過去10年間、医療機器と生体材料の産業界は、大変多くの技術革新および変化を経験してきました。材料と技術は進化し、数グラムの重さのステントがインプラントとして、外科手術により患者の神経血管に挿入されるようになっているとともに、発送時のパッケージングの技術革新は薬の配達のプロセスをより単純化するのに役立っています。

これに対応して、全ての製品における安全性と効率性を確保するために、規制の関与が大幅に拡大してきました。このような状況の変化に伴い、各デバイスの設計概念から最終製品まで全面的な評価が要求されるようになっています。物理試験および有限要素解析(FEA)は、世界中の医療機器メーカーの研究分野において一般的になっています。総合的なソリューションを提供するインストロンは、医療機器と生体材料を試験できる専用または標準システムの設計および製作しています。
 






KEY CONSIDERATIONS
When Selecting a Testing System for Biomedical Applications

Biomedical Testing Systems


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Reliability

The average life of an Instron system is over two decades, ensuring our customers can be confident in their investment.


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Repeatability

Instron designs, manufactures, calibrates, and verifies our own sensors from force transducers to extensometers, ensuring optimal system performance.


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Ease of Use

Instron customers trust that any new system is intuitive and easy to use for an operator of all skill levels for any application.


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FDA Compliance

Instron offers validation assistance to meet FDA guidelines such as IQ, OQ, and PQ, and offers software that enables users to meet requirements of FDA 21 CFR Part 11.


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Application Expertise

With dozens of members on standards committees such as ASTM and ISO, Instron stays at the forefront of application expertise.


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Footprint

Bluehill Universal equipped with the Operator Dashboard allows for a small physical footprint on an Instron system. This small footprint allows labs to save space, stay organized, and keep clean.


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Materials used in the pharmaceutical industry that require mechanical testing are typically drug delivery systems, tablets, packaging, injectors, luer locks, and syringes. This broad category of materials are most commonly thought of as a means to deliver a drug to a patient. The delivery could be via a shot in a patient’s leg, an intravenous line placed in a patient’s arm, or simply by allowing that patient to open up a medicine bottle. Regardless of the delivery method, it is critical for companies to test the materials and components used in pharmaceutical products to help ensure proper dose, delivery times, patient usability, and safety.

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外科用製品


Surgical products are also known as medical consumables and are the products that are often single-use items found in doctor’s offices and hospitals. These products are often made from plastic materials and include medical tubing, catheters, hospital gowns, gloves, and sutures. These products can range from Class I to Class II medical devices and require a variety of different static mechanical testing.

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整形外科用製品


Orthopedic implants are considered to be specialized implantable devices. Orthopedic implants are implants that support the skeletal system and include bone screws, plates, rods and pins for fracture repair, as well as entire artificial hips, knees, and spinal components. Orthopedic implants can be inserted in the body to assists a patient’s healing and be temporary, or can be inserted in the body with the intent that the implant will outlive the patient. Depending on the use, orthopedic implants are typically considered to be Class II or Class III medical devices by the FDA and require a range and combination of static and fatigue mechanical testing.

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インプラントデバイス


Non-orthopedic implantable devices are considered to be permanent implantable devices that do no support the skeletal system. Commonly, implantable devices include medical devices that support the circulatory system and cardiovascular system. For example, stents, heart valves, and pacemakers fall into this category. Implantable medical device are often considered to be classified as Class III medical devices by the FDA, and must undergo stringent mechanical testing through a combination of both static and fatigue testing, before being released to the market.

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バイオマテリアル


Biomaterials are the materials found in nature, the human body, and other animal species. These materials can be hard tissues like bone or dental enamel, or soft like tendons and ligaments. As one may expect, biological variation and environmental factors affect the mechanical properties of these materials. These materials are anisotropic and nonhomogeneous making them challenging materials to re-create or engineer outside of nature.

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歯科材料


Dental materials are typically composed of metal, elastomers, and polymers. Restorative and prosthodontic devices are often composed of multiple materials that require mechanical testing to determine how these materials interact to form the entire device. A dental implant is a metal, typically titanium, post that replaces the patient’s entire root and tooth. And artificial tooth, known as a crown, is placed on the dental implant post. Fatigue testing dental implants is the most common mechanical tests in the dental segment.

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RECOMMENDED TESTING SYSTEMS
For Biomedical Applications

Single Column Universal Testing Machine



Low Force
Universal Testing System

Commonly used to perform tensile, compression, peel, and bend tests on medical devices, packaging, pharmaceuticals, and biomaterials.
 

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5965 Tabletop Universal Testing System



Mid-Range
Universal Testing System

Commonly used to perform tensile, compression, and bend testing on larger or higher capacity medical devices.
 

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Torsion Add-On for Axial and Torsion Testing



Torsion Add-On
for Biaxial Testing

Commonly used to reduce product development time and simulate real-world applications of products such as Luer Locks and bone screws.
 

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Auto-Injector Testing System



Auto-Injector
Testing System

Our integrated auto-injector test system performs a variety of tests to ISO 11608-5 and allows for all required testing to be carried out in a single test for individual auto-injectors.
 

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Curved Needle Tester



Curved Needle
Testing System

The curved needle puncture testing fixture is used to evaluate needle sharpness and insertion force; the needle bend testing fixture is used to evaluate flexural properties of the needle during use.
 

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ElectroPuls E1000 Dynamic and Fatigue Testing System



All-Electric Dynamic and Fatigue Testing System

All-electric table top test instruments designed for dynamic and static testing on a wide range of materials and components.
 
 

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