通用安全和性能要求檢查表（GSPR Check List）

MDR

AnnexⅠ附錄一

GeneralsafetyandperformancerequirementsChecklist通用安全和性能要求檢查表

Generalsafetyandperformancerequirements通用安全和性能要求

Applicablity適用性StandardsUsed應(yīng)用標(biāo)準(zhǔn)

Evidencecompliance

orreasonforno

applicability符合性證據(jù)或不適用理由

Location-section位置-章節(jié)

CHAPTERI GENERAL

REQUIREMENTS 第1章一般要求1.Devicesshallachievetheperformanceintendedbytheirmanufacturerand

shall

be

designed

and

manufactured

in

such

a

way

that,

during

normalconditionsofuse,theyaresuitablefortheirintendedpurpose.Theyshallbesafeandeffectiveandshallnotcompromisetheclinicalconditionorthesafetyofpatients,orthesafetyandhealthofusersor,whereapplicable,otherpersons,providedthatanyriskswhich

may

beassociatedwiththeiruseconstituteacceptableriskswhenweighedagainstthebenefitstothepatientandarecompatiblewithahigh.1.器械應(yīng)具備制造商預(yù)期的性能，并確保其設(shè)計(jì)和結(jié)構(gòu)在正常使用條件下適用于其預(yù)期用途。器械應(yīng)安全有效，且不得對(duì)患者的臨床癥狀或安全或者使用者或其他人員（如適用）的安全和健康造成損害，在最大限度保護(hù)健康和安全的同時(shí)，器械使用的可接受風(fēng)險(xiǎn)與其對(duì)患者的受益相比，應(yīng)在可接受范圍內(nèi)，并應(yīng)考慮到符合現(xiàn)有認(rèn)知水平。

2.The

requirement

in

this

Annex

to

reduce

risks

as

far

as

possible

meansthe

reduction

of

risks

as

far

as

possible

without

adversely

affecting

thebenefit-riskratio.

2.本附錄中盡可能降低風(fēng)險(xiǎn)的要求，指盡可能降低風(fēng)險(xiǎn)的同時(shí)不會(huì)對(duì)受益-風(fēng)險(xiǎn)比產(chǎn)生不利影響。

3.Manufacturers

shall

establish,

implement,

document

and

maintain

a

riskmanagementsystem.

123.制造商應(yīng)建立、實(shí)施、記錄和維護(hù)風(fēng)險(xiǎn)管理體系。Riskmanagementshallbeunderstoodasacontinuousiterativeprocessthroughout

the

entire

lifecycle

of

a

device,

requiring

regular

systematicupdating.Incarryingoutriskmanagementmanufacturers

shall:

風(fēng)險(xiǎn)管理應(yīng)理解為在器械整個(gè)生命周期中為連續(xù)迭代過(guò)程，需定期進(jìn)行系統(tǒng)更新。進(jìn)行風(fēng)險(xiǎn)管理制造商應(yīng)做到：

establishanddocumentariskmanagementplanforeachdevice;制訂并記錄各器械的風(fēng)險(xiǎn)管理計(jì)劃；

identify

and

analyse

the

known

and

foreseeable

hazards

associated

witheachdevice;

識(shí)別和分析與各器械相關(guān)的已知和可預(yù)見(jiàn)的危害；

estimate

and

evaluate

the

risks

associated

with,

and

occurring

during,theintendeduseandduringreasonablyforeseeable

misuse;

估計(jì)和評(píng)價(jià)在預(yù)期使用時(shí)及在可合理預(yù)見(jiàn)的使用不當(dāng)時(shí)產(chǎn)生的相關(guān)風(fēng)險(xiǎn)；

eliminateorcontroltherisksreferredtoinpoint(inaccordancewiththerequirementsofSection

4;

根據(jù)第

4

節(jié)的要求消除或控制(c)點(diǎn)所述的這些風(fēng)險(xiǎn)；evaluatetheimpactofinformationfromtheproductionphaseand,

inparticular,

from

the

post-market

surveillance

system,

on

hazards

and

the

frequencyofoccurrencethereof,onestimatesoftheirassociatedrisks,aswellasontheoverallrisk,benefit-riskratioandriskacceptability;

and

評(píng)估生產(chǎn)階段，特別是上市后監(jiān)管體系的信息、危害及其發(fā)生頻率、評(píng)估其相關(guān)風(fēng)險(xiǎn)及總體風(fēng)險(xiǎn)、風(fēng)險(xiǎn)利益比和風(fēng)險(xiǎn)可接受性。

basedontheevaluationoftheimpactoftheinformationreferred

toinpoint(e),ifnecessaryamendcontrolmeasuresinlinewith

the

requirementsof

Section

3根據(jù)(e)點(diǎn)所述信息影響的評(píng)估，必要時(shí)根據(jù)第

4

節(jié)的要求修改控制措施。

4.Riskcontrolmeasuresadoptedbymanufacturersforthedesignandmanufactureofthedevicesshallconformtosafetyprinciples,takingaccount

of

the

generally

acknowledged

state

of

the

art.

