YY/T 0698.5-2023_English: PDF (YY/T0698.5-2023)
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Packaging materials for terminal sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
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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
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YY/T 0698.5-2009
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| Standard ID | YY/T 0698.5-2023 (YY/T0698.5-2023) | | Description (Translated English) | Packaging materials for terminal sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - 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Count Estimation | 20,247 | | Date of Issue | 2023-09-05 | | Date of Implementation | 2024-09-15 | | Older Standard (superseded by this standard) | YY/T 0698.5-2009 | | Drafting Organization | Shandong Medical Device and Drug Packaging Inspection Institute, DuPont (China) R&D Management Co., Ltd., Shanghai Jianzhong Medical Device Packaging Co., Ltd., Shandong Xinhua Medical Device Co., Ltd., Zhejiang Kindly Medical Device Co., Ltd. | | Administrative Organization | National Technical Committee on Standardization of Medical Infusion Equipment (SAC/TC 106) | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the requirements and test methods for sealable combination bags and rolls composed of breathable materials that comply with YY/T 0698.2, 0698.3, 0698.6, 0698.7, 0698.9 or 0698.10 and plastic films that comply with Clause 4 of this document. These sealable combination bags and rolls can be used as sterile barrier systems and/or packaging systems to maintain the sterility of terminally sterilized medical devices until use. In addition to the general requirements specified in GB/T 19633.1 and GB/T 19633.2, this standard specifies specific requirements and test methods for the materials covered by this part. This document applies only to packaging materials for single-use terminally sterilized medical devices. | | Standard ID | 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 | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.080.040 | | Word Count Estimation | 11,171 | | Date of Issue | 2009-06-16 | | Date of Implementation | 2010-12-01 | | 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 | | 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 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. |
YY/T 0698.5-2023. Packaging materials for terminally sterilized medical devices Part 5. Requirements and test methods for sealable combination bags and rolls composed of breathable materials and plastic films
ICS 11.080.040
CCSC31
Pharmaceutical Industry Standards of the People's Republic of China
Replace YY/T 0698.5-2009
Terminal sterilization medical device packaging materials
Part 5.Breathable materials and plastic films
Requirements and test methods for sealable combination bags and rolls
Published on 2023-09-05 Implemented on 2024-09-15
Released by the State Drug Administration
Table of contents
Preface III
Introduction IV
1 range 1
2 Normative reference documents 1
3 Terms and Definitions 1
4 Requirements 2
4.1 General 2
4.2 Material 2
4.3 Structure and Design 2
4.4 Process indicators 3
4.5 Performance requirements and test methods 3
4.6 Identification 3
5 Information provided by the manufacturer4
Appendix A (normative) Determination method of resistance to expected sterilization process 5
A.1 Preparation of specimen 5
A.2 Step 5
A.3 Test report 5
Appendix B (Normative) Determination method for pinholes in plastic films 6
B.1 Instruments and Reagents 6
B.2 Preparation of test pieces 6
B.3 Step 6
B.4 Test report 6
Appendix C (Normative) Method for determination of strength of sealing joint between combination bag and roll material 7
C.1 Principle 7
C.2 Test method 7
C.3 Test Preparation---Sampling Instructions 7
C.4 Step 7
C.5 Test report 8
Appendix D (Normative) Method for determination of peel properties of paper/plastic combination products 9
D.1 Equipment 9
D.2 Procedure 9
D.3 Test report 9
Appendix E (normative) Fiber direction determination method 10
E.1 Instrument 10
E.2 Step 10
E.3 Test report10
Reference 11
Preface
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents"
Drafting.
This document is Part 5 of YY/T 0698 "Packaging Materials for Terminal Sterilization Medical Devices". YY/T 0698 has released the following
part.
---Part 1.Requirements and test methods for co-extruded plastic films for blister packaging;
---Part 2.Sterilization packaging material requirements and test methods;
---Part 3.Paper requirements for the production of paper bags (specified in YY/T 0698.4), combination bags and rolls (specified in YY/T 0698.5)
and test methods;
---Part 4.Paper bag requirements and test methods;
---Part 5.Requirements and test methods for sealable combination bags and rolls composed of breathable materials and plastic films;
---Part 6.Requirements and test methods for paper production of sterile barrier systems used in low-temperature sterilization processes or radiation sterilization;
---Part 7.Requirements and test methods for sealable gummed paper used in the production of ethylene oxide or radiation sterilized sterile barrier systems;
---Part 8.Requirements and test methods for reusable sterilization containers for steam sterilizers;
---Part 9.Material requirements and test methods for unglued polyolefin nonwovens used in the production of sealable combination bags, rolls and covers;
---Part 10.Material requirements and test methods for rubberized polyolefin nonwovens used in the production of sealable combination bags, rolls and covers.
This document replaces YY/T 0698.5-2009 "Terminal Sterilization Medical Device Packaging Materials Part 5.Breathable Materials and Plastic Film Groups"
"Requirements and test methods for sealable combination bags and rolls", compared with YY/T 0698.5-2009, except for structural adjustments and editorial changes
In addition, the main technical changes are as follows.
a) Changed the “scope” (see Chapter 1, Chapter 1 of the.2009 edition);
b) The term “medical institution” is deleted (see 3.1 of the.2009 version);
c) "4.2.1 Breathable Materials" adds the content "Breathable materials should comply with the requirements of YY/T 0698 Part 2" (see 4.2.1);
d) Added requirements for peeling characteristics and peeling direction to minimize fiber damage (see 4.5.2 and 4.5.3);
e) Changed some contents of "4.6.1 Combination bags and rolls" and "4.6.2 Transport and/or storage packaging" (see 4.6.1, 4.6.2,
2009 version 4.6.1, 4.6.2);
f) Changed the content of the method for measuring the strength of the sealed connection between the combination bag and the roll material, and added an illustration of the sealing example (see Appendix C,
Appendix C of the.2009 edition);
g) Added the method for measuring the peeling characteristics of paper/plastic combination products (see Appendix D);
h) Added fiber direction determination method (see Appendix E).
Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents.
This document is proposed by the National Medical Products Administration.
This document is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Equipment (SAC/TC106).
This document was drafted by. Shandong Medical Device and Drug Packaging Inspection Institute, DuPont (China) R&D Management Co., Ltd., Shanghai Construction
China Medical Device Packaging Co., Ltd., Shandong Xinhua Medical Device Co., Ltd., and Zhejiang Kindly Medical Device Co., Ltd.
The main drafters of this document. Wang Dongwei, Qian Jun, Wang Youqiong, Han Xingwei, Zhang Bo, Chen Fang, Zhang Qian.
introduction
The general title of the GB/T 19633 series of standards is "Terminal Sterilization Medical Device Packaging" and consists of two parts. Part 1 of the standard series
Preformed sterile barrier systems, sterile barrier systems and packaging systems intended to maintain the sterility of terminally sterilized medical devices until use
General requirements and test methods, Part 2 specifies the validation requirements for forming, sealing and assembly processes.
GB/T 19633.1 provides general requirements for packaging of terminally sterilized medical devices.
The YY/T 0698 series of standards can be used to confirm compliance with one or more requirements specified in GB/T 19633.YY/T 0698 is intended to regulate
Fanhe promotes the development and progress of this type of industry and plans to consist of the following parts.
---Part 1.Requirements and test methods for co-extruded plastic films for blister packaging;
---Part 2.Sterilization packaging material requirements and test methods;
---Part 3.Paper requirements for the production of paper bags (specified in YY/T 0698.4), combination bags and rolls (specified in YY/T 0698.5)
Sum test method;
---Part 4.Paper bag requirements and test methods;
---Part 5.Requirements and test methods for sealable combination bags and rolls composed of breathable materials and plastic films;
---Part 6.Requirements and test methods for paper production of sterile barrier systems used in low-temperature sterilization processes or radiation sterilization;
---Part 7.Requirements and test methods for sealable gummed paper used in the production of ethylene oxide or radiation sterilized sterile barrier systems;
---Part 8.Requirements and test methods for reusable sterilization containers for steam sterilizers;
---Part 9.Material requirements and test methods for unglued polyolefin nonwovens used in the production of sealable combination bags, rolls and covers;
---Part 10.Material requirements and test methods for rubberized polyolefin nonwovens used in the production of sealable combination bags, rolls and covers.
Terminal sterilization medical device packaging materials
Part 5.Breathable materials and plastic films
Requirements and test methods for sealable combination bags and rolls
1 Scope
This document specifies the breathable materials complying with YY/T 0698.2, 0698.3, 0698.6, 0698.7, 0698.9 or 0698.10 and complying with this document
Requirements and test methods for sealable combination bags and rolls composed of plastic films specified in Chapter 4 of this document. These sealable combination bags and rolls are available
Create a sterile barrier system and/or packaging system to ensure the sterility of terminally sterilized medical devices until use.
In addition to the general requirements specified in GB/T 19633.1 and GB/T 19633.2, this document specifies specific requirements for the materials covered by this section.
Sum test method.
This document applies only to packaging materials for single-use terminally sterilized medical devices.
2 Normative reference documents
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations
For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to
this document.
GB/T 7408 Data elements and exchange format information exchange date and time representation
GB 18282.1 Chemical indicators for sterilization of health care products Part 1.General principles
GB/T 19633.1 Packaging of terminally sterilized medical devices Part 1.Requirements for materials, sterile barrier systems and packaging systems
YY/T 0681.2 Test methods for sterile medical device packaging Part 2.Sealing strength of soft barrier materials
YY/T 0698.2 Packaging materials for terminally sterilized medical devices Part 2.Requirements and test methods for sterilization packaging materials
YY/T 0698.3 Packaging materials for terminally sterilized medical devices Part 3.Paper bags (specified in YY/T 0698.4), combination bags and rolls
Material (YY/T 0698.5 specified) paper production requirements and test methods
YY/T 0698.6 Packaging materials for terminally sterilized medical devices Part 6.Sterile screens for low-temperature sterilization processes or radiation sterilization
Paper requirements and test methods for barrier system production
YY/T 0698.7 Packaging materials for terminally sterilized medical devices Part 7.Production of sterile barrier systems for ethylene oxide or radiation sterilization
Requirements and test methods for sealable gummed paper for production use
YY/T 0698.9 Packaging materials for terminally sterilized medical devices Part 9.Glue-free production of sealable combination bags, rolls and covers
Material requirements and test methods for polyolefin nonwovens
YY/T 0698.10 Packaging materials for terminally sterilized medical devices Part 10.Glue for the production of sealable combination bags, rolls and covers
Material requirements and test methods for polyolefin nonwovens
3 Terms and definitions
The terms and definitions defined in GB/T 19633.1 apply to this document.
......
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
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