(cid:40)(cid:91)(cid:75)(cid:76)(cid:69)(cid:76)(cid:87)(cid:3)200(cid:22)(cid:3)
`A™ 2AR008B
`
`

`

`Waters Techs. Corp. v. Biomedical Device Consultants & Labs
`IPR2018-00498
`Ex. 2003
`
`Page 1 of 128
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`

`

`Objectives and uses of AAMI standards and
`recommendedpractices
`
`It is most important that the objectives and potential uses of an
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`understood. The objectives of AAMI's technical development
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`medical instrumentation. Essential to such advancement are (1) a
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`technologies. It is AAMI's view that standards and recommended
`practices can contribute significantly to the advancement of
`medical
`instrumentation, provided that
`they are drafted with
`attention to these objectives and provided that arbitrary and
`restrictive uses are avoided.
`A voluntary standard for a medical device recommendsto the
`manufacturer the information that should be provided with or on
`the product, basic safety and performancecriteria that should be
`considered in qualifying the device for clinical use, and the
`measurement techniques that can be used to determine whether the
`device conforms with the safety and performancecriteria and/or to
`compare the performance characteristics of different products.
`Somestandards emphasize the information that should be provided
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`for use, warnings and precautions, and other data considered
`important in ensuring the safe and effective use of the device in the
`clinical
`environment.
`Recommending
`the
`disclosure
`of
`performance characteristics often necessitates the development of
`specialized test methods to facilitate uniformity in reporting;
`reaching consensus on these tests can represent a considerable part
`of committee work. When a drafting committee determines that
`clinical concerns warrant the establishment of minimum safety and
`performancecriteria, referee tests must be provided and the reasons
`for establishing the criteria must be documentedin therationale.
`A recommendedpractice provides guidelines for the use,care,
`and/or processing of a medical device or system. A recommended
`practice does not address device performance per se, but rather
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`safely and effectively and that its performancewill be maintained.
`Although a device standard is primarily directed to the
`manufacturer, it may also be of value to the potential purchaser or
`user of the device as a frame of reference for device evaluation.
`Similarly, even though a recommendedpractice is usually oriented
`towards healthcare professionals,
`it may be useful
`to the
`manufacturer in better understanding the environment in which a
`medical device will be used. Also, some recommended practices,
`while not
`addressing device performance
`criteria, provide
`guidelines to industrial personnel on such subjects as sterilization
`processing, methods of collecting data to establish safety and
`efficacy, human engineering, and other processing or evaluation
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`such guidelines may be useful
`to health care
`professionals in understanding industrial practices.
`In determining whether an AAMIstandard or recommended
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`document, several important concepts must be recognized:
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`is
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`Single user license provided to AAMI standards committee members.
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`recommendations embodied in a standard or recommended practice
`are intended to respond to clinical needs and, ultimately, to help
`ensure patient safety. A standard or recommended practice is
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`in the sense that
`it
`responds generally to
`perceived risks and conditions that may not always be relevant to
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`important reference in responsible decision-making, but it should
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`Despite periodic review and revision (at least once every five
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`take into account
`the specifics ofits
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`INTERPRETATIONS OF AAMI STANDARDS
`AND RECOMMENDED PRACTICES
`
`Requests for interpretations of AAMIstandards and recommended
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`

`

`American National Standard
`
`ANSI/AAMI/ISO 5840-3:2013
`
`Cardiovascular implants — Cardiac valve prostheses
`— Part 3: Heart valve substitutes implanted by
`transcatheter techniques
`
`Approved 23 November 2012 by
`Association for the Advancement of Medical Instrumentation
`
`Approved 4 December 2012 by
`American National StandardsInstitute
`
`Abstract:
`
`Outlines an approach for verifying/validating the design and manufacture of a transcatheter heart
`valve substitute through risk management. The selection of appropriate verification/validation tests
`and methods are to be derived from the risk assessment. The tests may include those to assess
`the physical, chemical, biological and mechanical properties of heart valve substitutes and of their
`materials and components. The tests can also include those for preclinical in vivo evaluation and
`clinical evaluation of the finished heart valve substitute.
`
`Keywords:
`
`design, hydrodynamic, material, performance,preclinical, risk, verification, structural
`
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`
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`AAMI website at www.aami.org..
`
`All AAMI standards, recommended practices, technical information reports, and other types of technical documents
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`user of the document. Occasionally, voluntary technical documents are adopted by government regulatory agencies
`or procurement authorities,
`in which case the adopting agency is responsible for enforcement of its rules and
`regulations.
`
`Published by
`
`Association for the Advancement of Medical Instrumentation
`4301 N. Fairfax Drive, Suite 301
`Arlington, VA 22203-1633
`Www.aami.org.
`
`© 2013 by the Association for the Advancementof Medical Instrumentation
`
`All Rights Reserved
`
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`
`Printed in the United States of America
`
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`
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`

