BS ISO 17218-2014 Sterile acupuncture needles for single use《一次性无菌针灸针》.pdf

1、BSI Standards PublicationBS ISO 17218:2014Sterile acupuncture needles forsingle useBS ISO 17218:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 17218:2014. The UK participation in its preparation was entrusted to TechnicalCommittee CH/100, Healthcare and m

2、edical equipment (European and International).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 Stan

3、dards Institution 2014.Published by BSI Standards Limited 2014ISBN 978 0 580 78013 4ICS 11.040.25Compliance 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 May 2014.Amen

4、dments/corrigenda issued since publicationDate T e x t a f f e c t e dBS ISO 17218:2014 ISO 2014Sterile acupuncture needles for single useAiguilles dacupuncture striles usage uniqueINTERNATIONAL STANDARDISO17218First edition2014-02-01Reference numberISO 17218:2014(E)BS ISO 17218:2014ISO 17218:2014(E

5、)ii ISO 2014 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2014All 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 an in

6、tranet, 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 officeCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgPublish

7、ed in SwitzerlandBS ISO 17218:2014ISO 17218:2014(E) ISO 2014 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Configuration . 24.1 Acupuncture needle configuration 24.2 Acupuncture needle types . 24.3 Types of needle handles

8、 35 Requirements 55.1 Materials . 55.2 Dimensions . 55.3 Performance requirements 75.4 Sterility assurance 96 Package . 96.1 Primary package 96.2 Secondary package . 107 Labelling .107.1 General 107.2 Primary package . 107.3 Secondary package . 108 Transit and storage .11Annex A (informative) Test m

9、ethods for the intensity and sharpness of the tip of the needle 12Annex B (informative) Test methods for the puncture performance of the tip of the needle16Annex C (informative) Test method for resistance to corrosion .21Bibliography .23BS ISO 17218:2014ISO 17218:2014(E)ForewordISO (the Internationa

10、l 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 technical committee has been es

11、tablished 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 electrotechnical standardi

12、zation.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 drafted in accordance w

13、ith 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 rights. Details of any

14、 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 constitute an endorsement.

15、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 - Supplementary informationThe committee responsible fo

16、r this document is ISO/TC 249, Traditional Chinese medicine.iv ISO 2014 All rights reservedBS ISO 17218:2014ISO 17218:2014(E)IntroductionThis International Standard applies to sterile acupuncture needles for single use (specialized for filiform needles) used by professional acupuncturists for acupun

17、cture treatment. Sterile acupuncture needles for single use are sterilized by the manufacturer, and the healthcare professional can open the sealed package and use the needle immediately.In order to encourage innovation, this International Standard does not enforce the combination of the needle diam

18、eter and length. However, considering the clinical usage requirements, the standard provides the specifications for the needle diameter and length.The sharpness and puncture performance of the needle tip are of very important clinical significance. Annex A states the guidelines and the evaluation me

19、thods for the intensity and the sharpness of the needle tip, while Annex B provides two qualitative and quantitative evaluation methods to determine the puncture performance of the needle tip.The qualitative methods to evaluate the puncture performance of needle tip are described in Annex B. The met

20、hods are simple, direct and practical. It makes them especially suitable for routine inspection and for cross-comparison of the acupuncture needles clinical applications. They also play a very important role in the enhancement of the quality of the needle tip. The methods to evaluate the puncture pe

21、rformance of the needle tip can be used to further evaluate the puncture and puncture performance of the acupuncture needle. Currently, the more appropriate method is to use the needle tip to pierce through polyurethane material; however, this method has not yet been implemented internationally.Cons

22、idering the consistency of standards in the future, this standard provides the methods to evaluate the puncture performance of the needle tip and ranks 5.3.5.2 as recommended. The standard does not provide the sharpness index of the piercing through polyurethane material by the needle tip. This inde

23、x will be added to the standard when it becomes appropriate. To improve product quality, all inspection reports should include the inspection information as well as the results of the performance evaluation.Since every manufacturers design, production, and sterilization methods are different, no reg

24、ulations exist for the materials of the acupuncture needle handle. Still, the needle body and the needle handle of acupuncture needle should have good biocompatibility. In order to ensure product safety and efficacy, the manufacturer should perform risk analysis and enforce risk management in additi

25、on to adhering to the requirements of local rules and regulations, the relevant background data of the medical devices and clinical practice throughout the entire duration of the products life cycle. ISO 14971 has provided manufacturers a framework for the effective management of hazards associated

26、with the use of medical devices.In some countries, the requirements proposed here are subject to legal sanctions. Such rules and regulations should take precedence over the standards set forth in this document. ISO 2014 All rights reserved vBS ISO 17218:2014BS ISO 17218:2014Sterile acupuncture needl

27、es for single use1 ScopeThis International Standard specifies the requirements for the sterile acupuncture needles for single use (specialized for filiform needles).2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable f

28、or its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 6507-1:2005, Metallic materials Vickers hardness test Part 1: Test methodISO 10993-1, Biological evaluation of medica

29、l 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 be supplied Part 1: General requirements3 Terms and definitionsFor the purposes of this document, the following terms and

30、definitions apply.3.1body of the needlepart of the acupuncture needle that is inserted into the human bodyNote 1 to entry: See Figure 1.3.2handle of the needlepart of the acupuncture needle that is not inserted into the human bodyNote 1 to entry: See Figure 1.3.3tip of the needlesharp apex at the en

