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YY/T 0698.5-2009
Chinese Standard: 'YY/T 0698.5-2009'
YY/T 0698.5-2009 English 170 Add to Cart 0--10 minutes. Auto immediate delivery. Packaging materials for terminal sterilized medical devices. Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction. Requirements and test methods Valid YY/T 0698.5-2009
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Detail Information of YY/T 0698.5-2009; YY/T0698.5-2009
Description (Translated English): Packaging materials for terminal sterilized medical devices. Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction. Requirements and test methods
Word Count Estimation: 11,162
Quoted Standard: GB/T 7408; GB 18282.1; YY/T 0698.3; YY/T 0698.6; YY/T 0698.7; YY/T 0698.9; YY/T 1698.10; ISO 11607-1; ASTM D 882-1995
Adopted Standard: prEN 868-5-2007, IDT
Summary: This standard specifies the use comply with YY/T 0698 Part 3, Part 6, Part 7, Section 9 or Section 10 breathable material and meet the provisions of this section 4. 2. 2 sealable plastic film composed of combinations of bags and roll material requirements and test methods. This part is not general requirements for ISO 11607-1 requirements increase, so that 4. 2 to 4. 5 in the special requirements of ISO 11607-1 can be used to demonstrate compliance with one or more of the requirements, but not all of its requirements. This standard specifies a sealable bag and a roll for a combination terminally sterilized medical device packaging. Combined bag and the membrane can be sealed as preformed sterile barrier systems, it is important that the user can see the contents before opening the package material, in order to facilitate aseptic.
Packaging materials for terminal sterilized
medical devices – Part 5. Heat and self-sealable
and reels of paper and plastic film construction
– Requirements and test methods
第 5部分. 透气材料与塑料膜组成的可密封组合袋和卷材
4 Requirements ... 7
5 Information to be supplied by the manufacturer ... 11
Appendix C ... 15
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 -
- Part 8. Re-usable sterilization containers for steam sterilizers - Requirements and
- 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 5 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 868-5.2007 “Packaging materials for
terminal sterilized medical devices – Part 5. Heat and self-sealable pouches and reels
of paper and plastic film construction – Requirements and test methods”.
Appendix A, appendix B and appendix C are normative.
This Part was proposed by the Standardization Technical Committee of National
Medical Infusion Equipment.
This Part shall be under the jurisdiction of Jinan Quality Inspection and supervision
Center For Medical Devices of China Food and Drug Administration.
Chief drafting organizations of this Part. Shandong Quality Inspection Center For
Medical Devices, Shanghai Jianzhong Medical Packing Co., Ltd.
Participating drafting organizations of this Part. Shanghai Kindly Enterprise
Development Group (KDL), Shandong SHINVA Medical Devices Co., Ltd.
The main drafters of this Part. Song Longfu, Yan Ning, Wang Jiuru, Wu Ping.
devices - Part 5. Heat and self-sealable and reels of
paper and plastic film construction - Requirements
This Part of YY/T 0698 provides requirements and test methods for sealable pouches
complying with the Part 3, Part 6, Part 7, Part 9 and Part 10 in YY/T 0698 and reels
manufactured from porous materials specified in 4.2.2 of this Part.
This Part adds no additional requirements to the general requirements specified in ISO
11608-1. As such, the particular requirements in 4.2~4.5 can be used to verify
compliance with one or more but not all of the requirements specified in ISO 11607-1.
Sealable pouches and reels specified in this Part apply to the packaging of medical
devices which are to be terminally sterilized.
The use of sealable pouches and reels as preformed sterile barrier systems enables
ease of presentation; most importantly, the users are able to see the contents of the
pack before it is opened.
GB/T 7408 Data elements and interchange formats – Information interchange –
Representation of data and times (GB/T 7408-2005, ISO 8601.2000, IDT)
GB 18282.1 Sterilization of health care products - Chemical indications - Part 1.
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
YY/T 0698.6 Packing material for terminal sterilized medical devices - Part 6. Paper
for manufacture of sterile barrier systems intended for sterilization by low
temperature sterilization processes or irradiation - Requirements and test methods
YY/T 0698.7 Packing material for terminal sterilized medical devices - Part 7.
Adhesive coated paper for the manufacturer of sealable packs for medical use for
sterilization by ethylene oxide or irradiation - Requirements and test methods
YY/T 0698.9 Packing material for terminal sterilized medical devices - Part 9.
Uncoated nonwoven material of polyolefines for use in the manufacture of sealable
pouches, reels and lids - Requirements and test methods
YY/T 0698.10 Packing material for terminal sterilized medical devices - Part 10.
Adhesive coated nonwoven materials of polyolefines for use in the manufacture of
sealable pouches, reels and lids - Requirements and test methods
ISO 11607-1 Packaging for terminally sterilized medical devices – Part 1.
Requirements for materials, sterile barrier systems and packaging systems
ASTM D 822.1995 Test Methods for Tensile Properties of the Thin Plastic Sheeting
The following terms and definitions given in ISO 11607-1 apply to this Part in YY/T
3.1 Healthcare facility
Location where patients are medically treated and medical devices are terminally
Such as. hospital, dentist office and practitioner.
The requirements in ISO 11607-1 apply.
Note 1. the following particular requirements and test methods can be used to verify one or more but not
GB/T 10739 Paper, board and pulps - Standard atmosphere for conditioning and
GB/T 19633 Packaging for terminally sterilized medical devices (GB/T 19633-2005,
ISO 11607.2003, IDT)
YY 0331 Performance requirements and test methods for absorbent cotton gauze and
Related PDF sample: YY/T 0698.4-2009 YY/T 0698.2-2009