INTERNATIONAL iso STANDARD 8655-1 Fst etion ang i Piston-operated volumetric apparatus — Part 1 Terminology, general requirements and user recommendations ‘Appareils volumétriques @ piston — Partie 1: Defnitons, exigonces générales et reeemmendations pour Putisatour Reference numbor Iso 8688120020) 180 2002180 8655-1:2002(€) Ts POF tema contain ade pelea. aeereanc wih Adc’ cesing ply hse maybe eta ot ened but shallot be ed ues ihe ypc er ar unde oo eansed and stald on be camer ptm ihe wing, nooo a bares secp teint esponsiiyortnhiait ADD ening potcy Th SO Canal Seen septa Moloney nthe ee ‘ets cl he sate pods ad ort 8 POF fl an a oun th Gano ela heh; he POF croton seams were orice png, Ear eae os b0en ake to rai a > a sl fr vy 150 memear dla eke hea ae ats pcan lr € ound. soseinary be Cart Secret avalbesdsersghen been © 02002 is weed Unies: sherpa no pr of the pubicoton ey reproduced ee wed ony biome by ay ee “lectonk r metanes rckudng ghotwenpyni and mitt, thot permtan a tn om miter 90 MO asc oF SOG Inortar Goayn te onan se 130 copii oice Geet SeCh2H Gea Fae 1419890987 Exmot coprgin@icnch (6180 2002 gms eserad| | Contents Scope Normative references, “Terms and defintions a Types of piston-operated volumetic apparatus General requirements and testing Product information Marking Annex A. List of equivalent terms Bibliography, Factors affecting choice of piston-operated volumetric apparatus... 1S0 a655-1:2002(€) Paso 1 1 2 4 5 5 6 7| 180 8655-1:2002(€) Foreword International Standards are drafted im accordance wth the rules given inthe ISOMEC: Directives, Par 3. Pracmtnatonal Standaes adopted by the technical eammitees are eculted tothe member bodies fr voting Frutiicaton as an Intemational Standard requis approval by atleast 75 % ofthe member bodies casings von ‘Atention is drawn to the possibilty that some af the elements ofthis part of SO B65 may be the subject of patent ‘ighis. 180 shall not be held responsible for ideniying any oral such patent rights, International Standard {SO 8655-1 was prepared by Technical Committee ISQITC 48, Laboratory glassware and ‘ated apparatus, Subcommilee SC 1, Volimctic struments $80 8555 consists a ho following parts, under the goneral tie Pston-operated velimotic apparatus — Port 1: Terminotoay, general requirements and user recommendations — Part 2: Piston pinetios = Part 3: Piston burettes — Port 4: oitutors — Part & Dispensers ~ Part 6: Gravimetric methods fr the determination of measurement error The folowing paris under preparation: — Part 7: Non-gravimetre methods forthe dotormination of meesurement error ‘Annex A forms a normative part a his part of ISO 8085,et ON ERE ERR 180 8655-1:2002(E) Introduction 180 8656 addresses the needs of — supplicrs, as basis for quality contra! incuding, whore appropriate, the issuance of supplier's declarations — test houses and other bodies, as a basis for independent certiteation; — Users ofthe equipment, to enable routine checking of accuracy. The tests specified should be carried out by tained porsonnel 1180 2002- Arg essaiii tata at INTERNATIONAL STANDARD 180 8685-1:2002(€) Piston-operated volumetric apparatus — Part 4: Terminology, general requirements and user recommendations 1 Scope ‘This part of ISO 8655 species the general requirements fr piston-oporatad volume apparatus. applicable to piston ppetes, piston burottes, cor and dispenses. I thermore defines terms for he use of poker eee volumeire apparatus and gives user recommentations '80 8655 is not appiable to medical product intended er uso on human beings, efor medical syringes. NOTE |For metoogiarearements, maxinnin pormisible eres, requis lr marking and inrmation obo provided ior HSB or ston-operated vokimatc apparatus, sce 180 8655-2 fr piston ction, see ISO BEBB) lor pola Sen, 150 88554 for ultors and see 150 8655 for dpensors. Conform lacing (9p evaluation) of panies en poarats‘a gen in 180 8055-3. Atoratve teat mathods such 98 phatometnc a simatic elNinis ol or he aoe ea {uuu Pat 10 860. Fr oboe et (og cay aasrance