To

reduce

risks,Manufacturers

shall

manage

risks

so

that

the

residual

risk

associated

witheachhazardaswellastheoverallresidualriskisjudged

acceptable.In

selecting

the

most

appropriate

solutions,

manufacturers

shall,

in

thefollowingorderof

priority:

制造商就器械的設(shè)計(jì)和生產(chǎn)所采取的風(fēng)險(xiǎn)控制措施應(yīng)符合安全原則，并考慮到現(xiàn)有的技術(shù)水平。為降低風(fēng)險(xiǎn)，制造商應(yīng)對(duì)風(fēng)險(xiǎn)進(jìn)行管理，使各危害相關(guān)的剩余風(fēng)險(xiǎn)及總剩余風(fēng)險(xiǎn)控制在可接受范圍內(nèi)。在選擇最合適的解決方案時(shí)，制造商應(yīng)依據(jù)下述優(yōu)先級(jí)原則：

eliminate

or

reduce

risks

as

far

as

possible

through

safe

designandmanufacture;

通過(guò)安全的設(shè)計(jì)和生產(chǎn)盡可能消除或降低風(fēng)險(xiǎn)；

where

appropriate,

take

adequate

protection

measures,

includingalarms

if

necessary,

in

relation

to

risks

that

cannot

be

eliminated;

and如適合，采取適當(dāng)保護(hù)措施，關(guān)于無(wú)法消除的風(fēng)險(xiǎn)，包含必要時(shí)的報(bào)警；且

provideinformationforsafety

(warnings/precautions/contra

-indications)and,whereappropriate,trainingto

users.

提供安全信息（警戒/預(yù)防措施/禁忌），并在適當(dāng)情況下向使用者提供培訓(xùn)。Manufacturersshallinformusersofanyresidual

risks.

制造商應(yīng)將剩余風(fēng)險(xiǎn)告知使用者。

5.In

eliminating

or

reducing

risks

related

to

use

error,

the

manufacturershall:

5.在消除或減少使用不當(dāng)相關(guān)風(fēng)險(xiǎn)時(shí)，制造商應(yīng)：

(a)

reduce

as

far

as

possible

the

risks

related

to

the

ergonomic

features

4of

the

device

and

the

environment

in

which

the

device

is

intended

to

beused(designforpatientsafety),

and

盡量降低因器械人體工程學(xué)特點(diǎn)及其預(yù)期使用環(huán)境所造成的風(fēng)險(xiǎn)（針對(duì)患者安全而設(shè)計(jì)），以及

(b)giveconsiderationtothetechnicalknowledge,experience,education,traininganduseenvironment,whereapplicable,and

themedicalandphysicalconditionsofintendedusers(designforlay,professional,disabledorother

users).

針對(duì)技術(shù)知識(shí)、經(jīng)驗(yàn)、教育、培訓(xùn)和使用環(huán)境，以及預(yù)期使用者醫(yī)療及身體條件（如適用）的注意事項(xiàng)（針對(duì)非專(zhuān)業(yè)、專(zhuān)業(yè)、殘疾或其他使用者而設(shè)計(jì)）。

6.The

characteristics

and

performance

of

a

device

shall

not

be

adverselyaffected

to

such

a

degree

that

the

health

or

safety

of

the

patient

or

theuser

and,

where

applicable,

of

other

persons

are

compromised

during

the

lifetime

of

the

device,

as

indicated

by

the

manufacturer,

when

the

deviceis

subjected

to

the

stresses

which

can

occur

during

normal

conditions

ofuse

and

has

been

properly

maintained

in

accordance

with

the

manufacturer'sinstructions.

6.如器械在正常使用環(huán)境中使用并根據(jù)制造商的指示進(jìn)行適當(dāng)維護(hù)保養(yǎng)，在制造商聲稱(chēng)的使用期限內(nèi)器械的特性和性能不得對(duì)患者、使用者或其他人員（如適用）的健康或安全造成損害。

7.Devices

shall

be

designed,

manufactured

and

packaged

in

such

a

way

thattheir

characteristics

and

performance

during

their

intended

use

are

notadverselyaffectedduringtransportandstorage,forexample,throughfluctuationsoftemperatureandhumidity,takingaccountoftheinstructionsandinformationprovidedbythemanufacturer.

