This Part of YY/T 0681 specifies a uniform method for evaluating the ability of sterile medical device shipping units to withstand the transport environment in the laboratory. This Part is used for guiding the user to design an appropriate test plan, so that the shipping unit can withstand a series of expected hazards to be experienced in a specific distribution cycle. This Part does not include performance testing of single parcel transport packages.
Basic Data
Standard ID
YY/T 0681.15-2019 (YY/T0681.15-2019)
Description (Translated English)
Test methods for sterile medical device package - Part 15: Performance testing of shipping containers and systems
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C31
Classification of International Standard
11.080.40
Word Count Estimation
23,231
Date of Issue
2019
Date of Implementation
2020-10-01
Issuing agency(ies)
State Drug Administration
Summary
This standard specifies a uniform method for evaluating the ability of sterile medical device transport units to withstand the transport environment within the laboratory. This International Standard is intended to guide the user in designing an appropriate test protocol for subjecting the transport unit to a range of expected hazards (sources) to be experienced during a particular circulation cycle. This standard does not cover performance testing of single-package transport packaging.
