出版物: 2021 年 1 月 25 日最近更新時間: 2025 年 3 月 3 日

应用于医疗设备的柔软触感TPE

凯柏胶宝®是优质 TPE 化合物领域享誉世界的知名企业。公司供应的热塑宝 M 系列 TPE 材料具有柔软的触感和表面效果，使其成为医疗设备产品的优选材料。

无论是家用还是用于医疗机构，医疗设备必须具备极高的准确性和精度，才能为患者提供高效的治疗效果。因此，这些设备的设计必须符合人体工学的需要，便于在使用过程中实现灵活性、控制性和舒适性。

产品采用柔软触感表面可提高易用性，更具可控性和夹持力，尤其适合手持式或一次性使用的医疗设备。对于在家中进行的自我护理，柔软表面可以确保患者正确轻松地处理医疗设备，提高用药效率，避免出现错误。

如今，热塑性弹性体（TPE）因其柔软表面和触感，已得到广泛应用。此外，TPE 用于医疗设备制造可实现不同的机械性能（如易于着色、柔韧性和纯度），有助于提高产品的美观度和可用性。

对于制造商而言，TPE 可通过多种方式轻松加工（例如可通过注塑或挤压工艺制造），是非常理想的材料选择。

凯柏胶宝®是全球领先的 TPE 制造商，为各行各业提供各类热塑性弹性体产品，高品质定制热塑宝 M 解决方案，满足医疗器械行业对产品柔软触感的要求。

采取安全的方法

对于需要柔软触感表面的医疗设备，凯柏胶宝®提供的热塑宝 M 系列 MC/AD/PA 化合物可通过多种方法进行消毒，比如 EtO 气体、γ 射线处理（2 x 35 kGy）和 β 射线（电子束）处理（2 x 35 kGy）。并且热塑宝 M 系列不含乳胶、PVC 和邻苯二甲酸盐，可安全用于医疗设备。

热塑宝 M 专为需要医疗许可的应用而量身打造，符合 ISO 10993-5（细胞毒性）和 ISO 10993-10（皮内刺激）等标准。

MC/AD/PA 系列TPE对各种聚酰胺（例如 PA6 和 PA12）具有出色的包胶性，可用于制作医疗设备的柔软触感把手、密封件、柔性连接器、开关和垫子等部件。该款化合物还可用于制作具有柔软触感表面的医疗设备手柄、按钮和闭合件。

可以使用潘通色卡和 RAL 作为参考色对化合物进行多种着色，让终端产品更与众不同。

符合严格标准

凯柏胶宝®的热塑宝 M MC/tl 系列已通过了 ISO 10993-10（皮内刺激）、ISO 10993-5（细胞毒性）、ISO 10993-4（溶血）、ISO 10993-11（急性全身毒性）和 VDI 2017 认证。

它本身为自然色，可通过多种方式着色。它对 PP 和 PE 具有出色的包胶性，可用于制作吹嘴或医疗设备上的柔软触感组件。

MC/tl 系列已进行压缩永久变形优化，具有出色的耐磨性，适用于接触和摩擦频繁的应用环境，例如医疗设备上的手柄和把手以及呼吸面罩上的密封件。

医疗服务包

凯柏胶宝®可以针对客户需求提供卓越的服务包，全力以赴保障产品标准。公司通过在药物主文件（DMF）中持续记录制造过程来实现这一目标；通过供应商承诺保证 24 个月的供应安全性和原材料纯度。

公司还配备了专门用于制造热塑宝 M 产品的专用生产区域，确保化合物的高质量、安全性和可靠性。

Medical devices with TPE’s soft-touch advantage

KRAIBURG TPE, a recognized global leader in superior TPE compounds, provides the THERMOLAST® M TPE compounds for a soft-touch feel and surface in medical device applications.

With accuracy and precision, medical devices, whether used in a home or in a healthcare setting, are expected to provide effective outcomes for a patient. The design of the instruments must, thus, be ergonomically driven to enable dexterity, control and comfort when handling the instruments.

A soft-touch surface promotes ease of use, and better control and grip, especially in hand-held or single-use medical devices. For self-administering in the home, a soft-touch surface can ensure proper and easy handling of medical devices for effective drug delivery and error-free performance.

Today, thermoplastic elastomers (TPEs) are widely used for a soft-touch surface and feel. Moreover, the varied mechanical properties of TPEs in medical device applications, such as ease of coloration, flexibility and purity, contribute to the aesthetic appearance and high usability of the products.

For manufacturers, TPEs are the perfect choice of materials, owing to their easy processing, for example, via injection molding or extrusion process.

KRAIBURG TPE, a global TPE manufacturer of a wide range of thermoplastic elastomer products and custom solutions for multiple industries, offers high quality and custom-engineered THERMOLAST® M compounds that conform to the soft-touch requirements of medical device applications.

Taking a safe approach

For soft-touch surfaces in medical device applications, KRAIBURG TPE offers the THERMOLAST® M MC/AD/PA series of compounds that are sterilizable by using methods such as EtO gas, γ-gamma ray treatment (2 x 35 kGy) and β-ray (electron beam) treatment (2 x 35 kGy). The THERMOLAST® M series is also free of latex, PVC and phthalates, allowing it to be used for medical devices.

The THERMOLAST® M has been specially formulated for applications requiring medical approvals and conforms to standards such as ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Intracutaneous irritation).

The MC/AD/PA compounds have excellent adhesion to various polyamides such as PA6 and PA12, allowing for use in applications requiring soft-touch grips, sealing, flexible connectors, switches, and mats in the medical devices industry. The compounds can also be applied in handles, buttons and closures that require soft-touch surfaces for medical devices.

The compounds can be colored in various options using Pantone and RAL as a color reference, allowing for differentiation of end products.

Approved to exacting standards

KRAIBURG TPE’s THERMOLAST® M MC/tl series is certified to standards such as ISO 10993-10 (Intracutaneous injection), ISO 10993-5 (Cytotoxicity), ISO 10993-4 (Hemolysis), ISO 10993-11 (Acute systemic toxicity) and VDI 2017.

It comes in natural colors and can be colored in many ways. It has excellent adhesion to PP and PE, allowing it to be applied on mouthpieces and as a soft-touch element on medical devices.

The MC/tl series has optimized compression set and has excellent abrasion resistance, for applications that require high contact and friction such as handles and grips on medical devices and sealings on respiratory masks.

Medical Service Package

KRAIBURG TPE strives to maintain the standards of its products by providing a unique service package that focuses on customer needs. It does this by constantly recording the manufacturing process in the drug Masterfile (DMF); and by guaranteeing 24-month supply security and purity of raw materials through the commitment of suppliers.

It also has a dedicated production unit for the manufacture of THERMOLAST® M to ensure quality, safety and reliability of the compounds.