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医用硅胶在人体植入和非植入领域的必看之选

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发布时间 : 2019/05/15 | 文章来源 : NUSIL | 作者 : 易供应

医用硅胶在人体植入和非植入领域的必看之选

Premium Care& Class VI lines

医用硅胶在人体植入和非植入的应用01


Medical-grade silicones 医用硅胶 医疗级硅树脂


COMMITMENT TO CARE AND INNOVATION
For more than 30 years, the NuSil™ brand has been
continuously supplying medical device manufacturers with
silicones of the highest purity and long-term stability for
general healthcare applications. Our market-leading, medicalgrade
silicones for use in and on the body are trusted to help
save and improve the quality of life worldwide.
30多年来,NuSil™品牌一直致力于关怀和创新,不断向医疗器械生产厂家提供
具有最高的纯度和长期稳定性的医用硅胶。我们领先市场,提供用于身体内外的医用硅胶,

被认为可有效的拯救和改善世界各地人们的生活质量。

Industry leaders depend on the quality, purity and reliability of
our silicones for a wide range of life-saving and life-enhancing
medical devices and healthcare products.
行业的领导者依赖于产品的质量、纯度和可靠性我们的医用硅胶

为广泛的生命拯救和提高生命医疗器械和保健产品。

医用硅胶在人体植入和非植入的应用02

MEDICAL-GRADE SILICONES 医用硅胶

All of our medical-grade silicones are specifically designed,
manufactured and purified to meet the strictest requirements
of the healthcare industry. These products are made under
applicable cGMP standards in facilities indirectly or directly
regulated by the U.S. Food and Drug Administration and are
typically supported with Master Files.
我们所有的医用硅胶都是专门设计的,制造和纯化以满足最严格的要求
医疗保健行业。这些产品是在间接或直接适用于设施的cGMP标准
由美国食品和药物管理局监管,均由主文件支持。

Applications 应用

We leverage our insight into the unique performance
characteristics of high-purity silicones to help medical device
manufacturers explore and expand their use into multiple
therapeutic applications.
我们利用我们对独特性能的洞察力特点为高纯度硅酮助医疗器械
制造商探索并将其应用扩展到多个领域治疗应用。

Leading applications for NuSil Premium Care and Class VI silicones include:

主要应用于NuSil高级护理和四类有机硅包括:
‒‒Needle coatings
‒‒ IV sets
‒‒Airway management
‒‒Catheters
‒‒Wound care and scar management
‒‒Prosthetics
‒‒Surgical tools and robotics
‒‒针涂料
‒‒IV sets
‒‒气道管理
‒‒导管
‒‒伤口护理和疤痕管理
‒‒假肢
‒‒手术工具和机器人

医用硅胶在人体植入和非植入的应用03
Premium Care & Class VI products

优质护理 & VI类产品
Our Premium Care medical-grade silicones provide proven solutions for
general healthcare applications requiring something beyond standard
offerings, such as product customization, specialized packaging and/
or a higher level of regulatory support. Our Class VI portfolio includes
high-value, readily available products that deliver cost efficiencies,
standard packaging and testing necessary for high-volume production
applications. Both lines are designed for use in medical applications
that are not implanted for greater than 29 days.
我们的优质护理医用硅胶提供证明的解决方案
一般医疗应用程序需要超出标准的产品,

如产品定制,特殊包装和/或者更高层次的监管支持。

我们的第VI类投资组合包括:
高价值、易得、成本效益高的产品,高产量生产所需的标准包装和测试
应用程序。这两条生产线都是为医疗应用而设计的植入时间不超过29天。

液体硅胶橡胶
LIQUID SILICONE RUBBERS
Liquid silicone rubbers (LSRs) are
designed for liquid injection molding
and provide an excellent material for
precision molded components, such as
O-rings, gaskets, valves and seals.
液体硅胶橡胶(LSRs)
适用于液体注射成型
提供了很好的材料
精密注塑件等
o形环,垫圈,阀门和密封件。

高一致性橡胶
HIGH CONSISTENCY RUBBERS
High consistency rubbers (HCRs) are
strong silicone materials well-suited for
fabrication processes, such as extruding,
calendering and compression or transfer
molding into a wide range of parts.
NuSil's HCR portfolio features both
peroxide and platinum cure systems.

