YY/T 1119-1999 医用高分子制品术语

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备案号:3053-1999

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中华人民共和国医药行业标准

YY/T1119-1999

医用高分子制品术语

Terminologyrelatingtomedicalpolymerproducts

1999一06一07发布1999一10一01实施

国家药品监督管理局发布

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前言

本标准是在ZBC49005-1989K医用高分子制品术语》的基础上修订的本标准对医用高分子制品

术语进行了补充，对各章重新进行了编排，对术语重新进行了调整，取消了原标准中的人工器官类术语。

本标准的附录A、附录B是提示的附录。

本标准从生效之日起，同时代替ZBC48005-19890

本标准由国家药品监督管理局提出。

本标准负责起草单位:国家医药管理局医用高分子产品质量检测中心。

本标准主要起草人:吴平、田青。

中华人民共和国医药行业标准

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医用高分子制品术语代替ZBC48005-1989

Terminologyrelatingtomedicalpolymerproducts

范围

本标准规定了医疗器械制品中主要由医用高分子材料组成，且直接或间接作用于人体的制品术语。

本标准不包括人工器官术语。

基本术语

2.1导管catheter

经穿刺术或切开术插入人体的软管。

2.2管路tube

不插人人体组织，但可与人体粘膜接触使用的软管。

2.3擂管cannula

将其插入肠道、食道、呼吸道或其他部位的软管，通过它向体内输入药液、营养液及气体或排出体

内液体。

2.4可显影导管radiopaquecatheter

不透X线，以便临床监视的导管。

2.5造影导管angiographiccatheter

向体内某部位输送显影剂的导管。

2.6注射座injectionsite

可通过它向里注射药液且具有自密封性的装置。

2.7阀valve

管路上靠流体原理使管路关闭或打开的装置，分单向阀和双向阀。

2.8开关cock

以手动或机械方式使管路关闭、打开或转换通路的装置。

2.9流皿调节器flowregulator

用于调节流量的装置。

2.10(球)班mil

固定在导管或擂管上，充液或充气后鼓起，用于扩张管脉、使器械定位或止血的弹性件。

2.11球ball

捏扁后排出、释放后吸入液体或气体(常鼓)的弹性件。

2.12腔(路)lumen

导管的管路内部。

2.13接头fitting

用于将导管与管路连接或将管路与管路连接的装置。分为外圆锥接头(出液端)和内圆锥接头(进

国家药品监督管理局1999一06一07批准1999-10一01实施

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液端)，最常见的是6:loo(鲁尔)圆锥接头。

引流管drain

靠患者体内流体压力，将脓液、渗出液或其他代谢物引出体外的插管或导管。

分流器shunt

将体内某部位不希望有的体液分流到人体其他部位的装置。

吸引管suctiontube

负压管suctiontube

通过负压作用把人体内某部位积液或组织吸出体外的管路。

2.17滴斗dripchamber

需要精确控制流量的管路上，用于观察流量大小的装置。其特点是其进液口有一个能形成液滴的

滴管。

过滤器filter

用于过滤气体、液体中不需要的物质的装置。常由壳体和滤材组成。

分离器separator

通过膜分离或离心作用，将液体中的不同成分分离开的装置。

泵管pumptube

用于与蠕动泵配合，使系统内部液体流动的高弹性软管。

血路tubeforbloodflow

输送血液或血液成分的管路

2.22循环血路tubeforbloodcirculation

体外循环的血路(血液在管路中单向流动)。

回输血路tubeforbloodreturn

能从患者或献血者体内采出血液，并将处理后的血液或血液成分回输给患者或献血者的管路的

统称(血液在管路中双向流动)。

导管

3.1外周血管内导管peripheralintravascularcatheter

用于从外周血管内将液体或器械引人或引出的导管。一般导管较短，套在一根穿刺针上，以便将导

管送入外周血管，故又称套针外周导管。

3.2中心静脉导管centralvenouscatheter

插入中心静脉系统，用于监测压力、输人药液、营养液或取出血样的血管内导管。分单腔或多腔。

3.3动脉导管arterialcatheter

用于动脉压力监测或取血样的血管内导管。

3.4球囊扩张导管balloondilatationcatheter

末端附近有一球班，充起后用以扩张血管/心瓣膜或输入药液或取血样的血管内导管。

3.5血管成形导管angioplastycatheter

用于扩张血管狭窄部位的球襄扩张导管。

3.6瓣膜成形导管valvuloplastycatheter

用于扩张瓣膜狭窄的球琪扩张导管。

3.7PTCA球级扩张导管percutaneoustransluminalcoronaryangioplastyballoondilatation

catheter

经皮经冠状动脉成形术用血管成形导管。

3.8栓塞切除导管embolectomycatheter

