用于COVID-19醫(yī)療環(huán)境的3D打印和3D打印產(chǎn)品的合格評定程序

Conformityassessmentproceduresfor3Dprintingand3Dprintedproducts

tobeusedinamedicalcontextforCOVID-19

Q1:IsthereanyapplicableEUlegalframeworksinthecaseof3Dprinting?

3DPrinting(3DP)–alsoknownasAdditiveManufacturing(AM)-isamanufacturingprocessthat

uses3DPrinters–alsoknownasAdditiveManufacturingmachinery-tofabricateothermarket

products.

3DPrinters–alsoknownasAdditiveManufacturingmachineryaremeansofproductionthatcanbeusedtomanufacturevariousproductsfordifferentapplications.

3Dprintersareamongtheso-called‘harmonisedproducts’forwhichthereisspecificEUproduct

harmonisationlegislationinplace.Inparticular,theyfallunderthedefinitionofmachineryunderthe

Machinery

Directive

2006/42/EC

.

Thus,manufacturersmustensurethecomplianceof3DPrinters

withtheapplicableessentialhealthandsafetyrequirementsoftheMachineryDirective,composea

technicalfileandaffixtheCE-markingbeforeplacingthemontheEUinternalmarket.

BesidestheMachineryDirective,otherEUpiecesoflegislationmayapplyto3Dprinters;i.e.the

Electromagnetic

Compatibility

Directive

2014/30/EC

,

andEUlegislationonchemicals,

WEEE

2012/19/EU

,

RoHS

II

2011/65/EU

Directive

and

Directive

(EU)

2017/2102

,

and

REACH

1907/2006/EU

.

ProductsdesignedandmanufacturedinaccordancewiththeMachineryDirective2006/42/ECcan

circulatefreelythroughouttheinternalmarketandMemberStatesmaynotintroduceadditional

and/ordivergingrequirementsregardingthemanufacturingandplacementonthemarketofsuch

products.

3Dprintedproductsinthemselvesmaybeusedtoproducemedicaldeviceswhichfallwithinthe

scopeofspecificEUproductlegislation,suchastheMedicalDevicesDirective93/42/EEC1.Therefore,

manufacturersofsuchmedicaldevicesmustensurethat3Dprintedproductsmeettherequirements

oftheapplicableEUlegislation2,carryoutthenecessaryconformityassessmentprocedures,

composeatechnicalfile,drafttheEUdeclarationofconformityandaffixtheCEmarking,before

placingthemontheEUmarket3.(cf.questionsbelow)

1Pleasenotethatwhenthenew

Regulation

(EU)

2017/745

entersintofullapplication,itwillreplacethe

Directive93/42/EEC.However,accordingtothetransitionalprovisionsofArt.120ofthatRegulation,devices

compliantwithDirectivecancontinuetobeplacedonthemarketundercertainconditionsandinaccordance

withcertaintimelines.

2Currently,medicaldevicesareruledbyDirective93/42/EEC,concerningmedicaldevices;Directive98/79/EC

oninvitrodiagnosticmedicaldevicesandDirective90/385/EECrelatingtoactiveimplantablemedicaldevices.

3FormoreinformationontheproductcoverageofEUproductlegislationandtheCEmarking,see:

https://ec.europa.eu/growth/single-market/ce-marking/

1

Q2:ArethereanymandatoryEUstandardsfor3Dprinters?

Concerningthe3Dprinter,themanufacturerofmachineryorhisauthorisedrepresentativemust

ensurethatariskassessmentiscarriedoutinordertodeterminethehealthandsafetyrequirements

whichapplytothemachinery.Themachinerymustthenbedesignedandconstructedtakinginto

accounttheresultsofsuchriskassessment.

TheMachineryDirective2006/42/EClaysdownessentialrequirementsonhealth,safetyand

performanceoftheproductstheycover.However,thisEUlegalframeworkistechnologicallyneutral

anddoesnotprescribeanyspecificmandatorytechnicalsolutionsforthedesignoftheproducts.

Therefore,anumberoftechnicalsolutionsmaybeusedbymanufacturerstomeettheseessential

requirements.

TheMachineryDirectiveoffersthepossibilityformanufacturerstorelyonspecifictechnical

solutions,whicharedetailedinharmonisedEuropeanstandardsorpartsthereofthereferencesof

whichhavebeenpublishedintheOfficialJournaloftheEuropeanUnion(OJEU).Shoulda

manufacturerchoosetoadoptsuchatechnicalsolution,theproductispresumedtobeinconformity

withtheapplicableessentialhealth,safetyandperformancerequirementsthattheharmonised

standardaimtocover.Otherwise,ifthemanufacturerchoosetoadoptanyothertechnicalsolution,

(s)hemustgiveadetailedexplanationonthecomplianceofsuchtechnicalsolutionwiththeEU

legislationrequirementsinthetechnicalfile.

ThefollowingaresomeofthemostrelevantharmonisedstandardscitedintheOJEUundertheMachineryDirective4forlaser-based3Dprinters(metal):

ENISO12100(Safetyofmachinery–Generalprinciplesfordesign–Riskassessmentandrisk

reduction)

EN60204-1(Safetyofmachinery–Electricalequipmentofmachines)

EN13849-1(Safetyofmachinery–Safety-relatedpartsofcontrolsystems)

EN13850(Safetyofmachinery–Emergencystopfunction–Principlesfordesign)

ENISO11553-1(Laserprocessingmachines)

EN1127-1(Explosiveatmospheres–Explosionpreventionandprotection)

ENISO19353(Safetyofmachinery–Firepreventionandfireprotection)

Forplasticprinters,fireandexplosionstandardsarerelevanttoo.

