This document specifies requirements and test methods for materials of preformed barrier systems and packaging systems that are intended to maintain the sterility of terminally sterilized medical devices until use. This document is applicable to the determination of the properties of flat paper wrapping materials, crepe paper wrapping materials, and nonwoven wrapping materials intended for single use, as well as textile wrapping materials intended for repeated use.
Basic Data
Standard ID
YY/T 0698.2-2022 (YY/T0698.2-2022)
Description (Translated English)
Packaging materials for final sterilized medical devices - Part 2: Requirements and test methods for sterilized packaging materials
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C31
Word Count Estimation
15,181
Date of Issue
2022-10-17
Date of Implementation
2023-10-01
Older Standard (superseded by this standard)
YY/T 0698.2-2009
Issuing agency(ies)
State Drug Administration
Summary
This International Standard specifies requirements and test methods for materials of preformed barrier systems and packaging systems intended to maintain the sterility of terminally sterilized medical devices until use. This standard applies to the determination of the properties of plain paper wrapping materials, crepe paper wrapping materials, non-woven fabric wrapping materials and textile wrapping materials intended for repeated use intended for single use.