31、d of the acupuncture needle body that is inserted into the human bodyNote 1 to entry: See Figure 1.3.4root of the needlepart of the acupuncture needle that connects the needle body to the needle handleNote 1 to entry: See Figure 1.3.5tail of the needleend part of the needle handle at the opposite si

32、de of the tip of the needleNote 1 to entry: See Figure 1.INTERNATIONAL STANDARD ISO 17218:2014(E) ISO 2014 All rights reserved 1BS ISO 17218:2014ISO 17218:2014(E)3.6sterile acupuncture needleacupuncture needle that has been sterilized3.7guide tubeassistant tool in the shape of a slender, long tube i

33、nto which the needle is placed and used for easy insertion3.8hardness of the needle bodymeasure of resistance of the acupuncture needle body to permanent deformation3.9primary packagesealed or closed packaging system that forms a microbial barrier, directly enclosing the acupuncture needleNote 1 to

34、entry: The primary package is usually the smallest unit package of use and the package that is in direct contact with one or more acupuncture needles.3.10secondary packagepackage containing one or more primary packages for distribution and storage4 Configuration4.1 Acupuncture needle configurationTh

35、e configuration of the acupuncture needle and the name of each of its parts are shown in Figure 1.Key1 tip of the needle2 body of the needle3 root of the needle4 handle of the needle5 tail of the needleFigure 1 Example of typical structure of acupuncture needle4.2 Acupuncture needle typesThe acupunc

36、ture needle includes two types: acupuncture needle with a guide tube; and acupuncture needle without a guide tube.The acupuncture needle with guide tube is shown in Figure 2. However, no uniform requirement is provided for the fixing method of the needle tube.2 ISO 2014 All rights reservedBS ISO 172

37、18:2014ISO 17218:2014(E)Key1 guide tubeFigure 2 The acupuncture needle with a guide tube4.3 Types of needle handlesThe types of needle handles include the ring handle, the plain handle, the flower handle, the metal tube handle, and the plastic handle, etc. The types of needle handles are not limited

38、 to those shown in the Figure 3. ISO 2014 All rights reserved 3BS ISO 17218:2014ISO 17218:2014(E)Key1 ring handle l1length of the needle body2 plain handle l2length of the needle handle3 flower handle d diameter of the needle body4 metal tube handle5 plastic handleFigure 3 Example of types of handle

39、s of acupuncture needles4 ISO 2014 All rights reservedBS ISO 17218:2014ISO 17218:2014(E)5 Requirements5.1 MaterialsThe biocompatibility of the body of the needle shall be assessed and documented according to the guidance and principles given in ISO 10993-1.Compliance is demonstrated by:a) analogy wi

40、th published data; orb) the selection of materials already shown to be biocompatible by proven 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 acupuncture needle; ord) compliance wit

41、h published procedures for biological evaluation of:1) Cytotoxicity;2) Sensitization;3) Intracutaneous reactivity;4) Ethylene oxide sterilization residuals (if using EO. to sterilize).If the material of the body of the needle is changed and/or if there is a new coating on the surface of the needle b

42、ody, and if there is risk indicating that these may cause side-effects to the human body, then testing should be in accordance with ISO 10993 series.NOTE There is no uniform regulation regarding materials of the needle handle and body. Currently, the popularly used material of the needle body is mad

43、e of X5CrNil89, X7CrNil89 Austenite Stainless Steel, etc. which are given in ISO 15510:2010.5.2 Dimensions5.2.1 Size designationThe size of the acupuncture needle shall be designated by the following:a) the nominal diameter of the body of acupuncture needle, expressed in millimetres; andb) the nomin

44、al length of the body of acupuncture needle, expressed in millimetres.The size of acupuncture needle shall be referred to as “the designated metric size” and specified as the diameter of the needle body the length of the needle body.EXAMPLE 0,30 40 mm5.2.2 Tolerance of dimensions5.2.2.1 Diameter of

45、the needle bodyWhen measured by a micrometer or similar equipment, the nominal diameter of the body of acupuncture needle shall comply with Table 1. ISO 2014 All rights reserved 5BS ISO 17218:2014ISO 17218:2014(E)Table 1 Nominal diameter of needle bodyDimensions in millimetresNominal diameter of nee

46、dle body dTolerance0,10 d 0,25 0,0080,25 d 0,45 0,0150,45 d 0,80 0,0205.2.2.2 Length of body of the needleWhen measured by vernier calipers or similar equipment, the nominal length of the body of acupuncture needle shall comply with Table 2.Table 2 Nominal length of needle bodyDimensions in millimet

47、resNominal length of needle body l1Tolerance5 l1 25 0,5025 l1 60 1,0060 l1 100 2,00100 l1 200 3,005.2.3 Dimensions of needle handleThe handle of acupuncture needles shall be of suitable diameter and length for the intended purpose or manipulation.The length of the handle of acupuncture needles (l2)

48、shall be no less than 13 mm.The dimensions of the coiling handle wire used in the manufacturing of ring handles, plain handles and flower handles should comply with Table 3. The diameter of the plastic handle and the metal tube handle should comply with Table 4.Table 3 Diameter of the coiling handle

49、 wireDimensions in millimetresNominal diameter of needle body dDiameter of the coiling handle wire0,10 d 0,20 0,300,20 d 0,30 0,350,30 d 0,40 0,400,40 d 0,50 0,450,50 d 0,80 0,506 ISO 2014 All rights reservedBS ISO 17218:2014ISO 17218:2014(E)Table 4 Diameter of the plastic handle and the metal tube handle and coiling handle which are joined by other method than coiling around the needle bodyDimensions in millimetresType of needle handle Diameter of needle handleMetal tube ha