`

`Contents
`
`Page
`
`PPPOE Se ETERS ESTE EE RESTS CORRee
`
`vi
`
`Glossary of equivalent standards........ccsssessseseens
`prereset errrretire
`
`Committee representation........ccccceee
`eee eee EEEEE
`
`Background........00
`
`. Vii
`SO0SSE SESE CEE EEC E ETERS REESE REESE SESE eee eee
`
`vii
`
`SO0000000
`
`FOr@WONsisiiaisninpanistacnsegaeinsedcnecuucevwveesdianiarad
`senaerdedureuanieuapeseacsecsesnasodanpensqhsausnsadsatensansntasuessusersdsantararsaratiarasiansnianas
`
`INtrOGUCTION .......cccceseeeeteeseesesetensnnees
`$0000 S0 0S FOSSEEE
`
`igakaninvidkjeajuniniaddananianhiaantaisvaded dvaeiniaisbeandsiansamansiera
`
`anal
`
`won X
`
`1 2 3
`
`4
`
`5
`
`7
`
`7.1
`7.2
`7.2.1
`7.2.2
`7.2.3
`7.2.4
`7.2.5
`7.2.6
`7.2.7
`7.2.8
`7.2.9
`7.2.10
`7.3
`7.3.1
`7.3.2
`7.3.3
`7.4
`7.4.1
`7.4.2
`7.4.3
`7.44
`7.4.5
`7.4.6
`
`Scope......
`
`Normative references ......000000
`
`Abbreviations .......::cccsceserceccseeeet
`
`PASSESEE eeee
`
`Terms and definitions..........csssssssecaetes
`siniiphhdphastgnianieeteanduatdentTesdeswedeabiqjodedidcennengeiaascnbcasenusyaalaaidianiasaiynbe
`
`3
`
`11
`
`nha
`inphtinaciieaarmeiiais
`
`aviddavsbdniseiniaripessiacsbeaypaptapecpeainnsendbbadenihidajdidujehinaaadsanaspamisvavupetardnin
`
`APS00 FS FSS RSRSE R eRe
`
`11
`11
`
`12
`13
`
`
`
`Risk management........+
`
`iniatenredeeesiGhebowiae etampayinnaen
`
`General requirement...ss.ssscscsseescsssseesserensnseseeseenesenses
`aeneee
`In vitro assessment...
`mipieieesoene
`
`15
`15
`joc15
`oe eEeEeee
`15
`
`16
`
`santaecetatseuanseeannsndananaccseestesesnsnannstssesreee
`
`pinasaARbeOTNEPEREOciiSRPTANITELUNEhderinebeieesmanreddeas
`
`aienvavivvaetapatieiast A
`Fundamental requirements .....0.cccsscscsssesceeseesecssiscesesereeseeesnenses
`i POSE CSET EFC USESEERE ESESESEee
`Device description ......cc-sesccccnceseracsesnesetes
`6
`APOC SOOSES
`Intended USE .......sccccsceeeceenseseeee
`6.1
`O00 06 FONEe OeREE
`Design inputs..........
