© ISO 2016 Dentistry — Powered scaler Médecine bucco dentaire — Instruments pour le détartrage INTERNATIONAL STANDARD ISO 18397 First edition 2016 01 15 Reference number ISO 18397 2016(E) ISO 18397 20[.]
INTERNATIONAL STANDARD ISO 18397 First edition 01 6-01 -1 Dentistry — Powered scaler Médecin e bucco-den taire — In strum en ts pour le détartrage Reference number ISO 83 97: 01 6(E) © ISO 01 ISO 183 97:2 016(E) COPYRIGHT PROTECTED DOCUMENT © ISO 2016, Published in Switzerland All rights reserved Unless otherwise speci fied, 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 intranet, without prior written permission Permission can be requested from either ISO at the address below or ISO’s member body in the country of the requester ISO copyright office Ch de Blandonnet • CP 401 CH-1214 Vernier, Geneva, Switzerland Tel +41 22 749 01 11 Fax +41 22 749 09 47 copyright@iso.org www.iso.org ii © ISO 2016 – All rights reserved ISO 183 97:2 016(E) Contents Foreword Page Introduction Scope Normative references vi Terms and definitions Classification of scaler handpieces Requirements and performance v 1 3 G e n e ral M ate ri al s D ro p te s t N o i s e l eve l 5 S u rface s 5.6 5.7 5.8 5.9 Electrical power supply (if applicable) Energy for light source (if applicable) Air supply Supply of cooling liquid Ai r an d wate r p re s s u re 1 Te m p e ratu re 1 Te m p e ratu re ri s e o f h o u s i n g 1 Te m p e ratu re , exce s s ive 5 Vi b rati o n s 5 Re s i s tan ce to re p ro ce s s i n g 5 Le akage an d /o r i n gre s s o f wate r 5 O p e rati n g co n tro l s 5 C o n n e cti o n 5.15 5.17 Electromagnetic compatibility Usability G e n e ral 8.2 C o n n e cti o n s fo r r- p o we re d s cal e r h an d p i e ce s 8.3 C o n n e cto r fo r e l e ctri cal - p o we re d s cal e r h an d p i e ce s S cal e r ti p p e rfo rm an ce 5.19.2 5.19.3 5.19.4 5.19.5 5 8.1 9.1 5.20 S cal e r ti p co n n e cti o n Extraction force (for non-screw tips only) Holding torque (for screw-in-tips only) Insertion force (for non-screw-tips only) Tightening torque (for screw-in-tips only) 9.6 S tal l e ffo rt 9.7 Po we r o u u t, s cal e r ti p s 9.8 B re akage re s i s tan ce Frequency Am p l i tu d e Sampling Testing 7.1 G e n e ral te s t co n d i ti o n s 7.2 Vi s u al i n s p e cti o n 7.3 7.4 7.5 Power supply — Electrical Air supply Ap p aratu s P ro ce d u re 7.5 Ap p aratu s 7.5 P ro ce d u re Supply of cooling liquid © I S O – Al l ri gh ts re s e rve d iii ISO 183 97:2 016(E) 7.6 7.6.1 Apparatus 7.6.2 Procedure 7.7 Measuring device for dimensions 7.8 Scaler tips 7.9 7.1 7.1 Air and water pressure 7.8.1 7.8.2 7.8.3 7.8.4 Extraction force (for non-screw-tips only) Holding torque (for screw-in-tips only) Insertion force (for non-screw-tips only) Tightening torque (for screw-in-tips only) 7.8.5 Stall effort 7.8.6 Power output, scaler tips 7.8.7 Breakage resistance 7.9.1 Apparatus 7.9.2 Procedure Frequency Amplitude 7.1 0.1 Apparatus 7.1 0.2 Procedure Noise level 7.1 1 Apparatus 7.1 Test conditions 7.1 Procedure 7.1 Temperature rise of housing 7.1 Temperature, excessive 7.1 Resistance to reprocessing Instructions for use, maintenance and service 14 Technical description 10 15 Marking 15 0.1 General 0.2 Scaler handpieces 0.3 Scaler tips 11 Labelling 16 12 Packaging 16 Annex A (informative) Calculation example for power output 17 iv © ISO 01 – All rights reserved ISO 183 97:2 016(E) Foreword ISO (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 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 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 In particular the different approval criteria needed 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 (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 patent rights identi fied 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 