YY/T 0698.8-2009Packaging materials for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers—Requirements and test methods (English PDF)

Foreword

YY/T 0698 is equivalent to using this part of EN 868-8:2007 "terminally sterilized medical device packaging materials - Part 8.

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.

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

This section Appendix B, Appendix C, Appendix D, Appendix E, Appendix F is a normative appendix, Appendix A, Appendix G is informative 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, Shandong Xinhua Medical Instrument 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 the repetitive use of steam sterilization container requirements and test methods.

This part is not general requirements for ISO 11607-1 requirements increase. Thus, in the 4.2 to 4.5 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.

Container specified in this section are intended as medical devices in compliance with EN 2852) steam sterilizer sterilization packaging system, then For transport and storage equipment.

Note 1. This does not meet the EN 285 container intended for steam sterilization, the container used in the performance of a predetermined sterilization cycle confirmed by the consumer, should also Other aspects of the Adaptability of the container and the sterilization cycle shall be reviewed, such as operating temperature.

Note 2. When the device needs to be multi-layered package to meet the general requirements, devices are advised to use sterile packaging materials (such as the other part of the standard set forth in the material) package.

2 Normative references

The following documents contain provisions which, through reference in this section YY 0698 constitute provisions of this section. Cited documents dated, its All subsequent amendments (excluding corrections) or revisions do not apply to this section, however, encourage an agreement under this section Parties to study the latest versions of these documents. For undated reference documents, the latest versions apply to this section.

GB/T 1220 stainless steel rods

GB/T 5783-2000 full thread hex head bolts (eqv ISO 4017:1999)

GB/T 15596 Determination of plastic is exposed to sunlight or artificial light or natural climate color and performance changes under glass (GB/T 15596-1995, eqv ISO 4582. 1980)

ISO 11607-1:2006 final packaging sterilized medical devices - Part 1.

3 Terms and Definitions

Terms and definitions apply YY ISO 11607-1 and EN 285 established/T 0698 to the present section.

4 Requirements