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YY/T 0698.4-2009

Chinese Standard: 'YY/T 0698.4-2009'
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YY/T 0698.4-2009English170 Add to Cart 0--15 minutes. Auto immediate delivery. Packaging materials for terminal sterilized medical devices. Part 4: Paper bags. Requirements and test methods Valid YY/T 0698.4-2009
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Detail Information of YY/T 0698.4-2009; YY/T0698.4-2009
Description (Translated English): Packaging materials for terminal sterilized medical devices. Part 4: Paper bags. 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: 10,149
Date of Issue: 2009-06-16
Date of Implementation: 2010-12-01
Quoted Standard: GB/T 465.2; GB/T 1545; GB/T 2678.6; GB/T 7408; GB/T 12914; GB 18282.1; YY 0503; YY/T 0698.3; YY 1007; EN 285; ISO 6588-2-2005; ISO 9197; ISO 11607-1
Adopted Standard: prEN 868-4-2007, IDT
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 use YY/T 0698 under Part 3 of the paper bag manufacturing requirements and test methods. This part is not on ISO 11607-1 General requirements increased requirements. Thus, 4. 2 to 4. 6 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 the paper bag for terminally sterilized medical device packaging.

GB 6537-2006
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 4. Paper bags –
Requirements and test methods
最终灭菌医疗器械包装材料
第 4部分. 纸袋 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 ... 7 
4 Requirements ... 7 
5 Information to be supplied by the manufacturer ... 10 
Appendix A ... 11 
Appendix B ... 12 
Bibliography ... 13 
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 4 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 868-4.2007 “Packaging materials for
terminal sterilized medical devices – Part 4. Paper bags – Requirements and test
methods”.
Appendix A and appendix B 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 Kindly Enterprise Development Group (KDL).
Participating drafting organization of this Part. Shanghai Jianzhong Medical Packing
Co., Ltd.
The main drafters of this Part. Yan Ning, Song Longfu, Zhang Honghui, Li Junsheng.
Introduction
The heading of the standard ISO 116071 is Packing for terminally sterilized medical
devices, which consists of two parts. Part 1 of this Standard specifies general
requirements and test methods for materials, preformed sterility barrier systems, sterile
barrier systems and packaging systems that are intended to maintain sterility of
terminally sterilized medical devices before using. Part 2 of this Standard specifies
validation requirements for forming, sealing and assembly processes.
Every sterile barrier system must meet the requirements of ISO 11607-1.
YY/T 0698 can be used to verify compliance with one or more requirements specified
in ISO 11607-1.
1 EN 868-1.1997 was replaced by ISO 11607-1.2006. The corresponding standard to ISO
11607 is GB/T 19633-2005 (idt ISO 11607.2003). Pay attention to the revision of GB/T 19633.
Packaging materials for terminal sterilized medical
devices - Part 4. Paper bags - Requirements and test
methods
1 Scope
This Part of YY/T 0698 provides requirements and test methods for paper bags
manufactured from paper specified in Part 3 of YY/T 0698.
This Part adds no additional requirements to the general requirements specified in ISO
11608-1. As such, the particular requirements in 4.2~4.6 can be used to verify
compliance with one or more but not all of the requirements specified in ISO 11607-1.
Paper bags specified in this Part applies to the packaging materials for terminal
sterilized medical devices.
2 Normative references
The provisions in following documents become the provisions of this Part of YY/T 0598
through reference in this Standard. For dated references, the subsequent amendments
(excluding corrigendum) or revisions do not apply to this Part, 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 465.2 Paper and board – Determination of tensile strength after immersion in
water (GB/T 465.2-2008, ISO 3781.1983, IDT)
GB/T 1545 Paper, board and pulp - Determination of pH of aqueous extracts
GB/T 2678.6 Paper, board and pulp – Determination of water soluble aulphates
(conductimetric titration method) (GB/T 2678.6-1996, eqv ISO 9198.1989)
GB/T 7408 Data elements and interchange formats – Information interchange –
Representation of data and times (GB/T 7408-2005, ISO 8601.2000, IDT)
GB/T 12914 Paper and board – Determination of tensile properties GB/T 12914-
2008, ISO 1924-2.1994, MOD)
GB 18282.1 Sterilization of health care products - Chemical indications - Part 1.
General requirements
YY 0503 Ethylene oxide sterilizer
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 1007 Vertical mode steam sterilizers
EN 285 Sterilization - Steam sterilizers - Large sterilizers
ISO 6588-2.2005 Paper, board and pulp - Determination of pH of aqueous extracts
– Part 2. Hot extraction
ISO 9197 Paper, board and pulps – Determination of water – soluble chlorides
ISO 11607-1 Packaging for terminally sterilized medical devices – Part 1.
Requirements for materials, sterile barrier systems and packaging systems
3 Terms and definitions
The terms and definitions defined in ISO 11607-1 apply to this Part.
4 R......
Related standard:   YY/T 0698.1-2011  YY/T 0698.10-2009
   
 
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