YY/T 0698.10-2009Packaging 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 (English PDF)

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.

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) EN 868-1:1997 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.

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 ASTM D2724 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