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YY/T 0698.3-2009Packaging materials 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 (English PDF)

最终灭菌医疗器械包装材料 第3部分:纸袋(YY/T 0698.4所规定)、组合带和卷材(YY/T 0698.5所规定)生产用纸 要求和试验方法

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

June 16, 2009

Implementation date

December 1, 2010

Scope

YY/T 0698.3-2009 is the English-translated version of 最终灭菌医疗器械包装材料 第3部分:纸袋(YY/T 0698.4所规定)、组合带和卷材(YY/T 0698.5所规定)生产用纸 要求和试验方法.

YY/T 0698.3-2009 is the Chinese standard "Packaging materials 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".

Its scope clause reads: YY/T 0698 This section provides a paper bag (YY/T 0698.4 forth), a combination of bags and coils (YY/T 0698.5 prescribed) Requirements and test methods for the production of paper.

This part is not general requirements for ISO 11607-1 requirements increase, so that 4.2 can be used to demonstrate compliance with requirements for One or more of the requirements of ISO 11607-1, but not all of its requirements.

This Part of the paper is suitable for terminally sterilized medical devices Medical packaging. Note. For sterilization methods specified by the manufacturer. Its clauses include terms and definitions.

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Document preview — YY/T 0698.3-2009

National Standard of the People's Republic of China

Classification
C 31

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Foreword
  • Introduction
  • 1 Scope
  • 2 Normative references
  • 3 Terms and Definitions

1 Scope

YY/T 0698 This section provides a paper bag (YY/T 0698.4 forth), a combination of bags and coils (YY/T 0698.5 prescribed)

Requirements and test methods for the production of paper.

This part is not general requirements for ISO 11607-1 requirements increase, so that 4.2 can be used to demonstrate compliance with requirements for

One or more of the requirements of ISO 11607-1, but not all of its requirements.

This Part of the paper is suitable for terminally sterilized medical devices Medical packaging.

Note. For sterilization methods specified by the manufacturer.

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 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 5636-3.1992, 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 paper, paperboard and pulp extracts water acidity and alkalinity assay (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 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 (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.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

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