byt mippar, hate ond measur eee eee assurance bythe user su 190 8855.6 oraternlineemehoos 2 Normative references The flowing normative dacuments conan provisions which, through reference in this ext, conettule provisions of this part of $0 8855. For dated references, subsequent amendments to, or revisions o, sry of ses publicnien ce ot apply: However, parties to agreements basad on tis part of 180 8655 are encouraged lo ancsinte tee Bossibity f applying the most recent ediions ofthe normative documents Indicated below, for unaareseot nce the latst alton ofthe normative document refered to apples. Members of 1SO and IEC mainamn roqitors of ccurrenly vale Intemational Standards 'S0 9685-2:2002, Piston-operated volumetric apparatus — Part 2: Piston pipettes 'S0 9655-9:2002, Piston operated volumetric apparatus — Part 3: Piston burettes 'S0 8658-1:2002, Piston-operated volumetric apparatus — Part 4: Diltors $80 8658-5:2002, Paton-operated votimetrc apparatus — Part 5: Dispensers 180 8855-6:2002, Asian operated volumetic apparatus — Fert 8: Ciraumotne methods lor me determunenon or ‘measurement error EC 6007S, Basie and safety principles for man-machine terface, marking and idenilcaion — Coding principles for Inaication dovieas ana actuators IEC 61010-1, Safety roquroments for electical equipment fr measurement, contol and laboratory use — Part 4 Goneral requirements TEC 61926-1, Electrical equinment for moasurement, control and aboratary use — EMC requirements 12150 2002 Anh sere 4Iso 9655-1:2002(6) 3. Terms and definitions For the purposes ofthis part of ISO 8655, the felowing rms and defitons apply 3.4, Motrolegical terms, aaa ‘maximum permissible error TERE et Betmited extreme value forthe deviation of tha dsponsed volume fiom the nominal okie 3.1.8) or selecled volume (3.1.6) ofa piston-operaled wolametne apparali, NOTE. general detiniton fr maximum peinissibleerori gen nthe Vin COTE, me merine permissible err of pstr-cperaed vlunette appr are specie ISO 8655-2 to 180 86555. Conformity testing fer obsorvanceof maximum permis erarsisperaran grauimeticaly aceon in oe eee 3a2 systematic orror {Piten-oparatod velumetic apparalus) diferance belweon the dispansed volume ang tne nominal volume or Selecied volume of he piston-operated volumetric apparatus NOTE 1. Genraldfnitons fr systematic eor ate given in he VM and ISO 3634-1 NOTE Fat contami tosing in accordance with 190 96556. the systamatic aris asoortined ty taking the mean of 10 mossurements 343 random error ston-operated votumettie apparatus) seater of the dispensed volumes around the meon ofthe disponsod vohynes [NOTE 1 Gonorldetintions for random err are given in the VIN an ISO 634-4 Norra dtasetamiy tena in secordonce wih 150 8685-4, te random arcs aeoerane by Ying He oputoity Sandra doriaion of 10 veasucinan, 3a8 Uncertainty of measurement {Yolume dispensed by a piston-operated apparatus) parameter, associated wth the dispensed volume, that characterizes the dapersin ofthe vokunos that could reasonably he albiuted to te depend woken, NOTE 1 Adopted tor the Vid NOTE 2 The uncertainty of measuroment comprises portions ofthe systematic and random eitr of moaburemeot. The aleuaton of the ancorainty of measurement carbo poremod i the equation shin amex Bat 00 aoe eee 348 nominal volume (Pistor-operates volumetric apparatus) volume speciiod by the manufacturer and usod far Montiication and for indication ofthe measunng range NOTE For specie piston persed velumatleopparais such a8 vavate-rume piston pipettes and mut channel piston Prpetos tis defntion i frthorquaitein the appcta pats of GO oes 316 { salected volume \Yariable-volume volumevic apparatus) volume sat by Une user, in ordero dispenge a volume chosen from the useful volume range (3.1.7) of @variabla-volume piston-oparated volumes spparaies NOTE Fer tneutume piston operated vetumer¢ apparatus, the soci volume is equal tothe nina volume — i | ma 180 2000 —Atighis rsd /at = ISO 8655-1:2002(E) 3a7 Useful volume range that part of the nominal volume