English Abstract

Rubber Components for Medical Devices

Kokoku Intech Co., Ltd., Kita-adachi-gun, Saitama, Japan
Nippon Gomu Kyokaishi,(2021),94(6),187-191 General Review in Japanese

In this review, rubber components for medical devices, especially disposable (single-use) devices, are explained. Synthetic rubbers have been developed since World War II. They are used even in various medical devices. However, its scope of application is limited, most synthetic rubber components are used only for applications that do not come into direct contact with biological tissue, or even come into contact with, only skin and mucous membranes.
Disposable medical devices have been also developed rapidly since the 1950s, and adopted a large number of synthetic rubber components that take advantage of their flexibility, elasticity, and resealability after removing the pierced needle. Chemical and biological evaluation should be carried out to prove the safety of medical devices, recently, the demand for E & L (extractable and reachable) testing at the component level is increasing.

Keywords: Medical Device, Precision Rubber Components, Disposable Syringe Gasket, Resealability, E&L Testing, Infusion System, Vacuum Blood Collection System, Pre-filled Syringe.