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YY/T 0698.4-2009

Search Result of Chinese Standard: 'YY/T 0698.4-2009'
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Detail Information of YY/T 0698.4-2009; YY/T0698.4-2009
Description (Translated English): Packaging materials for terminal sterilized medical devices. Part 4: Paper bags. Requirements and test methods
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C31
Classification of International Standard: 11.080.040
Word Count Estimation: 10,149
Date of Issue: 2009-06-16
Date of Implementation: 2010-12-01
Quoted Standard: GB/T 465.2; GB/T 1545; GB/T 2678.6; GB/T 7408; GB/T 12914; GB 18282.1; YY 0503; YY/T 0698.3; YY 1007; EN 285; ISO 6588-2-2005; ISO 9197; ISO 11607-1
Adopted Standard: prEN 868-4-2007, IDT
Drafting Organization: Shandong Province Quality Inspection Center of Medical Devices
Administrative Organization: Jinan, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center
Regulation (derived from): Industry standard filing Notice 2009 No. 9
Proposing organization: National Standardization Technical Committee appliances Infusion
Issuing agency(ies): China Food and Drug Administration
Summary: This standard specifies the use YY/T 0698 under Part 3 of the paper bag manufacturing requirements and test methods. This part is not on ISO 11607-1 General requirements increased requirements. Thus, 4. 2 to 4. 6 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 the paper bag for terminally sterilized medical device packaging.

YY/T 0698.4-2009
Packaging materials for terminal sterilized medical devices.Part 4: Paper bags.Requirements and test methods
ICS 11.080.040
C31
People's Republic of China pharmaceutical industry standards
Terminally sterilized medical devices packaging materials
Part 4: Paper bags - Requirements and test methods
Posted 2009-06-16
2010-12-01 implementation
State Food and Drug Administration issued
Foreword
YY/T 0698 "terminally sterilized medical device packaging materials," consists of the following components:
--- Part 2: Sterilization wrap material requirements and test methods;
--- Part 3: paper (YY/T 0698.4 forth), a combination of bags and coils (YY/T 0698.5 forth) to produce paper
Sum Test methods;
--- Part 4: Paper bags - Requirements and test methods;
--- Part 5: sealable bags and coil combination requirements and test methods breathable material and plastic film composition;
--- Part 6: Requirements and test methods for the production of paper sterile barrier system or low temperature sterilization processes for radiation sterilization;
--- Part 7: ethylene oxide or radiation sterilization production sealable adhesive paper requirements and test methods for sterile barrier system;
--- Part 8: steam sterilizers repeatability requirements and test methods for sterilizing containers;
--- Part 9: combination sealable bags, and the cover sheet material production without nonwovens requirements and test methods for coating polyolefin;
--- Part 10: combination sealable bags, and the cover sheet material production nonwovens requirements and test methods for coating polyolefin.
This section YY/T Section 40698 of.
Requirements and test methods other terminally sterilized medical devices packaging material will be covered in other sections.
YY/T 0698 is identical with this part prEN868-4:2007 "terminally sterilized medical device packaging materials - Part 4: Paper
And test methods "requirements bags.
This section of the Appendices A and B are normative appendix.
This part of the National Standardization Technical Committee appliances medical infusion made.
This part of the jurisdiction of the State Food and D
Related standard:   YY/T 0698.1-2011  YY/T 0698.10-2009
   
 
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