YY/T 1427-2016 Active Industry standards-Medicine

YY/T 1427-2016 Implants for surgery—Test solutions and environmental condition for static and dynamic corrosion tests on implantable materials and medical devices

Publish Date: 2016-01-26 Implement Date: 2017-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1427-2016

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2016-01-26

Implement Date: 2017-01-01

Pages: 13 pages

Scope

This standard specifies the standard environmental conditions for testing metal materials used in implants, surgical implants, and medical devices. These test conditions simulate physiological conditions by controlling the test solution, temperature, ventilation environment, and the ratio of sample size to solution volume in a simplified manner.
When necessary, the application of these environmental test conditions can be combined with various static or dynamic tests influenced by physiological environments. Typical applications include corrosion fatigue tests, micro-motion and wear tests, and routine electrochemical tests.
This standard does not consider typical joint simulator tests and specific applications in the dental field. Solutions that attempt to reproduce the tribological performance of body fluids, such as those used in wear studies, are not within the scope of this standard.