7.器械的設(shè)計(jì)、生產(chǎn)和包裝應(yīng)確保在根據(jù)制造商提供的說(shuō)明和信息進(jìn)行運(yùn)輸和儲(chǔ)存期間（如溫度和濕度的波動(dòng)），不會(huì)對(duì)器械在預(yù)期使用期間的特性和性能造成

5不利影響。

8.Allknownandforeseeablerisks,andanyundesirableside-effects,shall

be

minimised

and

be

acceptable

when

weighed

against

the

evaluatedbenefits

to

the

patient

and/or

user

arising

from

the

achieved

performanceofthedeviceduringnormalconditionsof

use.

8.與正常使用條件下器械預(yù)期性能對(duì)患者和/或使用者產(chǎn)生的潛在益處相比，所有已知和可預(yù)見(jiàn)的風(fēng)險(xiǎn)及任何不良影響應(yīng)最小化并控制在可接受范圍內(nèi)。

9.ForthedevicesreferredtoinAnnexXVI,thegeneralsafetyrequirements

set

out

in

Sections

1

and

8

shall

be

understood

to

mean

thatthe

device,

when

used

under

the

conditions

and

for

the

purposes

intended,doesnotpresentariskatallorpresentsariskthatisnomorethanthemaximumacceptableriskrelatedtotheproduct'susewhichisconsistent

with

a

high

level

of

protection

for

the

safety

and

health

of

persons.

9.對(duì)于在附錄十六中所列出的，制造商未聲稱(chēng)用于醫(yī)療目的之器械，應(yīng)充分了解在第

1

節(jié)和第

8

節(jié)規(guī)定的通用安全要求，即在預(yù)期條件下出于預(yù)期目的而使用器械時(shí)，器械不得出現(xiàn)任何風(fēng)險(xiǎn)，或出現(xiàn)不超過(guò)與產(chǎn)品使用相關(guān)的最大可接受風(fēng)險(xiǎn)，這符合高水平保障人員安全和健康原則一致。

CHAPTERII REQUIREMENTSREGARDINGDESIGNAND

MANUFACTURE

第2章

設(shè)計(jì)和生產(chǎn)相關(guān)要求10.Chemical,physicalandbiological

properties10.化學(xué)、物理和生物學(xué)特性

10.1.Devicesshallbedesignedandmanufacturedinsuchawayastoensurethat

the

characteristics

and

performance

requirements

referred

to

in

Chapter

I

arefulfilled.Particularattentionshallbepaid

to:

器械的設(shè)計(jì)和生產(chǎn)應(yīng)當(dāng)能確保符合第

I

章中所述的特性和性能要求。特別注意：

(a)thechoiceofmaterialsandsubstancesused,particularlyasregards

toxicity

6and,whererelevant,flammability;

使用材料和物質(zhì)的選擇，特別是毒性和易燃性（如適用）

thecompatibilitybetweenthematerialsandsubstancesusedandbiologicaltissues,cellsandbodyfluids,takingaccountoftheintendedpurposeofthedevice

and,

where

relevant,absorption,

distribution,metabolism

and

excretion;所使用材料和物質(zhì)與生物組織，細(xì)胞及體液間的相容性，及考慮到器械使用目的及相關(guān)的吸收、分布、新陳代謝和排泄；

thecompatibilitybetweenthedifferentpartsofadevicewhichconsistsofmorethanoneimplantable

part;

器械不同部件之間的兼容性，該器械由多個(gè)可植入部件組成；

the

impact

of

processes

onmaterialproperties;過(guò)程對(duì)材料性能的影響；(e)whereappropriate,theresultsofbiophysicalormodellingresearchthevalidityofwhichhasbeendemonstrated

beforehand;若適用，生物物理學(xué)或建模研究結(jié)果有效性已事先獲得證實(shí)；

themechanicalpropertiesofthematerialsused,reflecting,whereappropriate,matterssuchasstrength,ductility,fractureresistance,wearresistanceandfatigueresistance;所使用材料的機(jī)械性能，在適當(dāng)情況下反映諸如強(qiáng)度、延展性、抗斷裂性、耐磨性和耐疲勞強(qiáng)度等問(wèn)題；

surfaceproperties;and

表面活性；

theconfirmationthatthedevicemeetsanydefinedchemicaland/orphysicalspecifications.確認(rèn)該器械滿(mǎn)足任何確定的化學(xué)和/或物理要求。

