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YY/T 0698.5-2009 (YY/T0698.5-2009)

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YY/T 0698.5-2009English145 Add to Cart 0--10 minutes. Auto-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 YY/T 0698.5-2009 Valid YY/T 0698.5-2009


YY/T 0698.5-2009: PDF in English (YYT 0698.5-2009)
YY/T 0698.5-2009
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 5. Heat and self-sealable
and reels of paper and plastic film construction
– Requirements and test methods
最终灭菌医疗器械包装材料
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 ... 7 
4 Requirements ... 7 
5 Information to be supplied by the manufacturer ... 11 
Appendix A ... 12 
Appendix B ... 13 
Appendix C ... 15 
Bibliography ... 17 
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 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.
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
1 Scope
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.
2 Normative references
The provisions in following documents become the provisions of this Standard through
reference in this Standard. For dated references, the subsequent amendments
(excluding corrigendum) or revisions do not apply to this Standard, 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 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.
General requirements
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/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
3 Terms and definitions
The following terms and definitions given in ISO 11607-1 apply to this Part in YY/T
0698.
3.1 Healthcare facility
Location where patients are medically treated and medical devices are terminally
sterilized.
Such as. hospital, dentist office and practitioner.
4 Requirements
4.1 General
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
Bibliography
GB/T 10739 Paper, board and pulps - Standard atmosphere for conditioning and
testing
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
absorbent cotton and viscose gauze
YY 0503 Ethylene oxide sterilizer
YY 1007 Vertical mode steam sterilizers
ISO 11607-2 Packaging for terminally sterilized medical devices - Part 2. Validation
requirements for forming, sealing and assembly processes.
ISO 14937 Sterilization of health care products - General requirements for
characterization of a sterilizing agent and the development, validation and control of a
sterilization process for medical devices
EN 285 Sterilization - Steam sterilizers - Large sterilizers
EN1422 Sterilizers for medical purposes - Ethylene oxide sterilizers - requirements and
test methods
EN 14180 Sterilizers for medical purposes - Low temperature steam and formaldehyde
sterilizers - Requirements and testing
ASTM F 88-06 Standard test method for seal strength of flexible barrier materials
......