YY/T 0698.5-2023: Packaging materials for terminal sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods

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Scope

This document specifies requirements and test methods for sealable pouches and reels
of porous materials compliant with YY/T 0698.2, 0698.3, 0698.6, 0698.7, 0698.9, or
0698.10, and plastic film construction with Clause 4 of this document. These sealable
pouches and reels are intended to be used as sterile barrier systems and/or packaging
systems to maintain the sterility of finally sterilized medical devices until the point of
use.
In addition to the general requirements specified in GB/T 19633.1 and GB/T 19633.2,
this document specifies the specific requirements and test methods for the materials
covered by this Part.
This document applies solely to packaging materials for single-use, terminally sterilized
medical devices.

Basic Data

Standard ID	YY/T 0698.5-2023 (YY/T0698.5-2023)
Description (Translated English)	Packaging materials for terminal sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C31
Classification of International Standard	11.080.040
Word Count Estimation	20,222
Date of Issue	2023-09-05
Date of Implementation	2024-09-15
Older Standard (superseded by this standard)	YY/T 0698.5-2009
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the requirements and test methods for sealable combination bags and rolls composed of breathable materials that comply with YY/T 0698.2, 0698.3, 0698.6, 0698.7, 0698.9 or 0698.10 and plastic films that comply with Clause 4 of this document. These sealable combination bags and rolls can be used as sterile barrier systems and/or packaging systems to maintain the sterility of terminally sterilized medical devices until use. In addition to the general requirements specified in GB/T 19633.1 and GB/T 19633.2, this standard specifies specific requirements and test methods for the materials covered by this part. This document applies only to packaging materials for single-use terminally sterilized medical devices.