YY/T 0698.2-2009: Packaging materials for terminal sterilized medical devices. Part 2: Sterilization wrap. Requirements and test methods

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Scope

This Part of YY/T 0698 provides test methods and values for materials for
preformed sterile barrier systems and packaging systems that are intended to
maintain sterility of terminally sterilized medical devices to the point of use.
This Part introduces no additional requirements to the general requirements
specified in ISO 11607-1.As such, the particular requirements in 4.2 can be
used to demonstrate compliance with one or more but not all of the
requirements of ISO 11607-1.
NOTE 1.If the intended use as specified by the manufacturer includes the possibility of
the material being used as a sterile field or a surgical drape the YY/T 0506 series applies.
NOTE 2.If the intended use as specified by the manufacturer includes the possibility of
the material being used as container filter or as an inner wrap for containers then additional
and/or other requirements can apply, see e. g. YY/T 0698.8.

Basic Data

Standard ID	YY/T 0698.2-2009 (YY/T0698.2-2009)
Description (Translated English)	Packaging materials for terminal sterilized medical devices. Part 2: Sterilization wrap. 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	15,144
Date of Issue	2009-06-16
Date of Implementation	2010-12-01
Quoted Standard	GB/T 451.2; GB/T 454; GB/T 455; GB/T 458; GB/T 465.1; GB/T 465.2; GB/T 1540; GB/T 1545.2; GB/T 2678.6; GB/T 3917.1-1997; GB/T 4744; GB/T 4745-1997; GB/T 5453-1997; GB/T 7408; GB/T 7742.1; GB/T 7974-2002; GB/T 12914; ISO 6588-2-2005; ISO 9073-3; ISO 9073-9; ISO 9197; ISO 11607-1; EN 1149-1-2006
Regulation (derived from)	Industry standard filing Notice 2009 No. 9
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the expected before use to keep terminally sterilized medical devices preformed sterile barrier systems and packaging systems for material requirements and test methods. This part is not general requirements for ISO 11607-1 requirements increase, so that 4. 2 requirements for ISO 11607-1 can be used to demonstrate compliance with one or more of the requirements, but not all of its requirements.