YY/T 1772-2021 Active Industry standards-Medicine

YY/T 1772-2021 Implants for surgery—Standard test method for conducting and evaluating galvanic corrosion tests in electrolytes

Publish Date: 2021-03-09 Implement Date: 2022-04-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1772-2021

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2021-03-09

Implement Date: 2022-04-01

Pages: 16 pages

Scope

This standard provides methods for the electrochemical corrosion testing and evaluation of surgical implants, covering sample selection, sample preparation, testing environment, exposure methods, and evaluation methods for testing results of the corrosion behavior of electrochemical couples in electrolyte solutions.
This standard is applicable to characterizing the corrosion behavior of two or more different metals in an electrical contact state when used as surgical implants or their components in the human body.
This standard is not applicable to evaluating other forms of corrosion and degradation affecting surgical implants. It is also not applicable to evaluating changes in surface conditions.
Note 1: Possible types of devices that may need to be evaluated include overlapping stents of different alloys, combinations of stents and stent markers, combinations of bone plates and screws where one or more screws belong to different alloys from the rest of the device, and multi-component structures made of two or more alloys. This standard can also be used to evaluate devices that are partially implanted but in long-term contact with the human body (such as external fixation devices).
Note 2: Other forms of corrosion and degradation affecting devices include, but are not limited to, the following: such as micro-motion corrosion, crevice corrosion, and the effects of any electrochemical corrosion on stress corrosion and corrosion fatigue.
Note 3: Changes in surface conditions include, but are not limited to, the following: such as scratches that may occur during the implantation process or welding effects during the manufacturing process.