TESTING,CERTIFICATION

OFPlastics

and

ElastomerFOR

MEDICAL

PURPOSE醫(yī)用塑料測試與認(rèn)證Medical

Device

ServicesSouth

China

technical

manager醫(yī)用塑料醫(yī)用塑料是指達(dá)到醫(yī)用衛(wèi)生級別的塑料，只有為數(shù)不多的幾種塑料可以做到，比如PVC、PE、PP、PET、PU等。Plastic樹脂Rubber橡膠ASTMD412-2013standard

test

method

forVulcanized

Rubber

and

Thermoplatic

Elastomers

–

Tension3.1.6

thermoplastic

elastomers—a

diverse

family

of

rubberlike

materials

that

unlikeconventional

vulcanized

rubbers

can

beprocessed

and

recycled

like

hermoplasticmaterials.熱塑性彈性體/TPE普及優(yōu)勢加工性能性能優(yōu)異成本低廉熱塑性彈性體/TPE醫(yī)用塑膠發(fā)展現(xiàn)狀起步晚，發(fā)展快，前景大今后十年醫(yī)用塑料是近年來迅速發(fā)展起來的塑料應(yīng)用領(lǐng)域，業(yè)內(nèi)中，醫(yī)用塑料領(lǐng)域?qū)⒊蔀樗芰瞎I(yè)最有發(fā)展?jié)摿Φ氖袌鲋弧ａt(yī)用塑膠發(fā)展現(xiàn)狀醫(yī)用塑膠發(fā)展現(xiàn)狀未來幾年，我國醫(yī)用塑料主要應(yīng)用方向(1)心外體外循環(huán)產(chǎn)品

(2)自體血回收產(chǎn)品(3)心臟內(nèi)科產(chǎn)品

(4)麻醉類產(chǎn)品各種新材料開發(fā)應(yīng)用氟材料導(dǎo)管：主要用于留置針導(dǎo)管、介入導(dǎo)管、各種鞘管。不含DEHP的PVC軟管。復(fù)合材料導(dǎo)管：比如避光壓力延長管、胰島素輸送導(dǎo)管等。腦導(dǎo)管。急救類器材INDUSTRIAL

APPLICATION/工業(yè)應(yīng)用Medical

device/器械應(yīng)用Surface/表面器械Implant/植入物Pharmacutical/

應(yīng)用Containerfor

injection/注射液Container

for

oral/topical/口服、局部?

SGS

SA2014S9You

supplymaterialsor

components

for

variantcompanies

supplying

following

finished

products.您的公司可能向許多成品制造商供貨。Drug

container藥包材客戶Medical

device醫(yī)療器械客戶Implant植入物客戶INDUSTRIAL

APPLICATION/工業(yè)應(yīng)用?

SGS

SA2014S10CLIENTs

MAY

NEED

A

USPⅥ

REPORT你的客戶可能向您索取USPⅥ的報告USP<88>BIOLOGICAL

REACTIVITY

TESTS,

IN

VIVO生物學(xué)反應(yīng)試驗，體內(nèi)試驗?

SGS

SA2014S11USP<88>

BIOLOGICAL

REACTIVITY

TESTS,

IN

VIVOPlastic

classes/塑料的分級Tests

to

be

conducted/要做的測試ⅠⅡⅢⅣⅤⅥTest

Material/測試對象Animal/動物模型Procedure/試驗程序●●●●●●Extractof0.9%NaClMouseA

(iv)●●●●●●RabbitB●●●●●Extractof(1:20)

Alcohol:0.9%NaClMouseA

(iv)●●●●●RabbitB●●●Extract

ofPEG400MouseA

(ip)●●RabbitB●●●●ExtractofVegetable

OilMouseA

(ip)●●●RabbitB●●Implant

strips

of

SampleRabbitCCLIENTs

MAY

NEED

A

USPⅥ

REPORT你的客戶可能向您索取USPⅥ的報告?

SGS

SA2014S12ip(腹腔)B.Intracutaneous

injection局部毒性試驗C.Implantation植入實驗CLIENTs

MAY

NEED

A

USPⅥ

REPORT你的客戶可能向您索取USPⅥ的報告A.Systemic

injection系統(tǒng)毒性試驗iv(靜脈)?

SGS

SA2014S13Mouse/老鼠Rabbit/家兔CLIENTs

MAY

NEED

A

USPⅥ

REPORT你的客戶可能向您索取USPⅥ的報告?

SGS

SA2014S14WHO

USE

USP88誰會關(guān)注USP88If

you

manufacture

plastic

containers

forinjection您是否制造注射液包材？If

you

manufacture

plastic

medical

devices您是否生產(chǎn)塑膠醫(yī)療器械？r,

manufacturers,

and

users

forcommunication

purpose您是否需要了解您的原物料安全性？You

could

be

a

material

Mfg您是否是醫(yī)療行業(yè)的原料生產(chǎn)商？You

could

be

a

component

Mfg您是否是醫(yī)療行業(yè)的半成品生產(chǎn)商？?

SGS

SA2014S15WHO

NOT

USE

USP88哪些人不關(guān)注USP88If

you

manufacture

plastic

containers

forORAL

or

TOPICAL

application經(jīng)口、局部給藥容器If

you

manufacture

natural

elastomers天然乳膠?