`6.2
`O0E0e COs SHEER ESE ESET ESSE SEEeee
`6.2.1 Operational specifications.........ccccseseeeees
`5000000000CSS
`6.2.2.
`Performancespecifications...........
`AoPe eRe ee CACCee ee
`6.2.3.
`Implant procedure...
`6.2.4
`Packaging, labeling and sterilization.
`2500 COS EETEERE REESE REEEE
`a aeeeee
`6.3
`Design outputs........0.000008
`Designtransfer (manufacturing verification/validation)..
`apagcaeaaadiaminiuetdppsiapawtabawiktadint
`6.4
`6.5
`Design verification ee and analysis/design validation...........cccccscseescsseeseeensnecneenarnes
`16
`Test conditions, samplesolaation andreportingrequirements...
`wiedieioasendpawidienianiadcteeubiians
`16
`seanteenens
`Material property assessment..
`apuisdenrou
`Device hydrodynamic perfomance, assessment..
`18
`.. 20
`Structural performance asseSSmMent........:ceecerees
`Additional implant design evaluation requirementssnaseunsadundebnidnedsebssdsathinsasdesntubattaniessrennanets
`22
`DOC
`23
`Delivery system design evaluation requirement......ccseseeerees
`24
`Design-specific testing .......ssscssssesessnees
`25
`Visibility ....
`sdeebeeee nee 2RRR Eee eee
`25
`Simulated use..
`Human factors/usability assessment,hiispincas
`25
`Porro
`25
`Preclinical in vivo evaluation...
`ap 25
`Overall requirements.......0s00000«
`SPSS PSOEEEE
`27
`Methods .......cccsccnscres
`28
`Test rePOrt srersserersecsensersesecnsessssntsnsasenasserane
`29
`Clinical investigations.........cccs00
`2600S SOTEa
`29
`General..
`Statisticalconsiderations. seicinaveniocdetanad
`end
`29
`Distribution ofaonand investigators...shane
`30
`PITT eee rereeetrereeri)
`exeree 30
`Sample SiZe.........ccesceee
`FUeEROSS ESSERE REE eeee eee eeeee ee eee ne
`00006 CUE SeeEEEREee
`30
`Entry criteria....
`200000Se
`30
`Duration of the Study ........scccccseseerarenees
`
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`Page 5 of 128
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`