高稠度橡胶(HCRs)
坚固的有机硅材料非常适合
制造过程,如挤压,
压延和压缩或转移
成型成各种各样的零件。
NuSil的HCR投资组合具有这两个特点
过氧化氢和铂固化体系。
低粘度弹性体和分散液

LOW VISCOSITY ELASTOMERS
AND DISPERSIONS
Low viscosity elastomers provide a
flowable silicone that can be used to
encapsulate a device or be low-pressure
molded into a part. Dispersions are
ideal for processes where the silicone is
applied as a thin film coating or for dip
molded parts.
高一致性橡胶低粘度弹性体提供了一个低粘度弹性体
和分散低粘度弹性体提供了一个可流动硅胶,

可用于封装一个设备或低压铸成零件。

乳液适用于硅树脂加工用作薄膜涂层或浸渍成型部分。

粘合剂和引物

ADHESIVES AND PRIMERS
Our silicone adhesives range from
adhesive elastomers for permanent
bonding to temporary adhesives, such
as soft silicone adhesives or pressure
sensitive adhesives. Our primers can be
applied to substrates to improve adhesion.
我们的硅树脂胶粘剂范围从
永久性粘接弹性体
与临时粘合剂等粘合
如软硅胶或压力胶
敏感的粘合剂。我们的引物可以
适用于基材,以提高附着力。
润滑剂

LUBRICANTS
Silicone lubricants are used to reduce
friction within device components or
against human tissue.
硅酮润滑油是用来减少
设备部件内部的摩擦或
对人体组织。

特种材料
SPECIALTY MATERIALS
Our specialty materials include
radiopaque masterbatches, as well as
silicone marking inks and foams.
我们的专业材料包括
以及不透明色母粒
有机硅标记油墨和泡沫。

REGULATORY SUPPORT 管理支持
For over three decades,  we have been helping medical device companies obtain
regulatory clearance for their products. That commitment extends well beyond the
sale of our silicones. We provide the technical and regulatory expertise needed
for approval and are willing to communicate directly with international regulatory
authorities on behalf of our customers.
30多年来,我们一直在帮助医疗设备公司获得
他们产品的监管许可。这一承诺远远超出了
销售我们的硅酮。我们提供所需的技术和监管专业知识
并愿意与国际监管机构直接沟通
当局代表我们的客户。
NuSil maintains over 700 Master Files (MAFs) with the United States Food & Drug
Administration (FDA) in support of our Premium Care and Class VI products. A
critical element of the MAF is the biological testing performed on the majority of
products in our portfolio.
NuSil与美国食品和药品公司保持着700多个主文件(MAFs)
管理(FDA)支持我们的优质护理和第VI类产品。一个
MAF的关键因素是对大多数进行的生物检测
我们产品组合中的产品。
医用硅胶在人体植入和非植入的应用07

医用硅胶在人体植入和非植入的应用08

CUSTOMIZATION MASTERED 定制掌握
We know that standard solutions don’t always fit. That’s why we create
customized products based on our customers’ unique applications. And
after three decades of serving the most demanding industries, we’ve
honed our processes and proprietary equipment to take customization
to a mass scale.
NuSil has the ability to customize products and packaging according
to individual requirements for an array of convenient options that meet
our customers’ needs. We have over 3,000 standard products that can
be customized to very unique specifications.
我们知道标准的解决方案并不总是合适的。这就是我们创造的原因
根据客户独特的应用定制产品。和在为最苛刻的行业服务了30年之后,

我们已经磨练我们的工艺和专有设备,承接定制大规模地。
NuSil有能力定制产品和包装根据
为满足个人需求提供一系列方便的选项我们客户的需求。

我们有3000多种标准产品,可定制非常独特的规格。


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