YY/T 0681.17-2019: Test methods for sterile medical device package - Part 17: Testing the microbial barrier performance of porous package materials using aerosol filtration method
This Part of YY/T 0681 specifies the determination of the aerosol filtration performance using aerosol that generates particles with a diameter of 1.0 m, and the evaluation of the filtration efficiency of the material using two particle counters. This Part of YY/T 0681 is applicable to air permeable materials used for the packaging of terminally sterilized medical devices. This Part of YY/T 0681 does not apply to materials with Bendtsen air permeability1) over 4,000 mL/min.
Basic Data
Standard ID
YY/T 0681.17-2019 (YY/T0681.17-2019)
Description (Translated English)
Test methods for sterile medical device package - Part 17: Testing the microbial barrier performance of porous package materials using aerosol filtration method
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C31
Classification of International Standard
11.080.40
Word Count Estimation
12,167
Date of Issue
2019
Date of Implementation
2020-10-01
Issuing agency(ies)
State Drug Administration
Summary
This standard specifies the determination of the aerosol filtration performance of breathable packaging materials by generating aerosols of particles with a diameter of 1.0 ��m, and the use of two particle counters to evaluate the filtration efficiency of the material. This standard applies to breathable materials for terminally sterilized medical device packaging. This standard does not apply to materials with a Bentsen air permeability exceeding 4000 mL/min.
