easy to manipulate in size and applicable to various parts of human body. The dimensions of the moxibustion device shall be expresse

36、d in centimetres and specified as length breadth height for a rectangular shaped device, or diameter height for a circular shaped device.EXAMPLE 1 For a rectangular device, 15 cm 10 cm 8 cm.2 ISO 2015 All rights reservedBS ISO 18666:2015ISO 18666:2015(E)EXAMPLE 2 For a circular shaped device, 4 cm 6

37、 cm.5 Materials5.1 GeneralThe materials of the moxibustion device in contact with the human body surface shall be assessed for their biological safety and physico-chemical, morphological and topographical (PMT) characteristics in accordance with ISO 10993-1 and ISO/TS 10993-19.5.2 Body of moxibustio

38、n devicesThe frame of moxibustion devices can be made of materials such as wood, plastic, metal or cardboard. It shall have properties of low flammability and be fire retardant to prevent fire hazards from occurring in moxibustion. The materials of the component of the moxibustion device that comes

39、in contact with the human body surface shall have low thermal conductivity and shall not cause skin sensitivity or irritation.5.3 Moxibustion materials5.3.1 Moxa floss5.3.1.1 Moxa floss shall be processed from mugwort leaves of the Artemisia genus, including Artemisia argyi, Artemisia princeps, Arte

40、misia vulgaris and other Artemisia species that have proven to be equally suitable.5.3.1.2 Moxa leaves shall be stored under a dry and well-ventilated environment for at least 1 year or stored for 3 months and be artificially dried by heating before processing into moxa floss.5.3.1.3 The minimum fin

41、eness of moxa floss should be in the ratio of 3:1, where 3 kg of mugwort leaves is processed into 1 kg of moxa floss.5.3.1.4 Moxa floss shall not contain any foreign matter, such as metal shavings, which may contaminate the moxa floss during production and processing.5.3.1.5 The quality and safety o

42、f moxa floss can be determined by visual or physical inspection and the use of other inspection equipment such as a metal detector.5.3.2 Moxa sticks5.3.2.1 The external wrapping used for moxa sticks made using moxa floss shall be material manufactured from mulberry leaves or other combustible paper.

43、5.3.2.2 The external wrapping used for moxa sticks made using moxa floss shall meet the following requirements:a) to have a similar burning rate as moxa floss;b) not to emit any harmful substances during combustion;c) not be torn easily.5.3.2.3 The adhesive material used in moxa sticks shall not be

44、toxic or produce harmful substances during combustion. ISO 2015 All rights reserved 3BS ISO 18666:2015ISO 18666:2015(E)6 Moxibustion temperature6.1 GeneralThe test methods to determine the moxibustion temperature are stated in Annex A.6.2 Moxibustion with tubeThe maximum temperature shall not exceed

45、 60 C.6.3 Moxibustion devices other than moxibustion with tubeExcept for moxibustion with tube, the moxibustion temperature of the moxibustion device shall be adjustable and the maximum temperature achievable during use of the device shall not exceed 51 C.6.4 Moxibustion devices for repeated useFor

46、moxibustion devices for repeated use, there shall be a temperature-adjusting mechanism to maintain the temperature under the users thermal pain threshold.7 Safety requirements7.1 General7.1.1 Moxibustion devices for repeated use shall have a barrier or other safety arrangement to prevent any ash, em

47、ber or spark from falling onto the human body surface.7.1.2 The body of the moxibustion device shall be able to remain on or over the human body surface in a stable manner throughout the moxibustion process to prevent the device from falling over or being dislodged.7.1.3 The materials of the part of

48、 moxibustion devices that come in contact with the human body surface shall have poor thermal conductivity to ensure the temperature is within the acceptance limits of the moxibustion recipient.7.1.4 Moxibustion devices that remain on the human body surface shall be either for single use or repeated

49、 use. For repeated use, they shall have a disposable bottom or protective lining on the areas that come in contact with the human body surface to prevent any form of direct-contact infection or transmission.7.2 Environmental protectionNecessary measures that can protect the environment shall be identified and employed. Moxibustion devices can include a protective installation, use better quality moxa floss or have additives added to the moxa floss to reduce the amount of smoke.8 Packaging8.1 Primary packaging8.1.1 Moxibustion