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用于将血管内栓塞切除并取出的导管。

9腹膜透析管peritonealdialysiscatheter

供肾功能衰竭患者使用，通过腹壁至腹膜用透析液进行腹膜透析的导管。

10导尿管urethralcatheter

通过尿道插入患者膀胧向体外导尿的导管。

11硬膜外麻醉导管epiduralanestheticcatheter

用于向硬膜外腔输送麻醉剂的导管。

12脑积水分流器hydrocephalusshunt

植人患者体内将脑积水引入体内其他部位的导管装置。

13植人式给药装置implantabledrugdeliverysystem

植入患者体内，可经皮向其注射座内注射药物并通过导管将药物输送到病变部位的装置_

一般器具

4.1输液器infusionset

与静脉穿刺针配合，将药液向患者静脉内输送的器具。

4.2滴定管式输液器burettetypeinfusionset

能精确计量输液剂量的输液器。

4.3静脉输液针intravenousneedle

将精液器与患者静脉连接的一种静脉穿刺器具。常见的其尾部有一段细的软管。

4.4输血器transfusionset

与静脉穿刺针配合，将血液或血液成分向患者静脉内输送的器具。

4.5采血器blood-takingset

从献血者或患者体内采出血液的器具

4.6注射器hypodermicsyringe

与注射针配套，经皮向体内注射药液的器具。

4.7胰岛素注射器hypodermicsyringeforinsulininjection

与注射针配套，经皮向体内注射胰岛素的注射器。

4.8气管播管tracheacannula>endotrachealtube

插入患者气管内输送氧气和麻醉气体的软管。

4.9胃管stomachtube

通过食管向胃内输送或从胃内输出液体的软管。

4.10鼻饲管nasalfeedingtube

从鼻腔、食道插人，灌注流质食物的软管。

4.11肛管anustube

向直肠内输送液体或通过直肠输出排泄物的软管。

4.12灌肠器enemaset

从肛门插入直肠作灌肠通便用的器具。

4.13微f采血吸管blood-takingmicro-tube

从指尖采集微量血样，供化验用的器具。

4.14血液过滤器bloodfilter

血路上用以过滤血液中凝血块的装置。

4.15药液过滤器liquidfilter

输液器上用以过滤药液中不溶性粒子的装置。

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白细胞过滤器leucocytefilter

能大量滤除输用血液中白细胞的装置。

4.17空气过滤器airfilter

装在输血、输液器具的通气口上，用以过滤进入系统的空气中的尘埃微生物。

血桨分离器plasmaseparator

通过离心或膜分离作用，将血浆或血浆成分从血液中分离出来的装置。

4.19阴道扩张器vaginadilator

用于扩张阴道做妇科检查用器械。

20外科手套surgicalgloves

手术用手套，用天然橡胶胶乳制成。

检查手套examinationgloves

医生检查用手套，用橡胶或塑料制成。

检查指套examinationfinger-cot

医生检查用指套，用橡胶制成。

避孕套condom

男用橡胶避孕筒状隔离器具。

避孕隔膜femalecontraceptivediaphragm

膜状女用避孕隔离器具。

容器

血袋collapsiblecontainerforhumanblood

供人体血液采集、分离、贮存及输注用塑料容器。主要由采血袋和转移袋组成。

血疗袋bloodbagforirradiatingwithUVrays

光量子血袋bloodbagforirradiatingwithUVrays

将采集到的病人血液进行紫外线照射的软质容器。

5.3静脉血样采集容器containerforvenousbloodspecimencollection

与穿刺针等辅助器具配合使用，从静脉采集血样供化验分析用的容器。分为抽真空和非抽真空两

类。

引流袋drainbag

贮存引流液的软质容器。

集尿袋urinecollectionbag

通过导尿管或管路收集患者排泄尿液的软质容器。

肛门袋anusbag

通过肛管或痊管收集患者排泄物的容器。

静脉营养输液袋venousinfusionbagfornutrientsolution

通过输液器、中心静脉导管等器具直接向病人大静脉内输送营养液的容器。

腹膜透析袋bagforperitonealdialysisliquid

装腹膜透析液，通过插入肾功能衰竭患者腹腔的腹膜透析管进行透析的容器。

6生物材料及制品

6.1可吸收材料absorbablematerial

可以在人体内被降解为无害可吸收的高分子材料分为合成材料和生物提取材料两类。

6.2高吸水性材料superhygroscopicitymaterial

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具有高吸水性能的材料。

6.3透明质酸钠hyaluronicacid

以生物组织提取法或细菌发酵法制得的由葡萄糖醛酸和氨基葡萄糖单元反复交替连接而成的聚

糖。

6.4整复材料restitutionmaterial

用于整容或修复，可长期植于人体内的材料的总称。如人工血管、人工乳房、人工颅骨等。

6.5止血海绵hemostaticsponge

从生物组织中提取的明胶、甲壳质或胶原蛋白等加工而成的外科止血用发泡状生物材料。分可吸

收和不可吸收。