Inaddition,itisusefultoconsidersomenon-harmonisedstandardsforlaserproducts/safety;

EN60825-1(Safetyoflaserproducts–Part1:Equipmentclassificationandrequirements)

EN60825-4(Safetyoflaserproducts–Part4:Laserguards)

Q3:IsthereanyapplicableEUlegalframeworkfor3Dprintedproductsusedinamedicalcontext?

Dependingontheintendedpurposeofthe3Dprintedproduct,theymayqualifyasmedicaldevices,

oraccessoriesaccordingtothedefinitionssetoutinthemedicaldeviceslegislation.Suchproducts

4Harmonisedstandardsformachiner

y:

https://ec.europa.eu/growth/single-market/european-

standards/harmonised-standards/machinery

2

mustfulfilallapplicablerequirementsof

Directive

93/42/EEC

5

.Inparticular,accessoriesofmedical

devices(whicharenotinthemselvesmedicaldevices),butareintendedbythemanufacturertobe

usedspecificallytoenabletheuseofamedicaldevice,mayqualifyasdevicesandshallmeetthe

requirementsofthemedicaldeviceslegislation.Thisisnotnecessarilythecaseforpartsand

componentsofmedicaldevices,whichdon’thaveregulatorystatusundertheMedicalDevices

Directive93/42/EEC,howeverarenonethelessexpectedtosatisfythesafetyrequirementsofa

medicaldevice,beingpartthereof.

Forexample,3Dprintedplasticvalvesusedinrespiratoryventilatorsmayqualifyaseither

accessoriesofmedicaldevicesortheirpartsandcomponents.

WheretheconformityassessmentprocedureforthemedicaldeviceisbasedontheManufacturers’QualityManagementSystem,thefollowingharmonizedstandardmaybeused:

ENISO13485:2016Medicaldevices-Qualitymanagementsystems-Requirementsfor

regulatorypurposes(ISO13485:2016)ENISO13485:2016/AC:2018

Accordingtosuchstandard,themanufacturershouldvalidatetheproductionprocessassetoutin

section7.5.6ENISO13485:2016.Amongotherrequirements,thevalidationprocedureshouldalso

includetheequipmentqualification.

Harmonisedstandardsonadditivelymanufacturedpartstobeusedinthemedicaldevicessector.

Therearenoharmonisedstandardsthatspecificallyapplytoadditivelymanufacturedparts

tobeusedinthemedicaldevicessector.However,otherstandardsmaybeused.6

Existingsafetystandardsrelatedtothemanufacturinganduseofthespecific

part/componentinthemedicaldevicessectorareapplicableregardlessofthetypeof

machine/processusedfortheirproduction.

Itisimportanttochoosethecorrectmaterialstodeveloptheneededpartsorcomponents

(hecaseofventilatorvalves,compatibilitytestingbetweenthematerialandthe

enrichedoxygenfluidtobeadministered,shouldbeperformed)

Itisimportanttoapplyappropriatepost-processes(e.g.cleaning,sterilisation,biological

evaluation)tothemanufacturedparttoensuretheabsenceofloosepowderparticlesand

anyotherpotentiallyharmingelements.

OtherspecificrequirementslaiddownintheEUlegislationonmedicaldevicesareaddressed

bystandards,suchasstandardsontheinformationtobesuppliedbythemanufacturer,on

medicalelectricalequipment,etc.

Otherthanharmonisedstandards,designspecificationsforspecificdevicesanddeviceparts,

componentsoraccessoriescanbeacquiredeitherthroughanagreementwithanexistingmedical

devicemanufacturerorthoughcontactinganationalcompetentauthority.7

5Directive93/42/EEC.Seealsofootnote1,regardingthenewRegulation(EU)2017/745.

6SeeISOISO/ASTM52901:2017[ASTMF42]

/standard/67288.html

7Contactinformationcanbefoundonthemedicaldevicessectorial

website

oftheEuropeanCommission.

3

ListofarecentlypublishedlistofharmonisedstandardsundertheMedicalDevicesDirective

relevantforventilatorparts,componentsandaccessories

ENISO17510-1:2009Sleepapnoeabreathingtherapy-Part1:Sleepapnoeabreathing

therapyequipment(ISO17510-1:2007)

ENISO17510-2:2009Sleepapnoeabreathingtherapy-Part2:Masksandapplication

accessories(ISO17510-2:2007)

EN12342:1998+A1:2009Breathingtubesintendedforusewithanaestheticapparatusand

ventilators

ENISO8835-3:2009Inhalationalanaesthesiasystems-Part3:Transferandreceivingsystems

ofactiveanaestheticgasscavengingsystems(ISO8835-3:2007)ENISO8835-3:2009/A1:201

ENISO5366-1:2009Anaestheticandrespiratoryequipment-Tracheostomytubes-Part1:

Tubesandconnectorsforuseinadults(ISO5366-1:2000)

ENISO7376:2009Anaestheticandrespiratoryequipment-Laryngoscopesfortracheal

intubation(ISO7376:2009)

EN13544-1:2007+A1:2009Respiratorytherapyequipment-Part1:Nebulizingsystemsand

theircomponent

EN13544-2:2002+A1:2009Respiratorytherapyequipment-Part2:Tubingandconnectors

Issuesrelatedtothematerialused

Itisessentialthatthematerialus