which allows dispensing under absorvanee of the maximum permissible errors as pected in the applicable part af ISO 685, NOTE i The upper tm of he useulwowme Htnototnorise species by the suppl. ina! voli, Tho Yawar i 10 % ofthe nominate 9 is aay NOTE 2 For pistonoperated buets, povéion may be made inthe design for tho bute to be recharged automaticaly (iwotung mare than ane stoke othe piston) belo ho raqurad volume as boon disper, volume {piston-operated pipettes with air interface) ar voluma between the lower part ofthe piston and the surface of the quia 319 ‘dead liquid volume {positive isplacomont pipattes, huretes, lunes and dispensers) amount of quid which does not belong to the Sispensed volume and which is contained during operation in aspiration er expoling tubes, valves ang wis the eylinder aa.t0 adjustment {pion operated volumetric apparatus) manutacturo of an apporalue within appropriate tolerances, ortho supplier's Seitng of ihe apparatus, ensuing the metrological porformance, 3s specified in tne applicable part of {SO 8685, fr #9 relorenea temperature of 20°C oat User adjustment {piston-operated pipette) adjustmant employing only the means al the dispasal ofthe user NOTE 1 Ape om the Vi NOTE 2 Asjusmentraqures operations which mociy the appara fr subsnguent measurements aaaz celibration (iston-operated volumetric apparatus) set of operations that establish the relationship between the dispensed volume and the coresponcing nominal or selected volume of ie apparatus NOTE 1 Adaptod em tha Vi NOTE 2. The result of a calibration geems the determination of eonrection vals o ‘exparded unoertanty 2, falpwing an achustnent or user acjstmn| i dispensed vatume ands sesocatod NOTES Tho roBut ofa calibration maybe recorded i a document cad a callraton cerca oa ealration eon NOTE 4 Calibration requires ro operation which pormaneny mods the apparatus 3.2 Terms related to testing 324 conformity testing {piston-oporated volumetric apparatus) systematic examination to determine whether the requirements specified in this imernational Standard, especialy in 2 matological senso, ae fullitrs NOTE 1 Adapted tom ISOMEC Guide 2 NOTE 2 The corresponding ist methods ave spocfelin the apace par of SO 855. (61802072 ~ A git reserve 3180 8655-1:2002(6) 3.2.2 ‘ype testing ‘conformity testing on the basis of one or more specimens of a product representative of the production 323 arty that i eesponsible forthe piston-operated volumotic apparatus and is able fo ensure thal quay assurance is exercised NOTE This dofiniion may apply o manwasturers stibutr, importers, assomblrs, sowie aranizations 324 supplies declaration document by which a supplier gives written assurance that a piston-operated valumliic apparatus conforms tothe requirements ofthis International Stance [NOTE The supplier's dactraton can be issu for eontrmity testing, 325 ertieate of conformity ocumenl issued under the rules of a certicalion system, providing confidence thal conformity testing has been Berfarmed and thatthe piston-operated volumelic apparatus fails Ihe requirements spaciied in ths internaticnga Standard NOTE 1 Aduplod ttm ISONEC Gui 2 NOTE 2. Cartcaes of confermiy fer pislon-operatadvlumete apparatus ce alvays rlalod tothe enti eysem incing ‘mevoiogtealy leant accesses Fortis tedson certates of early for plpeke tip ane fr tures Sone en ‘ndieate embinations of pston-opeaed volumelic apparaia an actessunes or ch he sation ees 3.26 calibration certifeste document issued atfer he calibration ofa piston-oporated valumelie apparatus, reporting the resi of calibration 4 Types of piston-operated volumetric apparatus 4.4 General Piston-oporated volumetric apparatus includes a range of devices intended lo asptate or diver speci vokumos of liguics: ey may be manually or automatically operated and are controled by mechanical, electro mechaniea! slactanio means. 