SGS

SA2014S16HOW

TO

ASSIGN

A

CLASS

DESIGNATION如何定義USP分級USP<1031>

,

Page

4THE PATIBILITY

OF

MATERIALS

used

indrug

containers,

medical

devices,

andimplants藥包材、醫(yī)療器械、植入物用原料的生物兼容性?

SGS

SA2014S17SurfacedeviceskinLimitedUSP

IProlongedUSP

IPermanentUSP

ImucosalLimitedUSP

IProlongedUSP

IIIPermanentUSP

VbreachedLimitedUSP

IIIProlongedUSP

VPermanentUSP

VIHOW

TO

ASSIGN

A

CLASS

DESIGNATION如何定義USP分級?

SGS

SA2014S18ExternalCommunicatingBlood

PathIndirectLimitedUSP

IVProlongedUSP

VPermanentUSP

VITissue/Bone/DentinCommunicatingLimitedUSP

IVProlongedUSP

VIPermanentUSP

VIBlood

PathDirectLimitedUSP

IVProlongedUSP

VIPermanentUSP

VIHOW

TO

ASSIGN

A

CLASS

DESIGNATION如何定義USP分級?

SGS

SA2014S19ImplantDeviceBloodLimitedUSP

VIProlongedUSP

VIPermanentUSP

VITissueLimitedUSP

VIProlongedUSP

VIPermanentUSP

VIBoneLimitedUSP

VIProlongedUSP

VIPermanentUSP

VIHOW

TO

ASSIGN

A

CLASS

DESIGNATION如何定義USP分級?

SGS

SA2014S20DECISION

TREE判定樹USP88

invivo體內(nèi)實驗Intracutaneous皮下反應(yīng)Systemic

injection系統(tǒng)毒性USP87in

vitro體外實驗Elastomer彈性體noyesOVER結(jié)束?

SGS

SA2014S21USP88

in

vivo體內(nèi)實驗Intracutaneous皮下反應(yīng)Systemic

injection系統(tǒng)毒性Implantation植入實驗USP87in

vitro體外實驗Plastics塑料DECISION

TREE判定樹?

SGS

SA2014S22HOW

TO

CONDUCT

EACH

TESTS實驗如何進(jìn)行？Surface

method/按表面積6cm2/ml3cm2/mlWeight

method/按重量0.1g

/ml0.2g

/ml?

SGS

SA2014S230.9%

NaCl生理鹽水(1:20)

Alcohol:0.9%NaCl:生理鹽水1:20PEG

400聚乙二醇Vegetable

Oil植物油HOW

TO

CONDUCT

EACH

TESTS實驗如何進(jìn)行？?

SGS

SA2014S24121℃,

60

min70℃

,

24

hours50℃

,

72

hoursHOW

TO

CONDUCT

EACH

TESTS實驗如何進(jìn)行？?

SGS

SA2014S25ANIMAL/動物模型5

mouseADMINISTRATIONIV（靜脈給藥）IP（腹腔給藥）ASSESSMENTBody

weight(體重)Abnormal

behavior(臨床)Death(

)SYSTEMICINJECTIONHOW

TO

CONDUCT

EACH

TESTS實驗如何進(jìn)行？-系統(tǒng)毒性?

SGS

SA2014S26ANIMAL動物模型5

rabbitADMINISTRATIONIntracutaneous注射ASSESSMENTErythema/紅疹Eschar/焦痂Edema/水腫INTRADERMALINJECTIONHOW

TO

CONDUCT

EACH

TESTS實驗如何進(jìn)行？-皮下反應(yīng)?

SGS

SA2014S27ANIMAL動物模型2

rabbitADMINISTRATIONImplantation肌肉4strips(10*1mm)ASSESSMENThemorrhage

/necrosis/壞死discoloration/變色I(xiàn)nfection/IMPLANTATIONTESTHOW

TO

CONDUCT

EACH

TESTS實驗如何進(jìn)行？植入實驗?

SGS

SA2014S28HOW

TOEXPRESS表達(dá)方式?

SGS

SA2014S29WHAT

CONSTITUTES

REGULATORYREQUIREMENTS要求是什么？ONLY

USPⅥ

can

not

be

sufficient.僅僅進(jìn)行USPⅥ測試是不夠的。Additional patibility

requirements

betaken

into

consideration.需要考慮其他的生物兼容項目。?

SGS

SA2014S30?

SGS

SA2014S31PERFORMANCE

REQUIREMENTS

FORINFUSION/INJECTION

SETS輸注器械的性能要求2

TECHNICAL

COMMITTEE/技術(shù)ISO/TC

84

INJECTION/注射ISO/TC

76

INFUSION/輸液(血)?

SGS

SA2014S32PERFORMANCE

REQUIREMENTS/性能要求PERFORMANCE

REQUIREMENTS

FORINFUSION/INJECTION

SETS輸注器械的性能要求?

SGS

SA2014S33PHYSICAL

PERFORMANCE/物理性能Tensile

strength拉伸強(qiáng)度Elongation伸長率LeakageSterilization

suitability耐蒸汽Ageing耐老化Particle

contamination微粒污染Kinking扭結(jié)實驗Thermal

stability熱沖擊(穩(wěn)定)water

vapor

tr