6.6明胶gelatin

动物的皮、骨、健与韧带中含有的胶原，经部分水解后得到的一种制品(变性胶原)。

6.7明胶海绵gelatinsponge

明胶溶于水，经打泡、冷冻、干燥、灭菌制得的发泡状可吸收止血材料。

6.8胶原蛋白海绵collagenproteinsponge

幼小动物皮中含有的胶原(不变性手段提取)，经低温提取、冷冻、干燥、灭菌制得的发泡状可吸收

止血材料。

6.9药物缓释材料drugsustained-releasematerial

药物经物理或化学作用而固定在高分子基质上，植人后药物缓慢向体内释放的材料。

6.10缝线suture

用生物提取材料、合成材料或蚕丝等制成的手术缝线。从性能上分可吸收和不可吸收;从结构上

分为单丝和编织以及带针和不带针。

6.11可吸收手术缝线absorbablesuture

用生物大分子或合成可吸收聚合物制成，植入活组织中能被组织代谢吸收的手术缝线。

6.12不可吸收手术缝线non-absorbablesuture

用动物、植物或合成材料等制成，植人活组织中不能被组织代谢吸收的手术缝线。

6.13肠线catgut

从哺乳动物肠膜上提取的胶原物质制得的可吸收手术缝线。

6.14医用粘合剂medicaladhesive

用生物提取或合成技术制得的用于组织粘连的材料。分单剂型和多剂型。

6.15丙烯酸树脂枯合剂acrylicresincements

以聚甲基丙烯酸醋为主要成分的自凝树脂粘合剂。粉剂和液剂调合后在应用部位固化。

6.16光固化材料light-setmaterial

在应用部位受冷光源照射后发生固化的粘合材料。

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附录A

中文索引

(提示的附录)

光固化材料·································……6.16

光量子血袋······························……5.2

白细胞过滤器·····························……4.16过滤器·······································……2.18

瓣膜成形导管······························……3.6

泵管.·2.20

鼻饲管···································……4.10回输血路········‘·······················……2.23

避孕隔膜····································……4.24

避孕套······································……4.23

丙烯酸树脂粘合剂集尿袋·········································、……5.

不可吸收手术缝线:.:;胶原蛋白海绵·······························.·……6.8

检查手套···································……4.21

检查指套.·4.22

采血器·······································……4.5接头········································。·……2.13

插管············································……2.3静脉输液针···································……4.3

肠线······································……6.13静脉营养输液袋··················”·····.·..·……5.

静脉血样采集容器·····”·”·······…·…，……5.

导管···········································……2.1

导尿管·。···································。。。··…3.10开关····。。·······································……28

滴定管式输液器·····························……4.2可吸收材料·····································。·…6.1

滴斗.·2.17可吸收手术缝线····················……·‘·…6.11

动脉导管··································。····……3.3可显影导管···································……2.4

空气过滤器·································……4.17

阀···············································……2.7

分离器·······································……2.19流量调节器············.·，········，··········“……2.

分流器·····································……2.15

缝线··，······················。···············……6.10

负压管·························。········，····……2.16明胶······················。··················。·····，…6.

