BS ISO 18746-2016 Traditional Chinese medicine Sterile intradermal acupuncture needles for single use《传统中医药 一次性无菌针灸针》.pdf

1、BS ISO 18746:2016Traditional Chinese medicine Sterile intradermal acupunctureneedles for single useBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS ISO 18746:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 18746:2016.The

2、UK participation in its preparation was entrusted to TechnicalCommittee CH/100, Healthcare and Medical Equipment.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. Us

3、ers are responsible for its correctapplication. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 82852 2ICS 11.040.25Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of

4、theStandards Policy and Strategy Committee on 31 August 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS ISO 18746:2016 ISO 2016Traditional Chinese medicine Sterile intradermal acupuncture needles for single useMdecine traditionnelle chinoise Aiguilles dacupuncture i

5、ntradermiques striles usage uniqueINTERNATIONAL STANDARDISO18746First edition2016-08-15Reference numberISO 18746:2016(E)BS ISO 18746:2016ISO 18746:2016(E)ii ISO 2016 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2016, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no

6、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 an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member

7、 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.orgwww.iso.orgBS ISO 18746:2016ISO 18746:2016(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and defini

8、tions . 14 Structure and dimension of intradermal acupuncture needles . 24.1 Size designation . 24.2 Structure and dimension of intradermal granule type needle 34.2.1 Structure of intradermal granule type needle 34.2.2 Dimension of intradermal granule type needle 34.3 Structure and dimension of intr

9、adermal thumbtack type needle 44.3.1 Structure of intradermal thumbtack type needle 44.3.2 Dimension of intradermal thumbtack type needle 45 Materials . 55.1 General . 55.2 Body of intradermal acupuncture needle 56 Performance requirements . 56.1 Appearance and cleanliness 56.2 Drawing strength 56.3

10、 Hardness of the needle body . 66.4 Intensity and puncture performance of the needle tip 66.5 Sterility 67 Packing and identification . 67.1 Primary packaging . 67.1.1 Packing method 67.1.2 Identification . 67.2 Secondary packaging . 77.2.1 Packing method 77.2.2 Identification . 7Bibliography 8 ISO

11、2016 All rights reserved iiiContents PageBS ISO 18746:2016ISO 18746:2016(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 te

12、chnical 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 close

13、ly 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 ne

14、eded 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

15、 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

16、 this document is information given for the convenience of users 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 World Trade Organization (WTO) principl

17、es in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.The committee responsible for this document is ISO/TC 249, Traditional Chinese medicine.iv ISO 2016 All rights reservedBS ISO 18746:2016ISO 18746:2016(E)IntroductionAs one of several different needling a

18、pproaches, intradermal acupuncture needles are recognized as an effective treatment for various disorders. Intradermal acupuncture needles are easy to use and especially effective when relatively long-lasting stimulation to a needling site is needed. Therefore, safety and sanitation considerations o

19、f intradermal acupuncture needles should be more carefully reviewed as well as their compatibility to human body.As a biomaterial, acupuncture needles can be corrosive and have potential to lose some of their mechanical characteristics. Furthermore, leachable substances can affect human tissue in an

20、y unintended, yet potentially harmful way. To address this problem, biomaterials should have no toxicity or produce any adverse effects, and should have appropriate mechanical characteristics such as tensile strength, elasticity, durability of abrasion and fatigue strength. In addition, the material

21、 should have a strong corrosion resistantability.This International Standard establishes an international standard for intradermal acupuncture needles. The characteristics of intradermal acupuncture needles include size, material, quality, tests, packing and identification through regulating marking

22、 methods. The standardization of the characteristics of intradermal acupuncture needles has potential to enhance the efficacy and improve the quality and safety of acupuncture treatments using intradermal acupuncture needles especially in regard to the biocompatibility for human body. ISO 2016 All r

23、ights reserved vBS ISO 18746:2016BS ISO 18746:2016Traditional Chinese medicine Sterile intradermal acupuncture needles for single use1 ScopeThis International Standard specifies the requirements of sterile intradermal acupuncture needle for single use as a medical device, including the following fac

24、tors:a) size;b) material;c) quality;d) testing methods;e) packing;f) identification.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 und

25、ated references, the 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 10993-7, Biological evaluation of medical devices Part 7: Ethylene oxide steriliz

26、ation residualsISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirementsISO 17218:2014, Sterile acupuncture needles for single use3 Terms and definitionsFor the purposes of this document, the following terms and

27、definitions apply.3.1intradermal acupuncture needlessmall needling instrument for embedding in the skinNote 1 to entry: There are two types of intradermal acupuncture needles. One is termed an intradermal thumbtack type needle and the other is intradermal granule type needle.SOURCE: WHO Internationa

28、l Standard Terminologies on Traditional Medicine in the Western Pacific Region, 5.1.29, modified Note 1 to entry has been added.3.2intradermal granule type needleintradermal acupuncture needle inserted obliquely or horizontally into subcutaneous tissue often across various sites on the human bodyINT

29、ERNATIONAL STANDARD ISO 18746:2016(E) ISO 2016 All rights reserved 1BS ISO 18746:2016ISO 18746:2016(E)3.3intradermal thumbtack type needleintradermal acupuncture needle resembling a thumbtackSOURCE: WHO International Standard Terminologies on Traditional Medicine in the Western Pacific Region, 5.1.2

30、83.4body of the needlepart of the intradermal acupuncture needle that is inserted into the human bodySOURCE: ISO 17218:2014, 3.1, modified3.5handle of the needlepart of the intradermal acupuncture needle that is not inserted into the human body and is often used to manipulate the needle during inser

