YY/T 0509-2009 (English Version) PDF

Scope: This standard specifies the relevant mechanical properties and test methods for orthopedic internal fixation plates and screws made of hydrolyzable polymer resin. This standard specifies commonly used terms for dimensions and other physical properties of absorbable external implants and also defines performance terms related to absorbable medical devices. This standard specifies some standard test methods that can continuously test the mechanical properties of absorbable implants under specified conditions such as pretreatment, temperature, humidity and test device speed. Not all absorbable medical devices are applicable to this standard. Users should consider the applicability of this standard based on the specific absorbable medical device and its possible areas of application. This standard does not attempt to address all safety issues covered, even those relevant to its use. It is the responsibility of the user of this standard to establish appropriate safe operating practices and to clarify the applicability of regulatory limitations prior to application.

YY/T 0509-2009 history

2009 YY/T 0509-2009 Standard specification and test methods for bioabsorbable plates and screws for internal fixation implants