10.2.Devicesshallbedesigned,manufacturedandpackagedinsuchawayastominimisetheriskposedbycontaminantsandresiduestopatients,takingaccountoftheintendedpurposeofthedevice,andtothepersonsinvolvedinthetransport,storageanduseofthedevices.Particularattentionshallbepaid

totissuesexposedtothosecontaminantsandresiduesandtotheduration

and

7frequencyof

exposure.器械的設(shè)計(jì)、生產(chǎn)和包裝應(yīng)盡可能降低污染物和殘留物對(duì)患者造成的風(fēng)險(xiǎn)，同時(shí)考慮到器械預(yù)期用途以及參與器械運(yùn)輸、儲(chǔ)存和使用的人員。

應(yīng)當(dāng)特別注意暴露于這些污染物和殘留物的組織以及暴露時(shí)間與頻率。

10.3.Devicesshallbedesignedandmanufacturedinsuchawaythattheycanbeusedsafelywiththematerialsandsubstances,includinggases,withwhich

theyenterintocontactduringtheirintendeduse;ifthedevicesareintendedtoadministermedicinalproductstheyshallbedesignedandmanufacturedinsuchawayastobecompatiblewiththemedicinalproductsconcernedinaccordancewiththeprovisionsandrestrictionsgoverningthosemedicinalproductsandthattheperformanceofboththemedicinalproductsandofthedevicesismaintainedinaccordancewiththeirrespectiveindicationsandintended

use.器械的設(shè)計(jì)和生產(chǎn)應(yīng)以能使其可安全地與材料和物質(zhì)（包括氣體）一起使用，且在預(yù)期使用時(shí)，這些材料和物質(zhì)會(huì)與器械接觸；若器械預(yù)期用于管理醫(yī)療產(chǎn)品，根據(jù)管理這些醫(yī)療產(chǎn)品的條款和限制，則其設(shè)計(jì)和生產(chǎn)應(yīng)使其能夠與相關(guān)的醫(yī)療產(chǎn)品兼容，并應(yīng)可根據(jù)其相應(yīng)的指示和預(yù)期用途維護(hù)醫(yī)療產(chǎn)品和器械的性能。

10.4.

Substances 物質(zhì)

10.4.1.Designand

manufacture

of

devices

器械的設(shè)計(jì)和生產(chǎn)

substancesorparticles,includingweardebris,degradationproductsandprocessingresidues,thatmaybereleasedfromthe

device.器械的設(shè)計(jì)和生產(chǎn)應(yīng)盡可能降低由物質(zhì)或微粒（包括磨屑、降解產(chǎn)物和加工殘留物）造成的風(fēng)險(xiǎn)，而此類(lèi)物質(zhì)或微?？赡苡善餍诞a(chǎn)生。

Devices,orthosepartsthereoforthosematerialsusedtherein

that:器械或其部件或其使用的材料：

areinvasiveandcomeintodirectcontactwiththehuman

body,(re)administermedicines,bodyliquidsorothersubstances,includinggases,to/fromthebody,

or

8—transportorstoresuchmedicines,bodyfluidsorsubstances,includinggases,tobe(re)administeredtothebody,shallonlycontainthefollowingsubstancesinaconcentrationthatisabove0,1%weightbyweight(w/w)wherejustifiedpursuanttoSection

10.4.2:具有侵入性，并與人體直接接觸，或

（重新）為人體輸送藥物、體液或其他物質(zhì)（包括氣體），或

運(yùn)輸或儲(chǔ)存待（重新）為人體輸送藥物、體液或物質(zhì)（包括氣體），在根據(jù)第節(jié)進(jìn)行調(diào)整時(shí)，應(yīng)僅包含濃度高于

0.1%重量比的以下物質(zhì)：

substanceswhicharecarcinogenic,mutagenicortoxictoreproduction(‘CMR’),ofcategory1Aor1B,inaccordancewithPart3ofAnnexVItoRegulation(EC)No1272/2008oftheEuropeanParliamentandofthe

Council(1),or1A

或

1B

類(lèi)有致癌、致突變或生育毒性('CMR')的物質(zhì)，依據(jù)歐洲議會(huì)和理事會(huì)第

1272/2008

號(hào)法規(guī)附錄

VI

第

3

部分判斷，或substanceshavingendocrine-disruptingpropertiesforwhichthereisscientificevidenceofprobableseriouseffectstohumanhealthandwhichareidentifiedeitherinaccordancewiththeproceduresetoutinArticle59ofRegulation(EC)No1907/2006oftheEuropeanParliamentandoftheCouncil(2)or,onceadelegatedacthasbeenadoptedbytheCommissionpursuanttothefirstsubparagraphofArticle5(3)ofRegulation(EU)No528/2012ofthe

EuropeanParliamentandtheCouncil(3),

in有科學(xué)證據(jù)證明可能對(duì)人類(lèi)健康造成嚴(yán)重影響的具有內(nèi)分泌干擾性質(zhì)的物質(zhì)，根據(jù)歐洲議會(huì)和理事會(huì)第

