YY/T 0681.17-2019 Active Industry standards-Medicine

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

Publish Date: 2019-10-23 Implement Date: 2020-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0681.17-2019

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Generally, it refers to microsurgical instruments

ICS Name: Packaging materials and auxiliary items

Publish Date: 2019-10-23

Implement Date: 2020-10-01

Pages: 12 pages

Scope

This part of YY/T 0681 specifies the aerosol filtration performance of breathable packaging materials by generating aerosols with a diameter of 1.0 μm, and evaluates the filtration efficiency of the materials using two particle counters.
This part of YY/T 0681 is applicable to breathable materials used for the packaging of final sterilized medical devices.
This part of YY/T 0681 is not applicable to materials with a breathability rate1) exceeding 4,000 mL/min.