ISO 10993

What is ISO 10993?

The ISO 10993 – Biological Evaluation of Medical Devices – is a series of internationally recognized regulatory standard by the British Standard Institution (BSI). ISO 10993 entails 22 parts which provide comprehensive regulatory requirements to evaluate and control the biocompatibility of medical devices. According to BSI, biocompatibility is the “ability of a material to perform with an appropriate host response in a specific application”. Therefore, obtaining this ISO certification will provide trust and concrete validation that our product are indeed reliable for use.

Why is ISO 10993 important for our 3D printed filament and implants?

Our bioactive filament and 3D printed products will ultimately be implanted into the body for clinical use. Hence, it encompasses high-risks and is considered as a class III medical device. One of the components for OSSFILA to be approved for commercial use is to ensure that the implants is biocompatible and constitute no long-term biological risks. To fulfil the ISO 10993 requirements, it involves stringent test which can confidently prove that OSSFILA implants and filaments can integrate with the host without any long-term biological risks. OSSFILA is currently in preparation to be equip for the stringent test in order to initiate our ISO 10993 application.

ISO 10993 是什么?

ISO 10993 ╴医疗器材生物相容性试验,是英国标准学会(BSI)提供的国际标准。它拥有22部份,提供全面的执行生物相容性的试验,以评估及控制医疗器材的生物相容性。根据BSI,生物相容性的定义为「在特定应用下,物料能在宿主环境下作出适当反应的能力」,因此获得此ISO认证,实质地验证产品的使用可靠程序,提高客户的信赖。

 

ISO 10993 对我们产品的重要性

我们的生物活性线材和3D打印技术最终会用于医学移植,所以产品为第三级的高风险医疗用途器材。 OSSFILA 为得到商业用的认可,其中一环是确保植入物的生物相容性和不构成长期生理风险。要达到 ISO 10993 的要求,OSSFILA 的产品会通过一系列的严格测试,以证明它们能与宿主的骨骼结合并排除长期生理风险。 OSSFILA 现严正地装备以应付严格测试,并开始申请 ISO 10993 的认证。

ISO 10993 是什麼?

ISO 10993 ╴醫療器材生物相容性試驗,是英國標準學會(BSI)提供的國際標準。它擁有22部份,提供全面的執行生物相容性的試驗,以評估及控制醫療器材的生物相容性。根據BSI,生物相容性的定義為「在特定應用下,物料能在宿主環境下作出適當反應的能力」,因此獲得此ISO認證,實質地驗證產品的使用可靠程序,提高客戶的信賴。

 

ISO 10993對我們產品的重要性

我們的生物活性線材和3D打印技術最終會用於醫學移植,所以產品為第三級的高風險醫療用途器材。 OSSFILA 為得到商業用的認可,其中一環是確保植入物的生物相容性和不構成長期生理風險。要達到 ISO 10993 的要求,OSSFILA 的產品會通過一系列的嚴格測試,以證明它們能與宿主的骨骼結合並排除長期生理風險。 OSSFILA 現嚴正地裝備以應付嚴格測試,並開始申請 ISO 10993 的認證。