Discussion on Influencing Factors of Validation of Cleaning Process in Manufacture of Implantable Medical Devices.
10.12455/j.issn.1671-7104.250128
- Author:
Xin LIU
1
;
Xiaofei MA
1
Author Information
1. Center for Medical Device and Cosmetics Evaluation and Verification, Shanghai,
- Publication Type:Journal Article
- Keywords:
cleaning process;
implantable medical devices;
manufacture;
validation
- MeSH:
Prostheses and Implants;
Sterilization;
Equipment and Supplies
- From:
Chinese Journal of Medical Instrumentation
2025;49(5):572-578
- CountryChina
- Language:Chinese
-
Abstract:
Cleaning process validation is an important guarantee for implantable medical devices to ensure product cleanliness. In the manufacturing process, implantable devices usually need to control pollution through cleaning process to achieve a certain cleanliness to ensure the effectiveness of sterilization and product safety. This paper discusses the cleaning process validation of the manufacturing process of the implantable devices based on relevant regulations and technical standards, and proposes the influencing factors and principles to be considered in the cleaning process validation, so as to provide technical reference for the design of the cleaning process validation.