4.2 Piston pipettes Piston-operated pipetles are used to pick up and delvor liquids, Singlo-channal piston pipettes have anly one pstonylinder assembly. Muitzehanne piston pipellos havo a pstondcyinder assembly for each channel, tne aarve ‘wolume of gad can be delivered into several receptacles simallanieausly (for exanise the walls of 9 mictlle plate, Piston-operated pipotos may be factory-presel la deliver a given volume, or may have ser-seluctoble vouos within a useful volume range, Piston-operated pipettes may be of he positive diplacement or ai-displacoment type (see 1S0 8655-2), 43 Piston burettes Piston burelias are designed to deliver liquid progressively unt the volume delivered is suticient 0 satisty extemal {usually analytical coria such as change of colour, pH, canductiviy or polarzation, The volume Selvercd may be ‘ad ftom o display or recorded trom the apparatus by other means (sea ISO 8655-3). 4 1150 2002 Aig served1S0 8855-1:2002(c) 44 Dilutors, Bre Scent caer micluros of luis of dofned volumcile proportions, The intended volumes of sample Spr tuliion Mid chosen to provide a eambined volume ofthe required dition fli, are dear aelecies pros he rane at Selvery of he quids. According to ISO 8655-4, diutors may be construed with or without feos a may be ot ix or vanaie volume, 4.5. Dispensers provanser ot used forthe repative delvery (sisponsng) of a measured volume of fqul.Singl-siokedspensers a sate delvory from each fling soko. Muliple defvery igpansois Or tachelbmeed Helge ce ‘hukiple deliveries om each filing sake, 5. General requirements and testing Pstorroperatd volumetric apparatisshall conform othe appropriate raqirementsof tho folowing specications, — Electrical and goneral satoty requirements, in accordance with IEC 61010-1 — Electromagnatie compatibility requiroments, in occordance with IEC 61326-1 — The marking and layoul of electronic csplays, meters and contol in ascardance with IEC 60073, © Product information BA Us information Uiucioas fo uso shallbe packaged with each piston-operated volumetic apparalus, The insructlons shal include ‘least the feloaing user information ®) Tha conlants ofthe apparolus package shal be listed including accessories, Ifthe pleton-operated volume: Spyies canne! properly be usu as divered, dete inrmatien concerning the seated cocoa oe ‘ania rocomimendation as te where ia aequite them shal by nckadon O eeeatee latmation on the slaiizalion of the pistonoperated volumetric apparatus oF ts ports, including SGeRabe steiization mecia such as sizam, hot ar, ethylne oxic), seriizaion temperature (eceh an soon Fee iad lining conaitions (2g. maximum recortmented pressure for autoclaving) shallba gen ahol k made clear wither and to whal exon the piston-operated wolumelnic apparaln shall te domes ce seriization tno such information i included inthe user information, then the piston-operated vokimetrie apparatus shallbo understood not tobe steriizable, ©) Intvucions for care, cleaning and maintenance of he pslon-aperaladvokumatic apparatus shal be given © Faotagambimum formation for individual aparetus types (seo clause 4) a8 specified inthe applicable parts of 180 8658 shall be given ©), The temperature range in which the piston-operated volumetiic apparatus can be used shall be given 62 Decontamination {ihe supplier shall wpon request, indicate how the plston-operated volumetric apparatus can bo dismantled for fitter crconteminaton in case i used in canjuncon wih radoacive, of chemtaly or meeboloceay tazardous substances. The decontamination is placed under the responsibly of the veer Pace nes volumotric apparatus shall not be sent to iid parties iil is not Gecontaraten (2180 2002 - Aight reseed 5Iso 8655-1:2002(E) 6.3 Chemical resistance Tag, sulle shal, upon request, provide information regarding the chemical resistance of the piston-opeatod volumetric apparatus against organic anc inorganis solutions ond soon 7. Factors affecting choice of piston-operated volumetric apparatus 7.1. Interaction with iquids ‘without measuradly altering the metrologial performance of tho apparetoa [The user should verily thatthe piston-operated volumeiic apparatus is resistant tothe liquid tha iti Intended to ‘measure, and thal no Gontaminaton of th aus thos place. Tis canbe accomplshed, fr exatph, Sy rtorner resistance tables or, ¥ necessary, by undertaking tests onthe apparatus and ihe lquid im ueslon: Rote ae 6.1 0),6.2 and 6.3. 