31、tionSOURCE: ISO 17218:2014, 3.2, modified3.6tip of the needlesharp apex at the end of the acupuncture needle body that is inserted into the human bodySOURCE: ISO 17218:2014, 3.33.7primary packagesealed or closed packaging system that forms a microbial barrier, directly enclosing the acupuncture need

32、leSOURCE: ISO 17218:2014, 3.93.8secondary packagepackage containing one or more primary packages for transportation and storageSOURCE: ISO 17218:2014, 3.10, modified4 Structure and dimension of intradermal acupuncture needles4.1 Size designationThe size of the body of the needle shall be designated

33、by the following:a) the nominal diameter of the body of the needle (or when no body of the needle, the maximum diameter of the tip of the needle), expressed in millimetres;b) the nominal length of the body of the needle, expressed in millimetres.The size shall be referred to as “the designated metri

34、c size” and specified as a) b).EXAMPLE 0,16 mm 10 mm.2 ISO 2016 All rights reservedBS ISO 18746:2016ISO 18746:2016(E)4.2 Structure and dimension of intradermal granule type needle4.2.1 Structure of intradermal granule type needleThe intradermal granule type needle shall have the structure as shown i

35、n Figure 1 and be composed of the body of the needle, the handle of the needle and the tape (in some cases). The type of needle handles are not limited to those shown in Figure 1.Key1 handle of the needle d1diameter of body of the needle2 body of the needle L1length of handle of the needle3 tip of t

36、he needle L2length of body of the needleFigure 1 Example of typical structure of intradermal granule type needle4.2.2 Dimension of intradermal granule type needleThe nominal diameter of body of the needle and the length of body and handle of the needle shall be measured using a gauge specified in Ta

37、ble 1 (see Figure 1).Table 1 Nominal dimension of intradermal granule type needlePartNominal dimen-sions mmToleranceThe body of the needleNominal diameter d1d 0,40 10 %Nominal length L2L2 5 0,55 L2 10 0,810 L2 30 1,0The handle of the needleNominal length L11,6 L1 ISO 2016 All rights reserved 3BS ISO

38、 18746:2016ISO 18746:2016(E)4.3 Structure and dimension of intradermal thumbtack type needle4.3.1 Structure of intradermal thumbtack type needleThe intradermal thumbtack type needle shall have the structure as shown in Figure 2 and be composed of the body of the needle, the handle of the needle and

39、the tape (in some cases). The type of needle handles are not limited to those shown in Figure 2.Key1 handle of the needle d1diameter of body of the needle2 body of the needle L1length of handle of the needle3 tip of the needle L2length of body of the needleFigure 2 Example of typical structure of in

40、tradermal thumbtack type needle4.3.2 Dimension of intradermal thumbtack type needleThe nominal diameter and the length of the body of the needle, and the nominal length and the diameter of the handle of the needle shall be measured using a gauge specified in Table 2 (see Figure 2).Table 2 Nominal di

41、mension of intradermal thumbtack type needlePartNominal dimen-sions mmToleranceThe body of the needleNominal diameter d1d1 0,40 10 %Nominal length L2L2 3 0,53 L2 5 0,85 L2 30 1,0The handle of the needleNominal length L12 L14 ISO 2016 All rights reservedBS ISO 18746:2016ISO 18746:2016(E)5 Materials5.

42、1 GeneralThe biocompatibility of the body of the needle, the tape and the coating shall be assessed and documented according to the guidance and principles given in ISO 10993-1.Compliance is demonstrated bya) analogy with published data,b) the selection of materials already shown to be biocompatible

43、 by proven 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 the acupuncture needle, ord) compliance with published procedures for biological evaluation of medical devices.If the material of

44、the body of the needle or tape is changed and/or if there is a new coating applied to the surface of the needle body, and if there is risk that the new material or coating may cause adverse side effects to human tissue, then testing should be conducted in accordance with ISO 10993 series.5.2 Body of

45、 intradermal acupuncture needleThere is no uniform regulation regarding materials of the needle handle and body. Currently, the most popular material for the needle body consists of X5CrNi189, X7CrNi189 Austenite Stainless Steel, etc., which are listed in ISO 15510.6 Performance requirements6.1 Appe

46、arance and cleanlinessWhen observed under a microscope of low magnifications (10), the intradermal acupuncture needle shall not have roughness, grooves, rust, twist and/or bending. When observed under a microscope of medium or high magnifications (20 or higher), the tip of the needle shall not have

47、scars, foreign matters, broken or stumpy parts, bending, peeling surface coat and residual substances such as various solvents as used, fine metal particles which may be created in the process of cutting and grinding.6.2 Drawing strengthThe body of the needle shall be solidly joined to the handle of

48、 the needle.When the minimum static force given in Table 3 is applied in the direction of the centre axis of the body of the needle depending on the length of the body of the needle, it shall not be drawn out of the handle of the needle.Table 3 Force to test drawing strengthNomnial length of needle

49、body, L2mmForce NL2 2 1,52 L2 5 35 L2 30 5 ISO 2016 All rights reserved 5BS ISO 18746:2016ISO 18746:2016(E)6.3 Hardness of the needle bodyApply ISO 17218:2014, 5.3.3.6.4 Intensity and puncture performance of the needle tipApply ISO 17218:2014, 5.3.5.6.5 SterilityThe sterile intradermal acupuncture needle shall be sterilized through a validated sterilization process in order to ensure that the products are sterile.In case of using ethylene oxide gas, testing for the residu