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YY/T 0698.10-2009

Search Result of Chinese Standard: 'YY/T 0698.10-2009'
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YY/T 0698.10-2009English149 Add to Cart Days<=3 Packaging materials for terminally sterilized medical devices. Part 10: Adhesive coated nonwoven materials of polyolefines for use in the manufacture of sealable pouches, reels and lids. Requirements and test methods Valid YY/T 0698.10-2009
YY/T 0698.10-2009Chinese14 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]

   
Detail Information of YY/T 0698.10-2009; YY/T0698.10-2009
Description (Translated English): Packaging materials for terminally sterilized medical devices. Part 10: Adhesive coated nonwoven materials of polyolefines for use in the manufacture of sealable pouches, reels and lids. 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: 10,176
Date of Issue: 2009-06-16
Date of Implementation: 2010-12-01
Quoted Standard: GB/T 451.2; GB/T 451.3; GB/T 454; GB/T 455; GB/T 458; GB/T 4744; GB/T 12914; ISO 6588-2-2005; ISO 11607-1; ASTM D 2724
Adopted Standard: prEN 868-10-2007, 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 provides for terminally sterilized medical devices packaging adhesive polyolefin nonwoven material requirements and test methods. This part is not on ISO 11607-1 General requirements increased requirements. 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. Provisions of this section are expected to part or all of the material used in combination sealable bag forming Fill Seal (FFS) packaging and packaging timber lid production.


YY/T 0698.10-2009
Packaging materials for terminally sterilized medical devices.Part 10: Adhesive coated nonwoven materials of polyolefines for use in the manufacture of sealable pouches, reels and lids.Requirements and test methods
ICS 11.080.040
C31
People's Republic of China pharmaceutical industry standards
Terminally sterilized medical devices packaging materials
Part 10: sealable bags combination, and the web
Cover material production adhesive polyolefin nonwovens
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 Part of 100,698.
Requirements and test methods other terminally sterilized medical devices packaging material will be covered in other sections.
YY/T 0698 with reference to the use of this part of prEN868-10:2007 "terminally sterilized medical devices - Part 10 packing material: Seals
Bags, and the cover sheet material production nonwovens requirements and test methods "by gluing polyolefins.
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 Drug Administration Jinan Medical Device Quality Supervision and Inspection Center.
This part mainly drafted by: Shandong Province Medical Devices Product Quality Inspection Center, DuPont China Holdings Limited.
The main drafters of this section: Qian Jun, Wu Ping.
introduction
ISO 116071) standard the general title "Packaging for terminally sterilized medical devices", consists of two parts. Part 1 of this standard specifies
Expected before use to keep terminally sterilized medical devices to common sterile preformed sterile barrier systems, sterile barrier systems and packaging systems
Sum test methods. Part 2 of this standard specifies validation requirements forming, sealing and assembly processes.
Each sterile barrier system must meet the requirements of ISO 11607-1.
YY/T 0698 standard can be used to demonstrate compliance with one or more of the requirements specified in ISO 11607-1.
1) EN868-1:1997 has been ISO 11607-1:2006 is replaced. Our correspondence with the ISO 11607 standard is GB/T 19633-2005
(ISO 11607:2003, IDT). Please note that the revision of GB/T 19633 of.
Terminally sterilized medical devices packaging materials
Part 10: sealable bags combination, and the web
Cover material production adhesive polyolefin nonwovens
Requirements and test methods
1 Scope
YY/T 0698 This section provides the requirements apply to terminally sterilized medical devices packaging adhesive polyolefin material and non-woven fabric
experiment method.
This part is not general requirements for ISO 11607-1 requirements increase. Thus, in the 4.2 to 4.3 can be used to demonstrate compliance with special requirements
One or more of the requirements of ISO 11607-1, but not all of its requirements.
This Part of the material is expected to be used for part or all of seal assembly bag forming - fill - seal (FFS) packaging and lidding material
produce.
2 Normative references
The following documents contain provisions which, through reference YY/T 0698 and become part of the provisions of this section. For dated references,
All subsequent amendments (not including errata content) or revisions do not apply to this section, however, encourage the agreement on this section
Whether the parties can study the latest versions of these documents. For undated reference documents, the latest versions apply to this section.
GB/T 451.2 Paper and paperboard quantitative determination (GB/T 451.2-2002, eqv ISO 536:1995)
GB/T 451.3 Paper and board - Determination of thickness (GB/T 451.3-2002, idt ISO 534: 1988)
GB/T 454 Determination of bursting strength of paper (GB/T 454-2002, idt ISO 2758:2001)
GB/T 455 Paper and board - Determination of tearing resistance (GB/T 455-2002, eqv ISO 1974:1990)
GB/T 458 Paper and board - Determination of air permeability (GB/T 458-2008, ISO 5636-2: 1984, ISO 5636-3:1992,
ISO 5636-5:2003, MOD)
GB/T 4744 Textile fabrics - Determination of resistance to water penetration Hydrostatic pressure test (GB/T 4744-1997, eqv ISO 811: 1981)
GB/T 12914 Paper and board - Determination of tensile strength (GB/T 12914-2008, eqv ISO 1924-2:1994, MOD)
ISO 6588-2:2005 Paper, board and pulp - Determination of pH of aqueous extracts - Part 2: Hot Extraction
Requested materials, sterile barrier systems and packaging systems: ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1
ASTMD2724 paste layer, heat seal layer and test methods for composite fabric clothing
3 Terms and Definitions
Terms and definitions apply to the establishment of ISO 11607-1 YY/T 0698 to the present section.
4 Requirements
4.1 General
ISO 11607-1 apply.
NOTE: The following specific requirements and test methods can be used to demonstrate compliance with ISO 11607-1 one or more of the requirements, but not all of the requirements.
4.2 Material
4.2.1 After the adhesive material should be translucent or opaque substrate made of high purity continuous polyolefin fibers together, should not be released with sufficient
Substances to health risks.
Note: See GB/T 16886.1.
Related standard:   YY/T 0698.1-2011  YY/T 0698.2-2009
   
 
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