YY/T 0663.1-2021_English: PDF (YY/T0663.1-2021)
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| YY/T 0663.1-2021 | English | 1939 |
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(Part 1: Endovascular prosthesis)
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YY/T 0663.1-2021
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| YY/T 0663.1-2014 | English | RFQ |
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Cardiovascular implant-Endovascular devices. Part 1: Endovascular prostheses
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YY/T 0663.1-2014
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| YY/T 0663-2008 | English | 999 |
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Non active surgical implants. Particular requirements for cardiac and vascular implants. Specific requirements for arterial stents
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YY/T 0663-2008
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| Standard ID | YY/T 0663.1-2021 (YY/T0663.1-2021) | | Description (Translated English) | (Part 1: Endovascular prosthesis) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C36 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 96,990 | | Date of Issue | 2021-09-06 | | Date of Implementation | 2022-09-01 | | Summary | This standard specifies requirements for the evaluation of endovascular systems (prostheses and delivery systems) (excluding intracranial systems), as well as requirements in terms of terminology, design attributes and information provided by the manufacturer. This standard applies to the treatment of aneurysms, arterial stenosis, or other vascular abnormalities or lesions (eg, dissection, transverse trauma), or to create shunts between vessels [eg, to create a transjugular intrahepatic portosystemic shunt (TIPS)] of the intravascular system. This standard also applies to balloons used to provide adequate conformance of endovascular prostheses to the vessel wall or to provide adequate conformance of overlapping prostheses, although they are not part of the endovascular system. This standard does not apply to the following: Vascular occluders, except when a contralateral iliac artery occluder is used as part of an aorto-unilateral iliac endovascular prosthesis; endovascular | | Standard ID | YY/T 0663.1-2014 (YY/T0663.1-2014) | | Description (Translated English) | Cardiovascular implant-Endovascular devices. Part 1: Endovascular prostheses | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C36 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 75,723 | | Date of Issue | 2014/6/17 | | Date of Implementation | 2015/7/1 | | Older Standard (superseded by this standard) | YY/T 0663-2008 | | Quoted Standard | GB/T 16886.1; GB 18278; GB 18279; GB 18280; GB/T 19633-2005; GB/T 19974; YY 0285.1; YY/T 0287; YY 0297; YY/T 0316; YY 0500-2004; YY/T 0640-2008; YY/T 0693-2008; YY/T 0694-2008; ISO 14160; GB/T 16886.2; GB/T 16886.3; GB/T 16886.4; GB/T 16886.5; GB/T 16886. | | Adopted Standard | ISO 25539-1-2003, IDT | | Drafting Organization | State Food and Drug Administration, Tianjin Medical Device Quality Supervision and Inspection Center | | Administrative Organization | National Surgical implants and orthopedic instruments Standardization Technical Committee Technical Committee minutes of cardiovascular implants | | Regulation (derived from) | China Food and Drug Administration in 2014 Bulletin No. 30 | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard applies to the treatment of aneurysms, arterial stenosis or other vascular malformations within the vascular prosthesis and endovascular prosthesis as part of the delivery system release. This Standard specifies the requirements for informat | | Standard ID | YY/T 0663-2008 (YY/T0663-2008) | | Description (Translated English) | Non active surgical implants. Particular requirements for cardiac and vascular implants. Specific requirements for arterial stents | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C45 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 25,268 | | Date of Issue | 2008-04-25 | | Date of Implementation | 2009-06-01 | | Quoted Standard | YY 0285.1-2004; YY 0285.4-2004; YY 00450.1-2003; YY/T 0640-2008; EN 12006-2-1998; EN 12006-3-1998; ISO 14155-1; ISO 14115-2 | | Adopted Standard | EN 14299-2004, IDT | | Drafting Organization | State Food and Drug Administration, Tianjin Medical Device Quality Supervision and Inspection Center | | Administrative Organization | National standardization technical committee of Surgical characters and orthopedic implant device | | Regulation (derived from) | SFDA [2008] No. 192 | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | China Food and Drug Administration | | Summary | This standard provides for the correction of defects or compensate for arterial stents, endovascular prosthesis and the specific requirements of the release process. This standard applies to the aorta, intracranial arteries of the neck portion of the coronary arteries, intracranial arteries, peripheral arterial, pulmonary artery, ascending aorta and visceral artery stent used and intravascular prostheses. This standard also includes for the treatment of aneurysms, arterial stenosis or other vascular abnormalities endovascular prosthesis. |
YY/T 0663.1-2014
Cardiovascular implant-Endovascular devices.Part 1. Endovascular prostheses
ICS 11.040.40
C36
People's Republic of China pharmaceutical industry standards
Section instead of YY/T 0663-2008
Cardiovascular implants - Endovascular devices - Part 1.
Endovascular prosthesis
(ISO 25539-1.2003, IDT)
Issued on. 2014-06-17
2015-07-01 implementation
China Food and Drug Administration released
Table of Contents
Preface Ⅰ
1 Scope 1
2 Normative references 1
3 Terms and definitions 2
4 3 Expected Performance
5 3 Design Properties
6 material 4
7 Design Evaluation 4
8 Manufacturing 20
Sterilization 9 20
10 Packaging 21
Properties Appendix A (informative) intravascular devices --- 23 technical and clinical issues to be considered
Annex B (informative) Laboratory analysis and testing 30
Annex C (informative) defined clinical events should be reported 33
Annex D (informative) Test Method 35
68 Supplementary Appendix E (Informative Appendix) D.5.3.19 fatigue resistance test (pulsation) analysis method
References 70
Foreword
YY/T 0663 "Cardiovascular implants - Endovascular devices" includes the following three parts.