7.2 Use of piston pipettes with air interface In order 10 achieve the mast accurale mesaurements, the user should note and obsorve the insliuetions for uso igre bythe manuincturer. Special care shal be taken to avoid Held being agiroted ino the meri verre the pipete, {Aimer B in 150 8659-2:2002 provides comprehensive information on possible sources of enor and how to avoid thor, ‘Tins made of past for pston pipettes with ac interface are designed fr singlo use. They should not be cleaned for ‘rouse as their metrological characteristics can na longer be roee, 7.3. Testing by the user Users should establish acceptable maximum permissite systematic and random errors based on tho fd of use and the accuracy requirements placed on the plslon-operaied volumetric ayparciug The confermity lo the accoptable maximum permissible errors shal be tested by iho users at regula inervals as part of tne 19 oF analytical qualiy control routines, for example every threw manths tet t Teese (once a year Other time intervals may be speeibed by the users depending upon — toqueney of use, — number of users ofthe piston-operated volumetvic apparatus, — aggressive nature of th liquid to be delivered, and — aocepiable maximum permissible erors estaiished by the user. Testing can Le done gravimetrically in accordance with ISO 8655-For by ether methods. NOTE Atoratve test methods sueh as phoometc and ivimeti metheds wil be specie nth future Part 7 0 ISO B68, [When testing following maintenance or repai, the maximum permissible errors established inthe applicable part of 180 8655 apaly. 6 1180 2002 ips essen8 Marking Marking Iso 88 9 of tho individual piston-operated volumetric 59-3, 80 B655-$ oF ISO 8655.5, as appropriate, 180 8655-1:2002(6) ‘pparatus shall be done in accordance with ISO 8655.2,180 8885-1:2002(E) Annex A (normative) List of equivalent terms Fagin Fone Seaman Fach iain jomisbearar* —[Enaarmainam ate Flloseoe Salt via arse HON # me Ereur(nmesua) ——esstwoicung [ane [acraey 5 ect mr coor [Trueneas BE ustesse | Rietnigke’ Pikeman Precision = ne Passion Fosotonns —— Systematic error 9% Erreur systématique eee a [arjestetmatinen viene ass Ener avinaiewe (Sarat conn wom ator lEveurmeatone utange [ssimnacane | som “ ee oo feesony str aevton®<[Ewtynecorrsanne [RHR Neca [Uncestainty of measuremani*®* incevttude de mesure [Messunsicherhok Mitauiksen epavarncas Penner [siege Lens sana | Calibration = [Etalonnage [Kalibrierung [Katibroint [Verification [Eichung [ermisies _| ekonomi Tennis Talia ian Ts kexts oa eset meg one dewiime ——‘|ruzvouen Rex carrer [er doe st [Uoeitonpang ~~ ~~leany or 1 Supper Fourisseur [able i 8 12180 2002-1 rsa4 1S0 8655-1:2002(6) Bibliography {1} 180 3594-1, Statistics — Vocabulary and symbols — Part 1: Prababilty and goneral statistical arms 2) 1805725-1, Accuracy (rueness and provision) of measurement mathods and results — Part t: General principles and definitions IB] 180 100121, Quality assurance requirements for moasuring equipment — Part 1: Molrological contimation system for measuring equipment [4] ISDNEC Guide 2, Stondevaization and related acvities — General vocaburary [51 Ioternatonet vocabulary of basic and genera rms in mowology (VIM), BIPM, IEC, IFCC, ISO, NPAC, INPAP snd OW, 1993 IB) OIA. R 76-1:1992, Non-aufomatic weighing instruments — Part 1: Metrlogical and technical requirements (6180 2002 ~ At Hos aera ®Ics 01,040.17; 17.060ty ICONTEC Po 1) 667 ea rae) 222135, ‘Eat ogstsmennucarsce sannavous Pex (5 30 86 acon) ceo sm berongagseonse ag co voit Hom, 48490 Pox (cat o12uror Gy 51 rat! exec Cate Bt nett Ca 202 Tease (6329825 fo 3808 ‘Emat Sustanengedieecrsc enon 0 Ne 989t x e312 0900 Foe 3180278 mak egotngesrator.o Fe somes re eee ET a Glen SO Cos Conde ere Gb) 17 680 ma coerce