1907/2006

號(hào)法規(guī)（2）第

59

條規(guī)定程序識(shí)別，或者委員會(huì)根據(jù)歐洲議會(huì)和理事會(huì)第

528/2012

號(hào)法規(guī)（3）第

5（3）條第一段通過(guò)授權(quán)法案后，根據(jù)本法規(guī)規(guī)定之與人類(lèi)健康相關(guān)準(zhǔn)則識(shí)別。

10.4.2.JustificationregardingthepresenceofCMRand/orendocrine-disruptingsubstances

9Thejustificationforthepresenceofsuchsubstancesshallbebased

upon:關(guān)于存在

CMR

和/或內(nèi)分泌干擾物的理由，存在此類(lèi)物質(zhì)的理由應(yīng)基于：

ananalysisandestimationofpotentialpatientoruserexposuretothesubstance;ananalysisofpossiblealternativesubstances,materialsordesigns,including,whereavailable,informationaboutindependent

research,peer-reviewedstudies,scientificopinionsfromrelevantscientificcommitteesandananalysisoftheavailabilityofsuch

alternatives;argumentationastowhypossiblesubstanceand/ormaterialsubstitutes,ifavailable,ordesignchanges,iffeasible,areinappropriateinrelationtomaintainingthefunctionality,performanceandthebenefit-riskratiosoftheproduct;includingtakingintoaccountiftheintendeduseofsuchdevicesincludestreatmentofchildrenortreatmentofpregnantorbreastfeedingwomenortreatmentofotherpatientgroupsconsideredparticularlyvulnerabletosuchsubstancesand/ormaterials;

andwhereapplicableandavailable,thelatestrelevantscientificcommitteeguidelinesinaccordancewithSections10.4.3.and

10.4.4.對(duì)潛在患者或使用者暴露于該物質(zhì)下情況進(jìn)行分析和判斷；

對(duì)可能的替代物質(zhì)、材料或設(shè)計(jì)進(jìn)行的分析，（在可用時(shí)）包括有關(guān)獨(dú)立研究、同等評(píng)審研究、相關(guān)科學(xué)委員會(huì)的科學(xué)意見(jiàn)等信息，以及對(duì)這些替代品可用性的分析；

論證可能的物質(zhì)和/或材料替代品（如有）或設(shè)計(jì)變更（如可行）不適用于維護(hù)產(chǎn)品功能、性能和利益-風(fēng)險(xiǎn)比的原因；包括要考慮這些器械的預(yù)期用途是否包括兒童治療，或孕婦或哺乳婦女治療，或?qū)ζ渌貏e容易受到此類(lèi)物質(zhì)和/或材料影響的患者群體的治療；如適用和可用時(shí)，基于根據(jù)第

10.4.3

節(jié)和

10.4.4.節(jié)制定的最新相關(guān)的科學(xué)委員會(huì)指南。

1010.4.3.Guidelineson

phthalates

10.4.3

鄰苯二甲酸酯使用指南

ForthepurposesofSection10.4.,theCommissionshall,assoonaspossibleandby26May2018,providetherelevantscientificcommitteewithamandatetoprepareguidelinesthatshallbereadybefore26May2020.Themandateforthecommitteeshallencompassatleastabenefit-riskassessmentofthepresenceofphthalateswhichbelongtoeitherofthegroupsofsubstancesreferredtoinpoints(a)and(b)ofSection10.4.1.Thebenefit-riskassessmentshalltakeintoaccounttheintendedpurposeandcontextoftheuseofthedevice,aswellas

anyavailablealternativesubstancesandalternativematerials,designsormedicaltreatments.Whendeemed

appropriate為達(dá)到本附錄第

10.4

條

的目的，委員會(huì)應(yīng)盡快并于

2018

年

5

月

26

日向相關(guān)科學(xué)委員會(huì)提供任務(wù)以制定指南，且本指南應(yīng)在

2020

年

5

月

26

日前編制好。委員會(huì)的任務(wù)至少應(yīng)包含對(duì)鄰苯二甲酸酯存在的利益風(fēng)險(xiǎn)評(píng)價(jià)，其中鄰苯二甲酸酯屬于第

10.4.1

節(jié)要點(diǎn)（a）和（b）中所所述物質(zhì)組中的任何一組。利益風(fēng)險(xiǎn)評(píng)價(jià)應(yīng)考慮器械、可用替代物質(zhì)和替代材料、設(shè)計(jì)和/或藥物治療使用的預(yù)期目的和環(huán)境。雖然根據(jù)最新科學(xué)證據(jù)認(rèn)為是適當(dāng)?shù)?，但?yīng)至少每五年更新一次本指南。

Regulation(EC)No1272/2008oftheEuropeanParliamentandoftheCouncilof16December2008onclassification,labellingandpackagingofsubstancesandmixtures,amendingandrepealingDirectives67/548/EECand1999/45/EC,andamendingRegulation(EC)No1907/2006(OJL353,31.12.2008,p.

