YY/T 0698.5-2009: Packaging materials for terminal sterilized medical devices. Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction. Requirements and test methods

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Scope

This Part of YY/T 0698 provides requirements and test methods for sealable pouches
complying with the Part 3, Part 6, Part 7, Part 9 and Part 10 in YY/T 0698 and reels
manufactured from porous materials specified in 4.2.2 of this Part.
This Part adds no additional requirements to the general requirements specified in ISO
11608-1.As such, the particular requirements in 4.2~4.5 can be used to verify
compliance with one or more but not all of the requirements specified in ISO 11607-1.
Sealable pouches and reels specified in this Part apply to the packaging of medical
devices which are to be terminally sterilized.
The use of sealable pouches and reels as preformed sterile barrier systems enables
ease of presentation; most importantly, the users are able to see the contents of the
pack before it is opened.

Basic Data

Standard ID	YY/T 0698.5-2009 (YY/T0698.5-2009)
Description (Translated English)	Packaging materials for terminal sterilized medical devices. Part 5: Heat and self-sealable pouches and reels of paper 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	11,197
Date of Issue	2009-06-16
Date of Implementation	2010-12-01
Quoted Standard	GB/T 7408; GB 18282.1; YY/T 0698.3; YY/T 0698.6; YY/T 0698.7; YY/T 0698.9; YY/T 1698.10; ISO 11607-1; ASTM D 882-1995
Adopted Standard	prEN 868-5-2007, IDT
Regulation (derived from)	Industry standard filing Notice 2009 No. 9
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the use comply with YY/T 0698 Part 3, Part 6, Part 7, Section 9 or Section 10 breathable material and meet the provisions of this section 4. 2. 2 sealable plastic film composed of combinations of bags and roll material requirements and test methods. This part is not general requirements for ISO 11607-1 requirements increase, so that 4. 2 to 4. 5 in the special requirements of ISO 11607-1 can be used to demonstrate compliance with one or more of the requirements, but not all of its requirements. This standard specifies a sealable bag and a roll for a combination terminally sterilized medical device packaging. Combined bag and the membrane can be sealed as preformed sterile barrier systems, it is important that the user can see the contents before opening the package material, in order to facilitate aseptic.