This Standard provides a guide for design and evaluation of primary flexible packaging for medical devices. This Standard does not involve acceptability criteria. NOTE: the acceptability criteria are jointly determined by the packaging manufacturer and the medical device manufacturer. This Standard is applicable to the design and evaluation of primary flexible packaging of medical devices aseptically and non-aseptically provided.
Basic Data
Standard ID
YY/T 1759-2020 (YY/T1759-2020)
Description (Translated English)
Guide for Design and Evaluation of Primary Flexible Packaging for Medical Devices
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C30
Classification of International Standard
11.040.01
Word Count Estimation
25,251
Date of Issue
2020-09-27
Date of Implementation
2021-09-01
Regulation (derived from)
Announcement No. 108 (2020) of the National Medical Products Administration
