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YY/T 0698.2-2009

Chinese Standard: 'YY/T 0698.2-2009'
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YY/T 0698.2-2009English180 Add to Cart 0--15 minutes. Auto immediate delivery. Packaging materials for terminal sterilized medical devices. Part 2: Sterilization wrap. Requirements and test methods Valid YY/T 0698.2-2009
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Detail Information of YY/T 0698.2-2009; YY/T0698.2-2009
Description (Translated English): Packaging materials for terminal sterilized medical devices. Part 2: Sterilization wrap. Requirements and test methods
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C31
Classification of International Standard: 11.080.040
Word Count Estimation: 15,185
Date of Issue: 2009-06-16
Date of Implementation: 2010-12-01
Quoted Standard: GB/T 451.2; GB/T 454; GB/T 455; GB/T 458; GB/T 465.1; GB/T 465.2; GB/T 1540; GB/T 1545.2; GB/T 2678.6; GB/T 3917.1-1997; GB/T 4744; GB/T 4745-1997; GB/T 5453-1997; GB/T 7408; GB/T 7742.1; GB/T 7974-2002; GB/T 12914; ISO 6588-2-2005; ISO 9073-3; ISO 9073-9; ISO 9197; ISO 11607-1; EN 1149-1-2006
Drafting Organization: Shandong Province Quality Inspection Center of Medical Devices
Administrative Organization: Jinan, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center
Regulation (derived from): Industry standard filing Notice 2009 No. 9
Proposing organization: National Standardization Technical Committee appliances Infusion
Issuing agency(ies): China Food and Drug Administration
Summary: This standard specifies the expected before use to keep terminally sterilized medical devices preformed sterile barrier systems and packaging systems for material requirements and test methods. This part is not general requirements for ISO 11607-1 requirements increase, so that 4. 2 requirements for ISO 11607-1 can be used to demonstrate compliance with one or more of the requirements, but not all of its requirements.

YY/T 0698.2-2009
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.080.040
C 31
Packaging materials for terminal sterilized medical
devices - Part 2. Sterilization wrap –
Requirements and test methods
最终灭菌医疗器械包装材料
第 2部分. 灭菌包裹材料要求和试验方法
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 - Par......
Related standard:   YY/T 0698.1-2011  YY/T 0698.10-2009
   
 
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