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ISO 7886-1喂食器检测方案

2017-08-14 15:04:01 精邦科技發展(香港)有限公司 阅读

Title: NeoConnect Enteral and Pharmacy Syringe Inspection Specification

NeoConnect 喂食器产品检验规格


产品在ISO 7886-1 所述的器身密合性测试过程中,不能有漏液


6.3.15

Air leakage compliant to ISO 7886-1

产品在ISO 7886-1 所述的器身密合性测试过程中,不能漏气

Critical 致命

6.3.16

For 100ml vented syringe ,time to drain 100ml water should be less than 120 second

对于100ml喂食器,流出100ml 水的时间应不超过120

For 20ml vented syringe ,time to drain 20ml water should be less than 30 second

对于20ml喂食器,流出20ml 水的时间应不超过30

Major 严重

6.3.17

Force to separate plunger from barrel should be:芯杆拔出力,根据下表对应的规格确定:

SizeForce0.5-3mL2-10N6-12mL4-40N20mL5-45N20v-60mL20-60N100mL25-70N


Major 严重

6.3.18

Force to separate tip cap from tip should be > 10 Newton under a speed of 10mm/min.

10毫米每分钟的速度将帽盖从锥头中分离的力必须大于10N

Major 严重

6.3.19

Sterile syringe tip should be compatible with small bore male enteral connectors per ISO80369-3

灭菌喂食器的锥头与标准的公接头相兼容

Critical 致命

6.3.20

Pull plunger to barrel nominal capacity ,sealed barrel tip by tip cap ,push plunger to 40% nominal capacity,

NeoConnect syringe tips shall not leak while immerse syringe into water

灭菌喂食器的接头被帽盖密封时不会漏气

Major 严重

6.3.21

NeoConnect syringe tips shall have adequate resistance to stress cracking per ISO 80369-3 and ISO 80369-20

按照ISO 80369-3  ISO 80369-20要求进行应力开裂测试,NeoConnect版喂食器锥头不能有应力开裂现象

Critical 致命

6.3.22

 

NeoConnect syringe tips shall not separate from the reference connector applied axial force per ISO 80369-3 and ISO 80369-20

按照ISO 80369-3  ISO 80369-20要求进行抗轴向载荷分离力测试,NeoConnect版喂食器锥头不能与标准接头有分离现象

Critical 致命

 

6.3.23

 

NeoConnect syringe tips shall not separate from the reference connector applied unscrewing torque per ISO 80369-3 and ISO 80369-20

按照ISO 80369-3  ISO 80369-20要求进行抗旋开扭矩测试,NeoConnect版喂食器锥头不能与标准接头有分离现象

Critical 致命

6.3.24

NeoConnect syringe tips shall not override the threads or lugs of the reference connector applied torque of between 0.15N•m to 1.17N•m per ISO 80369-3 and ISO 80369-20

按照ISO 80369-3  ISO 80369-20要求进行抗过载性测试,NeoConnect版喂食器锥头不能越过被试接头的螺纹或凸耳

Critical 致命

6.3.25

NeoConnect syringe tips shall separate from the reference connector applied unscrewing torque less than 0.26N•m per ISO 80369-3 and ISO 80369-20

按照ISO 80369-3  ISO 80369-20要求进行最小旋开扭矩测试,分离扭矩不超过0.26N•m

Critical 致命

6.3.26

NeoConnect syringe tips shall not leak applied pressure of between 300kPa and 330kPa per ISO 80369-3 and ISO 80369-20

按照ISO 80369-3  ISO 80369-20要求进行漏液滴落测试,在300kPa~330kPa 力下,不能有漏液。

Critical 致命

6.3.27

For 20ml vented syringe ,hanging feature on plunger shall have a tensile strength exceeding 30N for a force perpendicular to the plunger,applied at the midpoint of the hanging feature.

20ml vented喂食器的悬挂结构应该能够承受大于等于30N的垂直力

Critical 致命

6.3.28

Enteral Syringe only : Syringe can be recognized by infusion pump properly based on its nominal capacity for applicable

Syringe sizes.

一次性肠道喂食器在公称容量的状态下与输液泵配合使用,要能被液压泵识别。

Major 严重

 

 


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