YY/T 0681.16-2019 Active Industry standards-Medicine

YY/T 0681.16-2019 Test methods for sterile medical device package—Part 16:Test for climatic stressing of packaging system

Publish Date: 2019-05-31 Implement Date: 2020-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0681.16-2019

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Generally, it refers to microsurgical instruments

ICS Name: Medical equipment

Publish Date: 2019-05-31

Implement Date: 2020-06-01

Pages: 6 pages

Scope

This part of YY/T 0681 specifies a unified benchmark for evaluating the ability of aseptic medical device packaging systems to protect products from damage or changes during the circulation cycle under possible climatic stresses.
This part is applicable to an independent test evaluating the climatic resistance of packaging systems; it is also applicable to the conditioning method before testing a single packaging system that has undergone overnight or two-day supply requirements.
This part is not applicable to the climatic resistance test of packaging systems for refrigerated, frozen, or low-temperature storage and transportation.