This Part of YY/T 0681 specifies the test method for the non-destructive detection of the leakage of the packaging system of sterile medical devices, by the vacuum decay method. This Part applies to rigid and semi-rigid trays without lids, trays or cups with porous barrier covers, nonporous rigid packaging, nonporous flexible packaging.
Basic Data
Standard ID
YY/T 0681.18-2020 (YY/T0681.18-2020)
Description (Translated English)
Test methods for sterile medical device package - Part 18: Nondestructive detection of leaks in packages by vacuum decay method
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
X31
Classification of International Standard
11.080.40
Word Count Estimation
22,234
Date of Issue
2020
Date of Implementation
2021-04-01
Issuing agency(ies)
State Drug Administration
Summary
This standard specifies a test method for non-destructive testing of leaks in sterile medical device packaging systems using the vacuum decay method. This standard applies to rigid and semi-rigid uncovered trays, trays or cups with breathable barrier covers, non-breathable rigid packaging, and non-breathable flexible packaging.