`

`7.4.7
`7.4.8
`
`Clinical data requirements...........:ccssssseecesesossesessoceseressecesersesseaeseetssssssssussssausssessnsnscssesescesarsaren O14
`Clinical investigation rePOrt...cssusscssscssssesssessesnseseseesssesessessesersererserersetenssasassasasssssnarasvavassssassnsees OO
`
`Annexes
`
`Annex A (informative) Rationale for the provisions of this part Of ISO 5840 ....csssssserssssrssserrserenses OD
`
`AnnexB(informative) Examples of transcatheter heart valve substitutes, components and
`Aelivery SySteMS ...:siscivianidsniisinomoinaradimsainntavasansaecciczocacnesnpasieiupiaiaviaideinidvipaidaneiaaismlainnsiavaaniaal SO
`
`Annex C (normative) Packaging.......ssessssscrsssenserssssssesstssneeseesnseasessseaseesescoseeseesessassatsetassessssesessessssssers 44
`
`Annex D (normative) Productlabels, instructions for use and training ......c.ccccseceseecesereeeseseeseneeeeee 45
`
`Annex E (normative) Sterilization.......cccccccscssesecsssessessesssenssssssessssuseesasesseesssesassassassuvascesessossssssssarsersnsees 49
`
`Annex F (informative) Valve description .......:sssssssssserssessessssesseensessnetseesseessssseessseesessscessassnerassaneareereee 5O
`
`Annex G (informative) Transcatheter heart valve substitute hazards, associatedfailure
`MOdes ard evaluation Method .....ccssssssseseesensssssssssseasesescssssesssssscesseseesasrsscetesesserersssceseesees OZ
`
`Annex H (informative) In vitro test guidelines for paediatric AeVICES......:.0ssssssersstencesensecesorensensensane DT
`
`Annex I (informative) Statistical procedures when using performance Criteria.......c.cscsesssscssersees 62
`
`Annex J (informative) Examples and definitions of some physical and material properties of
`transcatheter heart valve substitutes and their components.........:s0+s0+seressrescssssreersntencenenes OD
`
`Annex K (informative) Examples of standards applicable to testing of materials and
`componentsof transcatheter heart valve substitutes ............cccccsessssessssesesssssseesssesssseeeeesnnes 78
`
`Annex L (informative) Raw and post-conditioning mechanical properties for support
`Structure materials pesssvssegumaiancessccascclwandanviweisheisaseiseacieucvadaiidelarabebisdsatnmeu tiendate 85
`
`Annex M (informative) Corrosion aSSeSSMENt.....ss0sssssssssssssessssesasacsssarassceatsesseseseseesnsnnensesensvavscnsnacas OF
`
`Annex N (informative) Guidelines for verification of hydrodynamic performance...90
`Annex O (informative) Durability testing ......c.c..cccccccscsssscssesssssssscsserssssesessessssssssssssrsesoncnsonsscssassnsersesees 94
`
`Annex P (informative) Fatigue asSeSSMent.......:.:.sssscscecssssestenssssensnesssecstensssasenseessssneerencessrsacencessseneees 96
`
`Annex Q (informative) Preclinical in vivo evaluation........:.escssssoecsecsesessetsacesssseserssrsacsnsessessassannsenee 103
`
`Annex R (normative) Adverse eventclassification during clinical investigation ........ss0ess0 106
`Annex S (informative) Echocardiographic protocol...........::ssssrsssesserserssssssessersnssatenensnssavennsnsasncenen 142
`
`BiloliocgreapaMy saaaeespsstsactansnnrapieaveaaaceseiectnieisaiagaassracsnpssiniaranncbisishowsssavaieatiajdsdpinbtarciersiee|anieradenteadavinamenniner 115
`
`Figures
`
`Figure 1 — Schematic representation of flow waveform and regurgitant volumes for one
`GYGl Oe cciaccaissaisaaguaannapantaenapaniagebraaaeheaugouaes coedss laseunudaeu teeyatta oe sina Soleo deeunasbabuaaernnigeocoteeeadl
`
`Figure 2 — Schematic representation of the positive pressure period of an aortic forward
`HOW inte Val siasicscassnecinssascncaccsapvasinijensornindasaeintlassgaiiaievinanntai psasinpaniapedbargieaionisows russiavevssnveuaianevendinmied D
`
`Figure, Bit Example Aaiissnnisintaranistaedsvasiivinccausensasctssanicicesasagsvieiapissabasanias babs lainasadlelipistaannianimuisuiaacecciere BO
`
`Figure B.2|/— Example, Bsgivispestensesdascigetestivestndasaniuteatpvndsihataghd inven setacsatscvadsvccactedccancy4aqeenatenieincar isan 39
`
`Figure! B.3 — Example Gisissanisesnisetesitabineasiseaaiineay.ticcecacapsbigetiovaesacbeiuetbduetasadsaddeancaciecdaibiatacialenentannmceccere 39
`
`Rigure B.4)— Exam ple, Disisisscvciainndinscisiansariasiaasdtactecndeieslefelaiteaat ili kate ietboaaahtiancesedaecdeieetarate 40
`
`Figure B.5 — Example Esssssssssssssssessssasnsosensonsassrcosersernsentansrasnatarssvatacsersetansesarsnsaesessesassssessnserasceseracensasteeee 40
`
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`