1).Regulation(EC)No1907/2006oftheEuropeanParliamentandoftheCouncilof18December2006concerningtheRegistration,Evaluation,AuthorisationandRestrictionofChemicals(REACH)(OJL396,30.12.2006,p.

1).Regulation(EU)No528/2012oftheEuropeanParliamentand

the歐洲議會(huì)和理事會(huì)于

2008

年

12

月

16

日簽發(fā)的關(guān)于物質(zhì)和混合物分類(lèi)、標(biāo)簽和包裝的第

1272/2008

號(hào)法規(guī)，修訂和廢除第

67/548/EEC

號(hào)指令和第

1999/45/EC

號(hào)指令，并修訂了第

1907/2006

號(hào)法規(guī)（OJL

353,

31.12.2008,p.

1）。

歐洲議會(huì)和理事會(huì)于

2006

年

12

月

18

日簽發(fā)的關(guān)于化學(xué)品注冊(cè)、評(píng)價(jià)、授權(quán)和限制（REACH）的第

1907/2006

號(hào)法規(guī)（OJL396,30.12.2006,

p.

1）。歐洲議會(huì)和理事會(huì)于

2012

年

5

月

22

日簽發(fā)的關(guān)于在市場(chǎng)上提供和使用殺生物產(chǎn)品的第

528/2012

號(hào)法規(guī)（OJ

L

167，27.06.2012,p.

1）。

1110.4.4GuidelinesonotherCMRandendocrine-disrupting

substances其他CMR和內(nèi)分泌干擾物質(zhì)的指南Subsequently,theCommissionshallmandatetherelevantscientificcommitteetoprepareguidelinesasreferredtoinSection10.4.3.alsoforothersubstancesreferredtoinpoints(a)and(b)ofSection10.4.1.,where

appropriate.隨后，委員會(huì)應(yīng)授權(quán)相關(guān)科學(xué)委員會(huì)按照第

107.4.3

中所述的要求，也為第10.4.1

節(jié)要點(diǎn)（a）和（b）中所所述的其他物質(zhì)制定指南。

10.4.5

Labelling貼標(biāo)Wheredevices,partsthereoformaterialsusedthereinasreferredtoin

Section10.4.1.containsubstancesreferredtoinpoints(a)or(b)ofSection10.4.1.inaconcentrationabove0,1%weightbyweight(w/w),thepresenceofthosesubstancesshallbelabelledonthedeviceitselfand/oronthepackagingforeachunitor,whereappropriate,onthesalespackaging,withthelistofsuchsubstances.Iftheintendeduseofsuchdevicesincludestreatmentofchildrenortreatmentofpregnantorbreastfeedingwomenortreatmentofotherpatientgroupsconsideredparticularlyvulnerabletosuchsubstancesand/ormaterials,informationonresidualrisksforthosepatient

groups按照第10.4.1

節(jié)所述的要求，若此中所使用的器械、其部件或材料，包含第10.4.1

節(jié)中所述的濃度高于

0.1%重量比的物質(zhì)，則應(yīng)在器械本身和/或各單元的包裝上或，（適當(dāng)時(shí)）在銷(xiāo)售包裝上把此類(lèi)物質(zhì)清單標(biāo)識(shí)清楚。若此類(lèi)器械的預(yù)期用途，包括兒童治療，或孕婦或哺乳婦女治療，或?qū)σ暈樘貏e易受到此類(lèi)物質(zhì)和/或材料影響的其他患者群體的治療，則關(guān)于這些患者群體的剩余風(fēng)險(xiǎn)、（如適用）預(yù)防措施信息，均應(yīng)在使用說(shuō)明中給出。

10.5.Devicesshallbedesignedandmanufacturedinsuchawayastoreduceasfaraspossibletherisksposedbytheunintentionalingressofsubstancesintothedevicetakingintoaccountthedeviceandthenatureoftheenvironmentin

whichitisintendedtobe

used.

