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YY/T 0698.2-2009 English PDF (YYT0698.2-2009)

YY/T 0698.2-2009 English PDF (YYT0698.2-2009)

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YY/T 0698.2-2009: Packaging materials for terminal sterilized medical devices. Part 2: Sterilization wrap. Requirements and test methods

This Part of YY/T 0698 provides test methods and values for materials for preformed sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.
YY/T 0698.2-2009
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.080.040
C 31
Packaging materials for terminal sterilized medical
devices - Part 2. Sterilization wrap ?€?
Requirements and test methods
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ISSUED ON. JUNE 16, 2009
IMPLEMENTED ON. DECEMBER 1, 2010
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 6
2 Normative references ... 6
3 Terms and definitions ... 8
4 Requirements ... 8
5 Information to be supplied by the manufacturer ... 12
Annex A ... 14
Annex B ... 16
Annex C ... 21
Annex D ... 23
Bibliography ... 25
Foreword
YY/T 0698 Packaging materials for terminal sterilized medical devices consists of the following parts.
- 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. Heat and self-sealable pouches and reels of paper and plastic film construction - Requirements and test methods
- Part 6. Paper for manufacture of sterile barrier systems intended for sterilization by low temperature sterilization pro
- Part 7. Adhesive coated paper for the manufacture of sealable packs for medical use for sterilization by ethylene oxide
- Part 8. Re-usable sterilization containers for steam sterilizers -
Requirements and test methods
- Part 9. Uncoated nonwoven materials of polyolefines for use in the
manufacture of sealable pouches, reels and lids - R
- Part 10. Adhesive coated nonwoven materials of polyolefines for use in the manufacture of sealable pouches, reels and lids - Requirements and
test methods
This Part is the second part of YY/T 0698.
Other requirements and test methods for other packaging materials for terminal sterilized medical devices shall be stipulated in other parts.
This Part of YY/T 0698 refers to and adopts prEN 868-2.2007 Packaging
materials for terminal sterilized medical devices - Part 2. Sterilization wrap - Requirements and test methods.
Annex A, Annex B, Annex C and Annex D of this Part are normative.
This Part was proposed by National Technical Committee on Infusion
Equipment for Medical of Standardization Administration of China.
This Part shall be under the jurisdiction of China Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center.
Packaging materials for terminal sterilized medical
devices - Part 2. Sterilization wrap ?€?
Requirements and test methods
1 Scope
This Part of YY/T 0698 provides test methods and values for materials for preformed sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. This Part introduces no additional requirements to the general requirements specified in ISO 11607-1. As such, the particular requirements in 4.2 can be used to demonstrate compliance with one or more but not all of the
requirements of ISO 11607-1.
NOTE 1. If the intended use as specified by the manufacturer includes the possibility of the material being used as a sterile field or a surgical drape the YY/T 0506 series applies. NOTE 2. If the intended use as specified by the manufacturer includes the possibility of the material being used as container filter or as an inner wrap for containers then additional and/or other requirements can apply, see e. g. YY/T 0698.8.
2 Normative references
The following standards contain the provisions which, through reference in this Part of YY/T 0698, constitute the provisions of this Part. For dated references, subsequent amendments (excluding corrections) or revisions do not apply to this Part. However, the parties who enter into agreement based on this Part are encouraged to investigate whether the latest versions of these documents are applicable. For undated reference documents, the latest versions apply to this Part.
GB/T 451.2 Paper and board - Determination of grammage (GB/T 451.2-
2002, eqv ISO 536.1995)
GB/T 454 Paper - Determination of bursting strength (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 permeance (GB/T 458-2008, ISO 5636-2.1984, ISO 5636-3.1992, ISO 5636-5.2003, MOD)
GB/T 465.1 Paper and board - Determination of bursting strength after
immersion in water (GB/T 465.1-2008, ISO 3689.1983, IDT)
GB/T 465.2 Paper and board - Determination of tensile strength after
immersion in water (GB/T 465.2-2008, ISO 3689.1983, IDT)
GB/T 1540 Paper and board - Determination of water absorption - 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, mod ISO 6588.1981)
GB/T 2678.6 Paper, board and pulp-Determination of water soluble
sulphates (Conductimetric titration method) (GB/T 2678.6-1996, eqv ISO
9198.1989)
GB/T 3917.1-1997 Textiles - Tear properties of fabrics - Part 1. Determination of tear force - Ballistic pendulum method (Elmendorf) (GB/T 3917.1-1997, neq ISO/DIS 13937-1.1995)
GB/T 4744 Textiles - Testing and evaluation for water resistance - Hydrostatic pressure method (GB/T 4744-1997, eqv ISO 811.1981)
GB/T 4745-1997 Textile fabrics - Determination of resistance to surface wetting - Spray test (GB/T 4745-1997, eqv ISO 4920.1981)
GB/T 5453-1997 Textiles - Determination of the permeability of fabrics to air GB/T 7408 Data elements and interchange formats - Information interchange - Representation of dates and times (GB/T 7408-2005, ISO 8601.2000, IDT) GB/T 7742.1 Textiles - Bursting properties of fabrics - Part 1. Hydraulic method for determination of bursting strength and bursting distension (GB/T 7742.1-2005, ISO 13938-1.1999, MOD)
GB/T 7974-2002 Paper, board and pulp - Measurement of brightness -
Diff/Geometry (neq ISO 2470.1999)
GB/T 12914 Paper and board - Determination of tensile properties (GB/T
12914-2008, ISO 1924-2.1994, MOD)
ISO 6588-2.2005 Paper, board and pulps - Determination of pH of aqueous extracts - Part 2. Hot extraction
ISO 9073-3 Textiles - Test methods for nonwovens - Part 3. Determination of Bibliography
GB/T 10739 Paper, board and pulps standard atmosphere for conditioning and testing
GB/T 19633 Packaging for terminally sterilized medical devices
YY/T 0506.1 Surgical drapes gowns and clean air suits for patients clinical staff and equipment - Part 1. General requirements for manufacturers processors and products
EN 13795-36 Surgical Drapes, Gowns And Clean Air Suits, Used As Medical Devices For Patients, Clinical Staff And Equipment - Part 3. Performance Requirements and Performance Levels
6 YY/T 0506-2, the industrial standard corresponding to EN 13795-3 is under stipulation.

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