YY/T 0698.6-2009Packaging materials for terminally sterilized medical devices - Part 6: Paper for the manufacture of sterile barrier systems intended for sterilization by low temperature sterilization processes 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 60698 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 prEN868-6.2007 "terminally sterilized medical device packaging materials - Part 6. a ring Ethylene oxide sterilization or radiation sterilization of the sterile barrier system of paper production requirements and test methods. " 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, Shanghai Jianzhong medical equipment Packing Co., Ltd.

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 so terminally sterilized medical devices prior to use to maintain a sterile barrier systems and preformed sterile package Requirements and test methods for the production of paper loading system.

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.

Note 1. YY/T 0698 provisions of this Part apply to paper, ethylene oxide, radiation to produce a sterile barrier system or low temperature steam formaldehyde sterilization process.

Note 2. Paper YY/T 0698.3 article may also be used for the sterilization process.

Paper expected part of this Part or all of the bags used in combination, forming - lidding seal (FFS) packaging and packaging - filled.

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 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 Research into whether the parties to the agreement to use the latest versions of these documents. For undated references, the latest version applies to This section.

GB/T 451.2 Paper and paperboard quantitative determination (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 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 paper, board and pulp - Determination of pH of aqueous extracts (GB/T 1545-2008, ISO 6588. 1981, MOD)

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 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 7408 Data elements and interchange formats - Information interchange the date and time notation (GB/T 7408-2005, ISO 8601. 2000, IDT)

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

GB/T 12914 Paper and board - Determination of tensile strength (constant speed stretching method) (GB/T 12914-1991, eqv ISO 1924-2.

1985)

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