出版物: 2019 年 10 月 16 日最近更新時間: 2025 年 3 月 10 日

这种经过全面认证的可灭菌化合物具有 PA 兼容性

凯柏胶宝®推出全球首款符合 VDI 2017 要求的热塑宝 M 复合材料，适用于 TPE/PA 组合应用

凯柏胶宝®推出全新 MC/AD/PA 热塑宝 M 系列，这也是世界上首批符合欧盟和 FDA 标准、可应用于医疗领域的热塑性弹性体产品，可直接与聚酰胺结合使用。

随着有关医用级塑料（MGP）的国际法规日益严格，医疗器械和保健产品制造商为提高竞争优势，迫切需要既符合相关法规又美观可靠的材料解决方案。多组分应用制造领域就是一个典型的例子，该行业通过使用直接注塑成型（不使用粘合剂）将“硬质”聚合物与“软质”热塑性弹性体（TPE）组合在一起，有效节省安装时间。目前市场上符合 MGP 标准的 TPE 化合物无法粘合聚酰胺（PA），因此不适合许多复杂的应用领域。

凯柏胶宝®的全新 MC/AD/PA 热塑宝 M 系列填补了这一空白。凯柏胶宝®医疗应用业务部经理 Oliver Kluge 表示：“这是首款适用于医疗应用领域的可与聚酰胺粘合成复合材料的 TPE。我们期待在 K 2019 展会期间向业界推出这个系列的产品，包括透明的 PA12。”这些化合物已进行全面认证，可制造不同类型的医疗设备，包括用于体外诊断的设备。

新 TPE 系列的化合物符合最近刚刚颁布的 VDI 2017 指南。该指南从基本要求、配方一致性和改性管理等方面全面规范了 MGP 兼容材料的标准。它们也符合欧盟法规（EU）第 10/2011 号和美国食品药品管理局（FDA）联邦法规第 21 条（21CFR）的规定。

根据 ISO 10993-5 和 10993-11 标准的规范，新 TPE 还符合在人类兼容性方面的要求。这种材料还可以通过使用 β 或 γ 射线或环氧乙烷（EtO），消灭所有类型的细菌。它们还符合关于限制某些有害物质使用的 2011/65/EU（RoHS）指令，以及相关化学品注册、评估、授权和限制（REACH）的（EC）1907/2006 号法规。

和所有热塑宝 M 产品一样，MC/AD/PA 化合物不含乳胶、PVC 和邻苯二甲酸盐，生产过程中不使用重金属。凯柏胶宝®仅在经过特殊批准的生产线上专门生产这种新开发的材料。为实现全方位的质量保证，所有产品还提供供应商原材料的完全可追溯性。目前提供的硬度范围在邵氏硬度 A 60 到 70 之间。这种材料的表面光滑而柔软，触感十分舒适，但兼具极佳的抗剐蹭、磨损和皮脂（分泌到皮肤表面的油脂）能力。

凯柏胶宝®将在 K 2019 展会的 6 号展厅 C58-4 展位展示全新 MC/AD/PA 热塑宝 M 系列。

全球首个获得 MGP 认证的 TPE 系列产品，其聚酰胺粘合力非常适用于制作医疗设备。

（图片来源：© 2019 凯柏胶宝®版权所有）

Fully certified and sterilizable compounds compatible with PA

KRAIBURG TPE to introduce the world’s first VDI 2017-compliant THERMOLAST® M compounds for TPE/PA composite applications

With its new MC/AD/PA THERMOLAST® M series, KRAIBURG TPE launches the first thermoplastic elastomers that not only hold certifications for healthcare applications in accordance with EU and FDA standards but can also be combined directly with polyamides.

As international regulations for medical-grade plastics (MGPs) have become more and more strict, manufacturers of products for medical devices and healthcare are increasingly looking for opportunities to strengthen their competitive edge by solutions that both comply with the regulations and are aesthetically pleasing. A representative example is the manufacture of multicomponent applications that saves mounting time by combining a “hard” polymer with a “soft-touch” thermoplastic elastomer (TPE) using direct injection molding (without bonding agents). The MGP-compliant TPE compounds that have been available in the market so far do not provide adhesion to polyamides (PA) and thus cannot be used for many sophisticated applications.

KRAIBURG TPE’s new MC/AD/PA THERMOLAST® M series closes this gap. “We are looking forward to introducing the world’s first TPEs for medical applications in composites with polyamides – including transparent PA12 – to the industry at K 2019,” says Oliver Kluge, Business Unit Manager Medical Applications at KRAIBURG TPE. “The compounds are fully certified and suitable for a variety of attractive medical devices, including those used for in vitro diagnostics.

The compounds of the new TPE series meet the recently adopted VDI 2017 guideline that regulates the criteria for MGP-compliant materials – from basic requirements to formulation consistency and modification management. They comply with the Commission Regulation (EU) No. 10/2011 and the Code of Federal Regulations Title 21 (21CFR) of the U.S. Food and Drug Administration (FDA).

The new TPEs also meet the requirements for human compatibility in accordance with the specifications of the ISO 10993-5 and 10993-11 standards. All types can be sterilized using beta or gamma radiation, or ethylene oxide (EtO). They also comply with Directive 2011/65/EU on the restriction of the use of certain hazardous substances (RoHS) as well as Regulation (EC) No. 1907/2006 concerning the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH).

Like all THERMOLAST® M products, the MC/AD/PA compounds are free of latex, PVC, and phthalates, and they are produced without the use of heavy metals. KRAIBURG TPE manufactures the newly developed materials exclusively on specially approved production lines. Quality assurance extends through to full traceability of raw materials on the suppliers’ side. Types with a hardness range between 60 and 70 Shore A are currently available. They provide smooth and velvety surfaces with a pleasantly soft touch featuring excellent resistance to scratches, wear, and sebum (lipids secreted to the skin’s surface).

KRAIBURG TPE will present its new MC/AD/PA THERMOLAST® M series during K 2019 in hall 6 at booth C58-4.