`Figure B.6 — Example F sssscssssscassacsersssasssnsenestesorsstansansenantsesssscsssansabesbeatsnsanrasatsarastarasantansansecseansaresoriararier 441
`Figure B.7 — Example G secseresecsnsecceenenessesssenesansarsenavansaneneisrenrenanrsrensiseseasenstenrensesersieestneaeteranssssesesensenseses 41
`Figure B.8 — Exarnple H...ssssscssssssessssersnsorsnsessnsenssssessesarsnsassssnnsarnssnssessrsensenssssssntnssssatsnsassnsatavssssnscesssserense 42
`
`Figure B.9 — Exarmple|....scsssscsssesesesenserensesenscscnsnstsesersesansesansunanesnaasacsaratesasstsnsatensesatserseersersesesesnstenneesens 42
`
`Figure B.10 — Example J -......ccccssssesescenensessnseseeneerserereesersssassenssransaransacacsscassseneesnsnsnsansessnactsnscnenssscossnenes 43
`
`Figure B.11 — Example Kosssssssssrssssserscsesscsnssnsnssnenssassssaessrensessusssnsnsasaesesassesueseressransersesersnseestsnssesssessenssseer 43
`Figure J.1 — Example DSC graphfor single-stage transformation nickel-titanium alloy..........0. 72
`Figure J.2 —- Typical stress-strain curve of superelastic (SE) nitinol indicating various
`reportable Parameters v.rsscseccesseserensesessesessesesessesescssescscesesnseesensrsenersnscsensnesnsnsseeterseserstserstseserseseras OA
`
`Figure J.3 — Force-diametercurve of a superelastic (SE) nitinol support structure
`demonstrating chronic outward force (COF) and radial resistive force (RRF)...:.c0ssseees 76
`
`Figure P.1 — Example schematic of a structural componentfatigue assessment using a
`Stress-or strain-life APPrOACH ......ssscssssessssseeescenessssoeessensesseseeesscenseessorsstentesssserseoestsersarsseneessserss OO
`
`Tables
`
`Table 1 — Heart valve substitute operational environmentforleft side of heart — Adult
`POPUIAtiON saseccnssceosssssscsnsnssancaransusesssvsseinnenisteesersnsnenssnrmasnssosineierdotadsssnissndusanarssidataiaeassanasnerapnasaninre 12
`
`Table 2 — Heart valve substitute operational environment for right side of heart — Adult
`POPU AtION veisasividvergdiascataraaisedsuaadsacnasapienmmiebinadrestsdreindeeiverelsGeasdvesssseniawsiaueisciaiaieiti acenatiaicia AS
`
`Table 3 — Minimum device performance requirements, AOPtiC ......sssscecesseeeresseeeriesneeesrseseeees 18
`
`Table 4—Minimum device performance requirements,Mitral ......cccsssecessseeesseseseeesesescesrseseees 19
`
`Table G.1 — Transcatheter heart valve substitute hazards, associated failure modes and
`OVAIUAtION MEtHOS sa ivissivsiseusroeincdinsdatuiqucduiavaitnciiuarsduwedbcsisigusdbisdduiambuliasiseatibaiakivinisacsidmnsanieemainieO2
`
`Table H.1 — Pediatric definitions sesissiaeisetsasaieidedannnereinvadetigespeetecitceterence cick entn eral ennai D7
`
`Table H.2 — Pulsatile flow test Conditions: left Side@......cccccccceseeeeeeereeseesnneeeserterenteeeseeteeeneeessrteres OO
`
`Table H.3 — Pulsatile flow test conditions: right Side ...........:cscccesseecseneenseessereeensnecssatenensenenseeeees OO
`
`Table H.4 — Steady back pressure and forward flow conditions: left Side ......cccceeeeretseeeeneee OD
`
`Table H.5 — Steady back pressure and forward flow conditions: right Side ..........0:ccseeesesesseeserees OD
`
`Table H.6 — AWTtest conditions: left Side ..........c:cscsceccetseseieeseteeseessssseeeeeesneessceseseuseescreesaneessereees OO
`Table H.7 — AWTtest conditions: right Side ..sezsscsessorsvsvsvsveseerersvssssvsseeeressarersuesnsnetenensensrsnseeeereeenreranases 60
`Table H.8 — FEA/life analysis conditions: left Side@..........cecsssssetssesseessessetessessessseessssscsestaccsseesscesees OF
`
`Table H.9 — FEAllife analysis conditions: right Side .........0scsssessseecsseesreecerenserensenenensenenenseneneseneeeeer OF
`
`Table Q.1—Examplesof evaluations.....:sscssssssccscccssessssersereesensnssnsenansonsensesssetsersesesessansrseeesenssesacesansers 104
`
`Table R.1—Examples of adverse events clinical outcome severity ranking .......:csesseessererencenes 110
`
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`Glossary of equivalent standards
`
`International Standards adopted in the United States may include normative references to other International
`Standards. AAMI maintains a currentlist of each International Standard that has been adopted by AAMI (and ANSI).
`Available on the AAMI website at the address below,this list gives the corresponding U.S. designation and level of
`equivalency to the International Standard.
`
`www.aami.org/standards/glossary.pdf
`
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`© 2013 Association for the Advancementof Medical Instrumentation m ANSI/AAMI/ISO 5840-3:2013
`
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`

