Establishment of Sampling Inspection Scheme Paradigm for Medical Device Sampling Inspection.
10.3969/j.issn.1671-7104.2019.04.014
- Author:
Qing HAO
1
;
Xintao ZHANG
1
;
Jiong ZHU
1
Author Information
1. National Institutes for Food and Drug Control, Beijing, 102629.
- Publication Type:Journal Article
- Keywords:
medical device;
paradigm;
sampling;
testing
- MeSH:
Equipment Safety;
methods;
Guidelines as Topic
- From:Chinese Journal of Medical Instrumentation
2019;43(4):286-289
- CountryChina
- Language:Chinese
-
Abstract:
This paper introduces the sampling scheme and the inspection scheme paradigm followed in organizing the sampling inspection of medical devices. The sampling scheme paradigm includes the definition and operation guidelines for sampling products, the regulations for individual sampling batches and related model specifications, accessory data, validity period, storage conditions, etc., the requirements for sampling areas, places and quantities, and the requirements for samples to be sent to inspection institutions. The inspection scheme paradigm includes the provisions for inspection basis, inspection items and determination principles.
