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原材料

Resins Used

国产医用

Domestic

进口医用

Imported

进口医用

Imported

进口医用

Imported

质量指标Specification

外观Appearance

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尺寸Size

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容积Capability

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密封性Leakproof

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跌落性能Drop resistant

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微生物限度

Microbiological Purity

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无菌Sterility

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无热源（内毒素）Endotoxin

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无人类DNA

Free human-DNA

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无DNase/RNase

Free DNase/RNase

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原材料

Resins Used

国产医用

Domestic

进口医用

Imported

进口医用

Imported

进口医用

Imported

食品接触塑料制品法规Regulation on Food Contact for Plastics and Articles

欧盟：10/2011/EC (PIM)及修订版

European Union: 10/2011/EC (PIM)

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美国：FDA 21 CFR 177.1520

United States: FDA 21 CFR 177.1520

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中国：GB4806.7-2016

China: GB4806.7-2016

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药典符合性Pharmacopeia Complies 

USP 39  <661>塑料容器

USP 39  <661> Containers

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EP 9.0章节3.1.3聚乙烯类产品

EP 9.0 Chapter 3.1.3Polyolefins

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EP 9.0章节3.1.5注射用和滴眼用聚乙烯类产品EP 9.0< 3.1.5>Polyethylene with additives for containers for parenteral preparations and for ophthalmic preparations

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生物相容性Biocompatibility

ISO 10993-5细胞毒性

ISO 10993-5 Cytotoxicity

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ISO 10993-10皮刺和致敏试验

ISO 10993-10 Irritation and Sensitization tests

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ISO 10993-11系统毒性试验

ISO 10993-11 Acute Systemic Toxicity Test

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USP <85>内毒素测试

USP <85> Bacterial Endotoxins-LAL test

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USP <87>体外生物反应测试

USP <87> Biological reactivity testing, in vitro

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USP <88>体内生物反应测试

USP <88> Biological reactivity testing, in vivo, class VI

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原材料

Resins Used

国产医用

Domestic

进口医用

Imported

进口医用

Imported

进口医用

Imported

动物来源Animal Origin

TSE/BSE申明

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过敏源

Allergen

无过敏源申明

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杂质Elemental Impurity

ICH Q3D

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环境影响Environment Impact

ROSH

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REACH

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密封完整性Leakproof

产品经确认，密封性能完整。

Leakproof as validation

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颗粒 Particulates

USP <788>和EP 2.9.19

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溶出物 Extractables

USP <661>塑料制容器

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灭菌 Sterilization

产品经辐照，满足无菌要求（SAL=10^-6）。

Meet the sterility level(SAL=10^-6) after irritation.

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