`

`Committee representation
`
`Association for the Advancement of Medical Instrumentation
`
`Cardiac Valve Committee
`
`The adoption of ISO 5840-3:2013 as an American National Standard wasinitiated by the AAMI Cardiac Valve
`Committee. The AAMI Cardiac Valve Committee also functions as a U.S. Technical Advisory Group to the relevant
`work in the international Organization for Sterilization (ISO). U.S. representatives from the AAMI Cardiac Valve
`Committee (U.S. Sub-TAG for ISO/TC 150/SC 2/WG 1, Cardiac valves) played an active part in developing the ISO
`standard.
`
`At the time this document was published, the AAMI Cardiac Valve Committee had the following members:
`
`Cochairs:
`
`Members:
`
`Ann M. Graves
`Ajit Yoganathan, PhD
`
`Richard W. Bianco, University of Minnesota
`Jeffrey Borer, MD, Weill Cornell Medical College of Cornell University
`Lawrence Burr, MD, Vancouver, BC, Canada
`Robert Chang, Sadra Medical
`James C. Conti, PhD, Dynatek Labs
`Robert W.M. Frater, MD, Bronxville, NY
`Ann M. Graves St. Jude Medical
`Stephen Hilbert, PhD MD, Children’s Mercy Hospital
`Timothy A. Kelley, Medtronic, Inc.
`Salvador Marquez, Edwards LifeSciences
`David Mester, W.L. Gore & Associates
`Keith Morel, DEKRA
`Stanton P. Nolan, MD, University of Virginia Health Sciences Center
`Jonas Runquist, HLT Inc.
`Hartzell Schaff, MD, Mayo Clinic
`Julie Selstrom, Direct Flow Medical, Inc.
`Sandy F. Stewart, PhD, Center for Devices and Radiological Health, U.S. Food and Drug
`Administration
`Craig Weinberg, PhD, Biomedical Device Consultants & Laboratories
`Julie Zaha, RN Southeastern Regional Medical Center
`Ajit Yoganathan, PhD, Georgia Institute of Technology
`
`Alternates:
`
`Lori Adels, BA PhD, Edwards LifeSciences
`Fernando Aguel, Center for Devices and Radiological Health, U.S. Food and Drug Administration
`Aaron Chalekian, St. Jude Medical Cardiovascular Division, Inc.
`Carol E. Eberhart, Medtronic, Inc.
`Helen Lavin, Sadra Medical
`Elaine, Strope, PhD, Dynatek Labs
`Steven L. Weinberg, PhD, Biomedical Device Consultants & Laboratories
`David Williams, RN MSN, W.L. Gore & Associates
`
`NOTE—Participation by federal agency representatives in the development of this standard does not constitute
`endorsement by the federal governmentor anyof its agencies.
`
`AAMI
`Single user license provided to AAMI standards committee members.
`
`© 2013 Association for the Advancement of Medical Instrumentation m ANSI/AAMI/ISO 5840-3:2013
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`Background of ANSI/AAMI adoption of ISO 5840-3:2013
`
`the International Organization for
`As indicated in the foreword to the main body of this document (page ix),
`Standardization (ISO) is a worldwide federation of national standards bodies. The United States is one of the ISO
`members that took an active roie in the development of this standard, which was developed by ISO Technical
`Subcommittee 150/SC 2, Cardiovascular implants and extracorporeal systems,to fill a need for standardization in the
`field of transcatheter heart valve substitutes.
`
`U.S. participation in this ISO SC is organized through the U.S. Technical Advisory Group for ISO/TC 150/SC 2,
`administered by the Association for the Advancement of Medical Instrumentation (AAMI). The U.S. TAG for ISO/TC
`150/SC 2 supports the guidance provided in this document to select appropriate verification/validation tests and
`methods that are to be derived from risk assessment and define operational conditions and performance
`requirements where adequate scientific and/or clinical evidence exists for their justification.
`
`The U.S. adoption of ANSI/AAMI/SO 5840-3:2013 was approved by the American National Standards Institute
`(ANSI) on 4 December 2012. The AAMI Cardiac Valve Committee (U.S. Sub-TAG for ISO/TC 150/SC 2/WG 1,
`Cardiac valves)initiated the U.S. adoption of ISO 5840-3:2013.
`
`AAMI and ANSI procedures require that standards be reviewed and, if necessary, revised every five years to reflect
`technological advances that may have occurred since publication.
`
`AAMI (and ANSI) have adopted other ISO standards. See the Glossary of Equivalent Standards for a list of ISO
