YY/T 0681.1-2018: Test methods for sterile medical device package - Part 1: Test guide for accelerated aging

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Scope

This Part of YY/T 0681 specifies the guide for designed accelerated aging
solutions.
This Part applies to the rapid determination of the sterile integrity of the sterile
barrier system specified in GB/T 19633.1-2015 and the effects that physical
properties of its packaging material components are affected by the elapsed
time.
NOTE 1.Use the information in this Part of YY/T 0681 to support the expiration date of the medical device
sterile barrier system (i.e. shelf life).
This Part is not applicable to real-time aging solution.
NOTE 2.Accelerated aging test involves sterile barrier system with or without instruments. This Part does
not address the compatibility of sterile barrier system materials with instrument interactions required during
new product development or evaluation.
NOTE 3.Real-time aging test is a basic aging study used to determine the results of accelerated aging
tests.
NOTE 4.This Part does not address methods for confirmation of sterile barrier system, including effects
on mechanical processing, sterilization processes, circulation, handling and transport. The ability of the
sterile barrier system to resist transport challenges is given in YY/T 0681.15.
NOTE 5.This Part does not address the effects of extreme weather conditions that may be experienced
in a simulated transport environment. For the climatic strain capacity test of the sterile barrier system, see
YY/T 0681.16.

Basic Data

Standard ID	YY/T 0681.1-2018 (YY/T0681.1-2018)
Description (Translated English)	Test methods for sterile medical device package - Part 1: Test guide for accelerated aging
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C31
Classification of International Standard	11.080.040
Word Count Estimation	16,181
Date of Issue	2018-12-20
Date of Implementation	2020-01-01
Older Standard (superseded by this standard)	YY/T 0681.1-2009
Regulation (derived from)	State Drug Administration Announcement No.97 of 2018
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies guidelines for designing accelerated aging solutions. This standard applies to the rapid determination of the aseptic integrity of the sterile barrier system specified in GB/T 19633.1-2015 and the physical characteristics of its packaging material components are affected by the elapsed time. This standard does not apply to real-time aging solutions.