12必須合理設(shè)計(jì)及生產(chǎn)器械，以盡量降低因物質(zhì)意外進(jìn)入器械而造成的風(fēng)險(xiǎn)，并且應(yīng)考慮到器械及其預(yù)期使用環(huán)境的性質(zhì)。10.6.Devicesshallbedesignedandmanufacturedinsuchawayastoreduceasfaraspossibletheriskslinkedtothesizeandthepropertiesofparticleswhichareor

can

be

released

into

the

patient's

or

user's

body,

unless

they

come

into

contactwithintactskinonly.Specialattentionshallbegivento

nanomaterials.器械的設(shè)計(jì)和生產(chǎn)應(yīng)盡可能減少與微粒尺寸和性能相關(guān)的風(fēng)險(xiǎn)，除非這些微粒接觸到的是完好的皮膚，否則這些微粒會(huì)位于或可釋放到患者或使用者體內(nèi)。應(yīng)特別注意納米材料。

11.Infectionandmicrobial

contamination感染及微生物污染11.1.Devicesandtheirmanufacturingprocessesshallbedesignedinsuchawayastoeliminateortoreduceasfaraspossibletheriskofinfectiontopatients,usersand,whereapplicable,otherpersons.Thedesign

shall:reduceasfaraspossibleandappropriatetherisksfromunintendedcutsandpricks,suchasneedlestick

injuries,alloweasyandsafe

handling,reduceasfaraspossibleanymicrobialleakagefromthedeviceand/ormicrobialexposureduringuse,

andpreventmicrobialcontaminationofthedeviceoritscontentsuchasspecimensor

fluids.器械和生產(chǎn)過(guò)程的設(shè)計(jì)應(yīng)盡可能消除或減少感染患者、使用者和（適用時(shí)）其他人的風(fēng)險(xiǎn)。設(shè)計(jì)應(yīng)：

盡可能減少并消除意外由于切割和刺破造成的風(fēng)險(xiǎn)，例如針刺損傷；

使用便捷安全；

盡可能降低器械的微生物泄漏和/或使用過(guò)程中的微生物暴露；

防止器械或其所包含之物（例如樣本或液體）受到微生物的污染。

1311.2.Wherenecessarydevicesshallbedesignedtofacilitatetheirsafecleaning,disinfection,and/or

re-sterilisation.必要時(shí)，應(yīng)將器械設(shè)計(jì)成便于進(jìn)行安全清潔、消毒和/或再滅菌。

11.3.Deviceslabelledashavingaspecificmicrobialstateshallbedesigned,manufactured

and

packaged

to

ensure

that

they

remain

in

that

state

when

placedonthemarketandremainsounderthetransportandstorage

conditionsspecifiedbythemanufacturer.應(yīng)對(duì)標(biāo)記為具有特殊微生物種群的器械進(jìn)行設(shè)計(jì)、生產(chǎn)和包裝，以確保在投放到市場(chǎng)時(shí)，及在制造商規(guī)定的運(yùn)輸和儲(chǔ)存條件下，器械依舊保持原樣。

11.4.Devicesdeliveredinasterilestateshallbedesigned,manufacturedandpackagedinaccordancewithappropriateprocedures,toensurethattheyaresterilewhenplacedonthemarketandthat,unlessthepackagingwhichisintended

to

maintain

their

sterile

condition

is

damaged,

they

remain

sterile,

underthetransportandstorageconditionsspecifiedbythemanufacturer,untilthatpackagingisopenedatthepointofuse.Itshallbeensuredthattheintegrityofthatpackagingisclearlyevidenttothefinal

user.應(yīng)根據(jù)適當(dāng)流程，對(duì)在無(wú)菌狀態(tài)下運(yùn)輸?shù)钠餍颠M(jìn)行設(shè)計(jì)、生產(chǎn)和包裝，以確保在投放到市場(chǎng)時(shí)，及在制造商指定的運(yùn)輸和儲(chǔ)存條件下，器械能保持無(wú)菌狀態(tài)，除非旨在保持其無(wú)菌狀態(tài)的包裝遭到損壞，仍保持無(wú)菌，直至保護(hù)包裝破損或出于使用目的而打開(kāi)時(shí)。這些措施應(yīng)確保最終使用者可清晰可見(jiàn)無(wú)菌包裝的完整性。

11.5.Deviceslabelledassterileshallbeprocessed,manufactured,packagedand,sterilisedbymeansofappropriate,validated

methods.應(yīng)通過(guò)適當(dāng)?shù)慕?jīng)過(guò)驗(yàn)證的處理、生產(chǎn)、包裝和滅菌方法標(biāo)識(shí)為無(wú)菌器械。

11.6.Devicesintendedtobesterilisedshallbemanufacturedandpackagedinappropriateandcontrolledconditionsand

facilities.用于滅菌的器械應(yīng)采用適當(dāng)且可控條件和設(shè)備進(jìn)行生產(chǎn)和包裝

11.7.Packagingsystemsfornon-steriledevicesshallmaintaintheintegrityand

14cleanlinessoftheproductand,wherethedevicesaretobesterilisedpriortouse,minimisetheriskofmicrobialcontamination;thepackaging11.7