For an explanation on the meaning of ISO speci fic terms and expressions related to conformity assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information The committee responsible for this document is ISO/TC 106, instruments Dentistry, Subcommittee SC 4, Dental This first edition of ISO 18397 cancels and replaces ISO 15606:1999 and ISO 22374:2005, which have been technically revised © ISO 01 – All rights reserved v ISO 183 97:2 016(E) Introduction Dental scaler handpieces and scaler tips have been used in dental treatment procedures for many years A s te c h n ic a l de ve lo p me n t h a s re s u l te d i n i mp ro ve d s c a le r h a n dp i e c e s a nd tip s , th i s re v i s e d I n te r n atio n a l Standard is necessary to ensure the level of safety and performance, both of the individual devices and i n c o mb i n atio n , i s at a n ap p ro p r i ate le ve l vi © I S O – Al l ri gh ts re s e rve d INTERNATIONAL STANDARD ISO 183 97:2 016(E) Dentistry — Powered scaler Scope This International Standard speci fies requirements and test methods for air-powered and electricalpowered scaler handpieces and scaler tips, including piezo, ferrostrictive and magnetostrictive type u l tra s o n i c s c a le r s , o p e rate d as s t a n d- a lo ne i te m s or c o n ne c te d to de n ta l u n i ts , fo r use on p ati e n ts It also contains speci fications on manufacturers’ instructions, marking and packaging Normative references The 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, the latest edition of the referenced document (including any amendments) applies I S O 19 42 , D en tistry — Vo ca b u la ry I S O -1 , Mech a n ica l vib tio n — Mea su rem en t a n d e va lu a tio n o f h u m a n exp o su re to h a n d-tra n sm itted vib tio n — Pa rt : Gen era l requ irem en ts I S O -2 , Mech a n ica l vib tio n — Mea su rem en t a n d e va lu a tio n o f h u m a n exp o su re to h a n d- tra n sm itted vib tio n — Pa rt 2: Pra ctica l g u ida n ce f o r m ea su rem en t a t th e wo rkp la ce I S O 74 -1 , D en tistry — D en ta l u n its — Pa rt : Gen era l req u irem en ts a n d te st m eth o ds I S O , D en tistry — Ho se co n n ecto rs f o r a ir driven den ta l h a n dp ieces I S O 7, D en ta l eq u ip m en t — Gra p h ica l s ym b o ls f o r den ta l eq u ip m en t ISO 9 -1 , Bio lo gica l e va lu a tio n o f m edica l de vice s — Pa rt 1: Eva lu a tio n an d te stin g with in a risk m a n a g em en t p ro cess I S O 14 45 7, D en tistry — Ha n dp ieces a n d m o to rs I S O 2 -1 , Medica l de vice s — Sym b o ls to b e u sed with m edica l de vice la b els, la b ellin g a n d in f o rm a tio n to b e su p p lied — ISO 76 , p ro ce ssin g Pa rt : Gen era l req u irem en ts Steriliza tio n o f m edica l de vices — In f o rm a tio n to be p ro vided by th e m an uf a ctu rer f or th e o f re steriliza b le m edica l de vice s I S O , Gra p h ica l s ym b o ls f o r den ta l in stru m en ts IEC 6 -1 , e s se n tia l Me dica l e le c trica l e q u ip m e n t — Pa rt 1: Ge n e l re q u ire m e n ts f or b a s ic sa f e ty an d p e rf o rm a n ce I E C 6 1-1-2 , Medica l electrica l equ ip m en t — Pa rt -2: Gen era l req u irem en ts f o r b a sic sa f ety a n d e ssen tia l p erf o rm a n ce — I E C 61 67 -1 , Co lla tera l Sta n da rd: Electro m a g n etic distu rb a n ce s — Requ irem en ts a n d te sts Electroacoustics — Sound level meters — Part 1: Specifications I E C 62 6 -1 , Medica l de vice s — Pa rt : A p p lica tio n o f u sa b ility en gin eerin g to m edica l de vice s I E C 1-2 - : 2 , Medica l electrica l eq u ip m en t — Pa rt 2- 60: Pa rticu la r requ irem en ts f o r b a sic sa f ety a n d e ssen tia l p erf o rm a n ce o f den ta l eq u ip m en t © I S O – Al l ri gh ts re s e rve d ISO 183 