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YY/T 0698.6-2009 (YYT 0698.6-2009)

Chinese standards (related to): 'YY/T 0698.6-2009'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)See DetailStatusGoogle Book
YY/T 0698.1-2011English149 Add to Cart 3 days Packaging materials for terminal sterilized medical devices. Part 1: Co-extrusion plastic films used for vacuum forming packaging. Requirements and test methods YY/T 0698.1-2011 Valid YYT 0698.1-2011
YY/T 0698.6-2009English254 Add to Cart 3 days Packaging materials for terminal sterilized medical devices. Part 6: Paper for manufacture of sterile barrier systems intended for sterilization by low temperature sterilization processes or irradiation. Requirements and test methods YY/T 0698.6-2009 Valid YYT 0698.6-2009


   
BASIC DATA
Standard ID YY/T 0698.6-2009 (YY/T0698.6-2009)
Description (Translated English) Packaging materials for terminal sterilized medical devices. Part 6: Paper for manufacture of sterile barrier systems intended for sterilization by low temperature sterilization processes or irradiation. 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 13,119
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 465.1; GB/T 465.2; GB/T 1540; GB/T 1545; GB/T 2678.6; GB/T 458; GB/T 7408; GB/T 7974-2002; GB/T 12914; ISO 6588-2-2005; ISO 9197; ISO 11607-1
Adopted Standard prEN 868-6-2007, 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 terminally sterilized medical devices remain sterile before use preformed sterile barrier systems and packaging systems produce paper requirements and test methods. This part is not general requirements for ISO 11607-1 requirements increase, but in ISO 11607-1, on the basis of the relevant national standards provide guidance on the various elements. Thus, 4. 2 to 4. 3 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.