若器械在使用前滅菌，則非無(wú)菌器械的包裝系統(tǒng)應(yīng)保持產(chǎn)品的完整性和清潔度，以盡量減少微生物污染風(fēng)險(xiǎn)；此外，包裝系統(tǒng)應(yīng)適當(dāng)考慮制造商指定的滅菌方法。11.8.Thelabellingofthedeviceshalldistinguishbetweenidenticalor

similardevicesplacedonthemarketinbothasterileandanon-sterileconditionadditionaltothesymbolusedtoindicatethatdevicesare

sterile.11.8

器械標(biāo)識(shí)除帶有滅菌產(chǎn)品的指示符號(hào)外，還應(yīng)可區(qū)別市場(chǎng)上相同或相似器械的滅菌和非滅菌狀態(tài)。

12.Devicesincorporatingasubstanceconsideredtobeamedicinalproductanddevicesthatarecomposedofsubstancesorofcombinationsofsubstancesthatareabsorbedbyorlocallydispersedinthehuman

body.12

包含被認(rèn)為是藥品物質(zhì)的器械，及由人體吸收或局部噴灑在人體上的物質(zhì)或物質(zhì)組合構(gòu)成的器械。

12.1.

In

the

case

of

devices

referred

to

in

the

first

subparagraph

of

Article

1(8),

thequality,

safety

and

usefulness

of

the

substance

which,

if

used

separately,

wouldbeconsideredtobeamedicinalproductwithinthemeaningofpoint(2)ofArticle1ofDirective2001/83/EC,shallbeverifiedbyanalogywiththemethodsspecifiedinAnnexItoDirective2001/83/EC,asrequiredbytheapplicable

conformityassessmentprocedureunderthis

Regulation.

12.1

對(duì)于第

1(8)條第一子段所指的器械，若單獨(dú)使用，則該物質(zhì)的質(zhì)量、安全性和可用性將被視為是符合第

2001/83/EC

號(hào)指令第

1

條(2)點(diǎn)的醫(yī)藥產(chǎn)品，則應(yīng)按照本法規(guī)中適用的符合性評(píng)價(jià)流程的規(guī)定，使用與第

2001/83/EC

號(hào)指令附錄I

所規(guī)定方法相似的方法進(jìn)行驗(yàn)證。

12.2.Devicesthatarecomposedofsubstancesorofcombinationsofsubstancesthatareintendedtobeintroducedintothehumanbody,andthatare

absorbed

15by

or

locally

dispersed

in

the

human

body

shall

comply,

where

applicable

and

in

amannerlimitedtotheaspectsnotcoveredbythisRegulation,withtherelevantrequirementslaiddowninAnnexItoDirective2001/83/ECfortheevaluationofabsorption,distribution,metabolism,excretion,localtolerance,toxicity,interactionwithotherdevices,medicinalproductsorothersubstancesandpotential12.2

預(yù)期植入到人體，以及由人體吸收或局部噴灑在人體上的物質(zhì)或物質(zhì)組合構(gòu)成的器械，應(yīng)遵從，（適用時(shí)）并受限于本法規(guī)與第

2001/83/EC

號(hào)指令附錄

I中規(guī)定的相關(guān)要求未涵蓋方面，而這些相關(guān)要求用于按照本法規(guī)適用的符合性評(píng)價(jià)流程，對(duì)吸收、分配、新陳代謝、排泄、局部耐受性、毒性，與其他器械、醫(yī)藥產(chǎn)品呼呼其他物質(zhì)和相互影響，及副作用的潛在影響進(jìn)行評(píng)價(jià)。

13.Devicesincorporatingmaterialsofbiological

origin13.含有生物來(lái)源材料的器械

13.1.Fordevicesmanufacturedutilisingderivativesoftissuesorcellsofhumanoriginwhicharenon-viableorarerenderednon-viablecoveredbythisRegulationinaccordancewithpoint(g)ofArticle1(6),thefollowingshallapply:13.1

對(duì)于使用由本法規(guī)涵蓋的非活性或處理為非活性人源生物組織或細(xì)胞生產(chǎn)成的器械，根據(jù)第

1(6)條(g)點(diǎn)，適用以下規(guī)定：

(a)donation,procurementandtestingofthetissuesandcellsshallbedoneinaccordancewithDirective

2004/23/EC;對(duì)用于器械生產(chǎn)的人源組織和細(xì)胞的捐贈(zèng)、購(gòu)買(mǎi)和測(cè)試應(yīng)根據(jù)