YY/T 0698.4-2009Packaging materials for terminal sterilized medical devices - Part 4: Paper bags—Requirements and test methods (English PDF)

Foreword

YY/T 0698 "Packaging materials for terminal sterilized medical devices" composes of the following parts [Translator note: Part 1 is not existed]:

- Part 2: Sterilization wrap - Requirements and test methods;

- Part 3: Paper for use in the manufacture of paper bags (specified in YY/T 0698.4) and in the manufacture of pouches and reels (specified in YY/T 0698.5) - Requirements and test methods;

- Part 4: Paper bags - Requirements and test methods;

- Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods;

- Part 6: Paper for the manufacture of sterile barrier systems intended for use for sterilization by ethylene oxide or irradiation - Requirements and test methods;

- Part 7: Adhesive coated paper for the manufacture of sealable sterile barrier systems for medical use for sterilization by ethylene oxide or irradiation - Requirements and test methods;

- Part 8: Re-usable sterilization containers for steam sterilizers - Requirements and test methods;

- Part 9: Uncoated nonwoven materials of polyolefins for use in the manufacture of sealable pouches, reels and lids - Requirements and test methods;

- Part 10: Adhesive coated nonwoven materials of polyolefins for use in the manufacture of sealable pouches, reels and lids - Requirements and test methods. This Part is Part 4 of YY/T 0698.

Other requirements and test methods of packaging materials for terminal sterilized medical devices will be specified in other parts.

This Part of YY/T 0698 makes reference to prEN 868-4:2007 "Packaging materials for terminal sterilized medical devices - Part 4: Paper bags - Requirements and test methods". Appendix A and appendix B are normative.

1 Scope

This Part of YY/T 0698 provides requirements and test methods for paper bags manufactured from paper specified in Part 3 of YY/T 0698.

This Part adds no additional requirements to the general requirements specified in ISO 11608-1. As such, the particular requirements in 4.2~4.6 can be used to verify compliance with one or more but not all of the requirements specified in ISO 11607-1.

Paper bags specified in this Part applies to the packaging materials for terminal sterilized medical devices.

2 Normative references

The provisions in following documents become the provisions of this Part of YY/T 0598 through reference in this Standard. For dated references, the subsequent amendments (excluding corrigendum) or revisions do not apply to this Part, however, parties who reach an agreement based on this Standard are encouraged to study if the latest versions of these documents are applicable. For undated references, the latest edition of the referenced document applies.

GB/T 465.2 Paper and board - Determination of tensile strength after immersion in water (GB/T 465.2-2008, ISO 3781:1983, IDT)

GB/T 1545 Paper, board and pulp - Determination of pH of aqueous extracts

GB/T 2678.6 Paper, board and pulp - Determination of water soluble aulphates (conductimetric titration method) (GB/T 2678.6-1996, eqv ISO 9198:1989)

GB/T 7408 Data elements and interchange formats - Information interchange - Representation of data and times (GB/T 7408-2005, ISO 8601:2000, IDT)

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

GB 18282.1 Sterilization of health care products - Chemical indications - Part 1: General requirements

YY 0503 Ethylene oxide sterilizer

YY/T 0698.3 Packing material for terminal sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in YY/T 0698.4) and in the manufacture of pouches and reels (specified in YY/T 0698.5) - Requirements and test methods

YY 1007 Vertical mode steam sterilizers

EN 285 Sterilization - Steam sterilizers - Large sterilizers

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

ISO 9197 Paper, board and pulps - Determination of water - soluble chlorides

ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

3 Terms and definitions

The terms and definitions defined in ISO 11607-1 apply to this Part.

4 Requirements