YY/T 0698.7-2009Packaging materials for terminally sterilized medical devices - Part 7: Sealable adhesive coated paper for the manufacture of sterile barrier systems for sterilization by ethylene oxide or irradiation - 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 Section 70698 of.

Requirements and test methods other terminally sterilized medical devices packaging material will be covered in other sections.

Requirements and test methods YY other medical device packaging/T 0698 will be specified in other sections.

YY/T 0698 is identical with this part prEN868-7.2007 "terminally sterilized medical device packaging materials - Part 7. for ring Ethylene oxide or radiation sterilization of medical sterile barrier system can be sealed with adhesive paper production requirements and test methods. " This section of the Appendix A, Appendix B, Appendix C, Appendix D and Appendix E 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, Shanghai Kindly Enterprise Development Group Company 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

This section YY/T 0698 provides the requirements and test methods comply with YY/T 0698.6 of paper production sealable adhesive paper.

The packaging material used for the eventual adoption of ethylene oxide or radiation sterilization of medical device packaging.

This part is not general requirements for ISO 11607-1 requirements increase, but in ISO 11607-1, the relevant national standards on the basis of each Elements provide guidance. Thus, in the 4.2 to 4.3-specific requirements can be used to demonstrate compliance with one or more of the requirements of ISO 11607-1, but not All of its requirements.

2 Normative references

The following documents contain provisions which, through YY/T 0698 reference in this text, constitute provisions of this part. For dated reference documents Member, all subsequent amendments (not including errata content) or revisions do not apply to this section, however, encouraged to reach under this section Parties to research agreement to use 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 of GB/T 451.2-2002, eqv ISO 536:1995

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 465.1 Paper and paperboard bursting strength after immersion in water assay (GB/T 465.1-2008, ISO 3689. 1983, IDT)

GB/T 465.2 after soaking paper and board Determination of tensile strength (GB/T 465.2-2008, ISO 3781. 1983, IDT)

GB/T 1540 Determination of absorbent paper and cardboard Cobb method (GB/T 1540-2002, neq ISO 535:1991)

GB/T 1545.2 paper, board and pulp - Determination of pH of aqueous extracts (GB/T 1545.2-2003, modISO 6588. 1981)

GB/T 2678.6 paper, board and pulp - Determination of water soluble sulphates (conductometric titration) (GB/T 2678.6-1996, eqv ISO 9198. 1989)

GB/T 7408 Data elements and interchange formats - Information interchange the date and time notation (GB/T 7408-2005ISO 8601. 2001, IDT)

GB/T 7974-2002 paper, paperboard and pulp brightness (whiteness) measured diffusion/vertical method (neq ISO 2470:1999)

GB/T 12914 Paper and board - Determination of tensile strength (GB/T 12914-2008, ISO 1924-2:1994, MOD)

ISO 6588-2:2005 Paper, board and pulp - Determination of pH of aqueous extracts - Part 2. Hot Extraction

ISO 9197 Determination of paper, paperboard and pulp water-soluble chlorides Requested materials, sterile barrier systems and packaging systems. ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1

3 Terms and Definitions

Terms and definitions apply to the establishment of ISO 11607-1 YY/T 0698 to the present section.

4 Requirements