97:2 016(E) 3 Terms and definitions For the purposes of this document, the terms and de finitions given in ISO 1942, ISO 14457 and the following apply powered scaler scaler powered by air or electrical energy air-powered scaler handpiece powered by pressurized air, with an oscillating working part 3.3 electrical-powered scaler handpiece powered by electrical energy, with an oscillating working part operating area of scaler tip area of the working part for use as described by the manufacturer scaler handpiece p o we re d h a nd he l d h a ndp ie c e u s e d to o p e rate a n o s c i l l ati n g o r re c ip ro c ati n g wo rki n g p a r t scaler tip fixed or interchangeable instrument used in an air-powered or in an electrical-powered scaler h a ndp i e c e a nd c o n s i s ti n g o f a s h a n k a n d a wo rki n g p a r t Key wo rki n g e n d tran s m i s s i o n p art s h an k wo rki n g p art Figure — Designation of parts for scaler tips transmission part tool designed to transmit energy from the shank to the working end Note to entry: See Fi g u re working end distal end of an oscillating instrument intended for direct use in the oral cavity of the patient Note to entry: See Fi g u re © I S O – Al l ri gh ts re s e rve d ISO 183 97:2 016(E) working part part of a fixed or interchangeable instrument connected to a scaler handpiece Note to entry: See Fi g u re 10 shank p a r t o f a n o s c i l l ati n g i n s tr u me nt c o n ne c te d to a s c a le r h a ndp i e ce Note to entry: See Figure 4 Classification of scaler handpieces Scaler handpieces are classi fied according to the frequency of the scaler tips into two types as given in Tab le Table — Frequency of scaler tips Type Energy supply A i r p o we r e d E l e c tr i c a l p o we r e d Frequency 000 Hz < frequency ≤ 40 000 Hz 18 000 Hz < frequency ≤ 60 000 Hz Requirements and performance 5.1 General T he c o n s tr uc ti o n o f h a ndp ie ce s s h a l l b e s a fe a nd p ro vi de re l i ab l e o p e ratio n T he s e re qu i re me n ts shall b e c o mp l i a n t w i th I E C 62 6 -1 If field-repairable, the handpieces shall be capable of being easily disassembled and reassembled for maintenance and repair utilizing either readily available tools or special tools supplied by the m a nu fac tu re r Electrical requirements are only applicable to electrically powered handpieces and handpieces with light supply 5.2 Materials Materials used for parts of scaler handpieces or scaler tips that are likely to get in contact with the p r ac ti tio ne r o r the p atie n t s h a l l b e b i o co mp ati b le Test for biocompatibility shall be in accordance with ISO 10993-1 5.3 Drop test Te s t fo r s c a l e r h a ndp ie ce s w i tho u t ti p s s h a l l b e i n acco rd a nc e w i th I E C 6 1-1 NO TE 5.4 I n I E C 6 1-1 : 0 , , the te s t p r o c e du r e i s s ta te d Noise level A-weighted sound pressure level by the scaler handpieces shall not exceed 80 dB(A) Te s t i n acco rd a nc e w i th 1 © I S O – Al l ri gh ts re s e rve d ISO 183 97:2 016(E) 5.5 Surfaces Particular attention should be given to providing secure gripping surfaces for operator manipulation under normal use conditions Test in accordance with IEC 62366-1 In order to reduce glare, highly polished surfaces should be avoided 5.6 Electrical power supply (if applicable) The requirements shall be speci fied by the manufacturer and shall comply with ISO 7494-1 Test in accordance with 7.3 5.7 Energy for light source (if applicable) The requirements of the light source shall be speci fied by the manufacturer and shall comply with ISO 7494-1 Test in accordance with 7.3 5.8 Air supply Air-powered handpieces shall be operated by a pressurized air supply in accordance with the manufacturer’s instructions The necessary flow rate shall be