原?材?料

Resins Used

國產(chǎn)醫(yī)用

Domestic

進口醫(yī)用

imported

進口醫(yī)用

imported

進口醫(yī)用

imported

質(zhì)量指標(biāo)

Specification

外觀?Appearance

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尺寸?Size

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容積?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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無菌Sterility

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無熱源（內(nèi)毒素）Endotoxin

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無人類DNA

Free human-DNA

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無DNase/RNase

Free DNase/RNase

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原?材?料

Resins Used

國產(chǎn)醫(yī)用

Domestic

進口醫(yī)用

imported

進口醫(yī)用

imported

進口醫(yī)用

imported

食品接觸塑料制品法規(guī)

Regulation?

歐盟：10/2011/EC (PIM)?及修訂版

European Union: 10/2011/EC (PIM)

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美國：?FDA 21 ? CFR 177.1520

United ? States: FDA 21 CFR 177.1520

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中國：GB4806.7-2016

China: GB4806.7-2016

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藥典符合性

Pharmacopeia ? Complies?

USP 39? <661>?塑料容器

USP 39? <661> Containers

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EP 9.0?章節(jié)3.1.3?聚乙烯類產(chǎn)品

EP 9.0 ? Chapter 3.1.3?Polyolefins

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EP 9.0章節(jié)3.1.5?注射用和滴眼用聚乙烯類產(chǎn)品?EP 9.0< 3.1.5>?

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生物相容性

Biocompatibility

ISO 10993-5?細胞毒性

ISO 10993-5 Cytotoxicity

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ISO ? 10993-10?皮刺和致敏試驗

ISO 10993-10 Irritation ? and Sensitization tests

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ISO 10993-11系統(tǒng)毒性試驗

ISO 10993-11 Acute Systemic Toxicity Test

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USP ? <85>?內(nèi)毒素測試

USP <85> Bacterial Endotoxins-LAL test

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USP <87>?體外生物反應(yīng)測試

USP <87> Biological reactivity testing, in vitro

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USP ? <88>?體內(nèi)生物反應(yīng)測試

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

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原?材?料

Resins Used

國產(chǎn)醫(yī)用

Domestic

進口醫(yī)用

imported

進口醫(yī)用

imported

進口醫(yī)用

imported

動物來源

Animal Origin

TSE/BSE?申明

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過敏源

Allergen

無過敏源申明

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雜?質(zhì)

Elemental Impurity

ICH Q3D

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環(huán)境影響

Environment Impact

ROSH

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REACH

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密封完整性

Leakproof

產(chǎn)品經(jīng)確認记某，密封性能完整司训。

Leakproof ? as validation

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顆粒 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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滅菌 Sterilization

產(chǎn)品經(jīng)輻照，滿足無菌要求（SAL=10^-6）。

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

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