`standards adopted by AAMI which gives the corresponding U.S. designation and the level of equivalency with the
`ISO standard.
`
`As used within the context of this document, “shall” indicates requirements strictly to be followed to conform to the
`standard. “Should” indicates that among several possibilities, one is recommended as particularly suitable, without
`mentioning or excluding others, or that a certain course of action is preferred but not necessarily required, or that (in
`the negative form) a certain possibility or course of action should be avoided but is not prohibited. “May” is used to
`indicate that a course of action is permissible within the limits of the standard. “Can” is used as a statement of
`possibility and capability. Finally, “must” is used only to describe “unavoidable” situations, including those mandated
`by governmentregulation.
`
`The concepts incorporatedin this document should not be consideredinflexible or static. This standard, like any other,
`must be reviewed and updated periodically to assimilate progressive technological developments. To remain relevant,
`it must be modified as technological advances are made and as new data come tolight.
`
`improving this document are invited. Comments and suggested revisions should be sent to
`Suggestions for
`Standards Department, AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633.
`
`NOTE—Beginning with the ISO foreword on pageix, this American National Standard is identical to ISO 5840-3:2013.
`
`AAMI
`Single userlicense provided to AAMI standards committee members.
`
`viii
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`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.
`
`International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
`
`International
`to prepare International Standards. Draft
`The main task of technical committees is
`Standards adopted by the technical committees are circulated to the member bodies for voting.
`Publication as an International Standard requires approval by at least 75 % of the member bodies casting
`a vote.
`
`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 patentrights.
`
`ISO 5840-3 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee
`SC 2, Cardiovascular implants and extracorporeal systems.
`
`ISO 5840 consists of the following parts, under the generaltitle Cardiovascular implants — Cardiac valve
`prostheses:
`
`— Part 3: Heart valve substitutes implanted by minimally invasive techniques
`
`AAMI
`Singleuserlicense provided to AAMI standards committee members.
`
`© 2013 Association for the Advancementof Medical Instrumentation a ANSI/AAMI/ISO 5840-3:2013
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`Introduction
`
`No heart valve substitute is ideal. Therefore, a group of engineers, scientists and clinicians well aware of
`the problems associated with heart valve substitutes and their development has prepared this part of
`ISO 5840.
`In several areas, the provisions of this part of ISO 5840 have been deliberately left partially
`defined so as not to inhibit development and innovation. This part of ISO 5840 specifies types of tests,
`test methods and requirements for test apparatus. It requires documentation of test methods and results.
`This part of ISO 5840 deals with those areas that will ensure adequate mitigation of device-associated
`risks for patients and other users of the device,facilitate quality assurance, aid the cardiac surgeon and
`cardiologist
`in choosing a heart valve substitute, and ensure that the device will be presented in a
`convenient form. This part of ISO 5840 emphasizes the need to specify types ofin vitro testing, preclinical
`in vivo and clinical evaluations as well as to report all in vitro, preclinical in vivo and clinical evaluations.It
`describes the labels and packaging of the device. Such a processinvolving in vitro, preclinical in vivo and
`clinical evaluations is intended to clarify the required procedures prior to market release and to enable
`promptidentification and managementof any subsequent problems.
`
`With regard to in vitro testing and reporting, apart from basic material testing for mechanical, physical,
`chemical and biocompati