Sampling Procedures for Inspection by Attributes and Application on Field of Medical Devices.
10.3969/j.issn.1671-7104.2022.05.013
- Author:
Bo ZHANG
1
;
Min WAN
1
;
Xiang ZHANG
1
;
Wei XIONG
1
;
Wenli LI
1
;
Cong CHEN
1
Author Information
1. Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection, Jinan,
- Publication Type:Journal Article
- Keywords:
acceptance quality limit;
declared quality level;
limiting quality;
sampling inspection;
supervision and inspection
- MeSH:
Commerce;
Quality Control;
Reference Standards
- From:
Chinese Journal of Medical Instrumentation
2022;46(5):538-544
- CountryChina
- Language:Chinese
-
Abstract:
Sampling inspection by attributes is one of the most popular means for quality control of medical devices, and has widespread application in the process of production and supervision. GB/T 2828 series standards list different types of sampling procedures for inspection by attributes. This study introduced GB/T 2828 series standards and how to design and index the sampling schemes under different scenarios. At the same time, it also provided suggestions on how to balance accuracy and economy, which can provide guidance the application of medical devices manufactures and regulatory departments.
