English Abstract

Performance and Safety Requirements for Medical Rubber Components

TERUMO Corporation, Quality Assurance Department, Ashigarakami-gun, Kanagawa, Japan
Nippon Gomu Kyokaishi,(2014),87(10),416-421 General Review in Japanese

The medical rubber components are widely used in the medical field with advantage of its sealability, flexibility, and elasticity. In recent years, usage of thermoplastic elastomers with high workability and equal performances to rubbers is growing. For example, latest urinary balloon catheters are fully made of thermoplastic elastomers.
On the other hand, risk management and minimization is essential to secure safety of medical devices. Biological evaluation should be carried out in accordance with Annex A of ISO 10993-1:2009i JIS T0993-1 F2012jto proof a safety of a medical device. Natural rubber latex is not recommended for implantable devices because of its allergenic nature.

Keywords: Medical Device, Rubber and Thermoplastic Elastomer, Biocompatibility, Natural Rubber Allergen