腹膜透析袋·································……5.8明胶海绵·······································……6.

腹膜透析管··································……3·9

脑积水分流器3.12

肛管········································……4.11囊2.10

肛门袋·········································……5.6

高吸水性材料6.2

灌肠器4。12气管插管········.·················。············……4.

管路…腔2.

6

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球公血疗袋·········································……5.2

球囊扩张导管···……血路························。·············……2.21

PTCA球囊扩张导管血液过滤器一4122

循环血路·

输血器·········································……4·

输液器··········································……4·药液过滤器································……4.51

栓塞切除导管······························……二‘4·药物缓释材料································……6.9

胰岛素注射器·································……47

医用粘合剂·································……6.41

透明质酸钠恢3阴道扩张器··············‘····，，·，········‘·…4.91

引流袋··········································。·…5.4

W

引流管··············。························……2.41

外科手套················。。·················……4.02硬膜外麻醉导管······················.·.··……3.11

外周血管导管······。·。························……3.1

胃管···············································，…4.9

微量采血吸管······························……4·13造影导管··································.·，·……2，5

植入式给药装置·························……3.13

整复材料·····································……6.4

吸引管·······································……2.61止血海绵······································……6.5

血袋·············································……5.1中心静脉导管·································……3.2

血管成形导管······························……’二3·5注射器···········································一·4.6

血浆分离器································…·…4·81注射座········································……2.6

附录B

英文索引

(提示的附录)

absorbablematreail··············································································4·········.····……61

absorbablesuture····························································································一·6.11

arcyhcresincements··························································································……6.15

airfliter··············································································。··························……4.17

angoirgaphicacthetre·························································································……2.5

anglopaltsycatheter·······················，·······························································...···……35

anusbag·········································································································一·5.6

anusutbe··········。···························。····。····················。··。··························。······……4.n

arterialcatheter································································································……3.3

bagofrPeriotnaeldialysisliquid····································……·‘··········……’二·‘·…二‘二‘二‘’二5·

7

YY/T1119-1

ball2.11

balloon··。···············。··················。。·········.···2.10

balloondilatationcatheter3.4

bloodbagforirradiatingwithUVrays·······································，·······················……’二5.2

bloodfilter4

blood-takingmicro-tube4.::

blood-takingset

burettetypeinfusionset···················································································……

C

cannula

catgut

catheter··。······.··················‘·······。··········.·。·····。···············，·..···········.·············..……

centralvenouscatheter

cock

collagenproteinsponge

collapsiblecontainerforhumanblood

condom

containerforvenousbloodspecimencollection

D

drain···2.14

dripchamber2.17

drainbag5.4

drugsustained-releasematerial6.9

E

embolectomycatheter·……3.8

endotrachealtube4.8

enemaset...……4.12

epiduralanestheticcatheter3.11

examinationfinger-cot4.22

examinationgloves一4.21

F

femalecontraceptivediaphragm4.24

2.18

ffiitltteinrg2.13

flowregulator2.9

G

gelatin6.6

gelatinsponge6.7

YY/T1119-1999

H

hemostaticsponge

hyaluronicacid························……

hydrocephalusshunt·…，.·...·..·.……

hypodermicsyringe················……

hypodermicsyringeforinsulininjection

I

infusionset

implantabledrugdeliverysystem

nijectionstie····。。···……。·。。……

intravenousneedle

L

J

leucocytefilterq

A

liquidfilter‘.::

light-setmaterial

lumen:.::

M

medicaladhesive6.14

N

nasalfeedingtube:::‘

non-absorbablesuture

P

percutaneoustransluminalcoronaryangioplastyballoondilatationcatheter3.7

peripheralintravascularcatheter3.1

peritonealdialysiscatheter······························.·..·.·.·.·..·..·..·...……3.9

plasmaseparator4.18

pumptube2.20

R

radiopaquecatheter2.4

restitutionmaterial6.4

S

separator.一2.19

shunt2.15

stomachtube4.9

suctiontube2.16

9

YY/T1119-1999

superhygroscopicitymaterial6.2

surgicalgloves

suture:::

T

tracheacannula··。。································································。。·······。············。········……4.8

transfusionset·······················。。·。····。·····。··············。。·············。···。····························。。…4.4

tube·····················。···。··。······。···········································································……2.2

tubeforbloodcirculation···························································