--- Part 1. Endovascular prostheses;
--- Part 2. Vascular stents;
--- Part 3. vena cava filter.
This section YY/T Section 10663 of.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This section uses the translation method identical with ISO 25539-1.2003 "Cardiovascular implants - Endovascular devices - Part 1. endovascular prosthesis
Body "and ISO 25539-1.2003/Amd1.2005" Cardiovascular implants - Endovascular devices - Part 1. Endovascular prostheses Revision 1.
Test Methods".
This section instead of YY/T 0663-2008 section on endovascular prosthesis.
From the date of implementation of this section, YY/T repeal the relevant part of the endovascular prosthesis in 0663-2008.
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This part is proposed by the China Food and Drug Administration.
This part of the National Surgical implants and orthopedic instruments Standardization Technical Committee Technical Committee cardiovascular implants
(SAC/TC110/SC2) centralized.
This section is drafted. Tianjin State Food and Drug Administration Medical Device Quality Supervision and Inspection Center, minimally invasive medical devices (Shanghai)
Limited, the State Food and Drug Administration Medical Device Evaluation Center.
The main drafters of this section. Jiaoyong Zhe, Fan platinum, gold bamboo horse, Wangsheng Jiang, Golden State was, Li Yong, Feng Xiao Yu, Shixin Li, Jia Jianxiong, Chengmao Bo.
Cardiovascular implants - Endovascular devices - Part 1.
Endovascular prosthesis
1 Scope
Based on current medical knowledge, YY/T 0663 is clear in this part of the endovascular prosthesis requirements. General safety,
This section in terms of information expected performance, design attributes, materials, design evaluation, manufacturing, sterilization and packaging manufacturer forth requirements.
YY/T 0640 provides active surgical implants general performance requirements of this section should be seen as complementary to YY/T 0640's.
This section applies to the treatment of aneurysms, arterial stenosis or other vascular malformations in the vascular prosthesis.
This section applies to as endovascular prosthesis release component of the delivery system.
This section does not apply to intravascular occlusion devices, when the contralateral iliac artery occlusion as the aorta - iliac artery unilateral instrument components used
Except for the remaining NA products see YY/T 0640.
Placed before procedures and equipment This section does not apply to vessels within the system (as defined in 3.6), such as balloon angioplasty devices.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 16886 (all parts) Biological evaluation of medical devices [ISO 10993 (all parts)]
GB 18278 Sterilization of health care products industry validation and routine control of moist heat sterilization (GB 18278-2000,
ISO 11134.1994, IDT)
GB 18279 Medical Devices ethylene oxide sterilization validation and routine control (GB 18279-2000, ISO 11135.1994, IDT)
GB 18280 Sterilization of health care products requires validation and routine control of radiation sterilization (GB 18280-2000, ISO 11137.
1995, IDT)
GB/T 19633-2005 Packaging for terminally sterilized medical devices (ISO 11607.2003, IDT)
Set Enter properties GB/T 19974 Sterilization of health care products and medical equipment sterilization factor and routine control of a sterilization process
General requirements (GB/T 19974-2005, ISO 14937.2000, IDT)
YY 0285.1 Disposable Sterile intravascular catheters - Part 1. General requirements (YY 0285.1-2004, ISO 10555-1.
1995, IDT)
YY/T 0287 medical device quality management system for regulatory requirements (YY/T 0287-2003, ISO 13485.2003,
IDT)
YY 0297 medical device clinical investigations [ISO 14155]
YY/T 0316 Medical Devices Risk Management for Medical Device Applications (YY/T 0316-2008, ISO 14971.2007, IDT)
YY 0500-2004 cardiovascular implant artificial blood vessels (ISO 7198.1998, IDT)
YY/T 0640-2008 active surgical implants General requirements (ISO 14630.2005, IDT)
Characterization of YY/T 0693-2008 dimensional characteristics of the stent
Standard Test Method for YY/T 0694-2008 of balloon-expandable stent recoil
ISO 14160 using a liquid chemical sterilant including materials of animal origin, including single-use medical device sterilization confirmation
And conventional control (Sterilizationofsingle-usemedicaldevicesincorporatingmaterialsofanimalorigin-Vali-
dationandroutinecontrolofsterilizationbyliquidchemicalsterilants)
......
YY/T 0663-2008
Non active surgical implants.Particular requirements for cardiac and vascular implants.Specific requirements for arterial stents
ICS 11.040.40
C45
People's Republic of China pharmaceutical industry standards
Active surgical implants for cardiac and vascular implants
Particular requirements for arterial stents special requirements
(EN14299.2004, IDT)
Posted 2008-04-25
2009-06-01 implementation
State Food and Drug Administration issued
Table of Contents
Introduction Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions
4 3 Expected Performance
5 3 Design Properties
6 material 3
7 Design Evaluation 3
8 Manufacturing 13
Sterilization 9 13
10 Packaging 13
Manufacturer information 11 13
Appendix A (informative) Cross-reference table 15 specific projects
Annex B (informative) report clinical events defined 17
Annex ZA (informative) terms of reference of the standard basic requirements of EU guidelines or other provisions 20
Foreword
The standard binding ENISO 14630 and EN12006-3, provided the minimum requirements for sterile arterial stents and endovascular prosthesis and its
Test methods for the evaluation carried out.
This is equivalent to using the standard EN14299.2004 "active surgical implants - Particular requirements for cardiac and vascular implants artery stenting
Specific requirements. "
This standard Annex A, Annex B, Annex ZA is informative appendix.
This standard was proposed by the State Food and Drug Administration.
This standard by the National Surgical implants and orthopedic instruments Standardization Technical Committee.
This standard was drafted. Tianjin, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center.
The main drafters of this standard. Fan platinum, Li Libin, PROCEEDINGS, Dongshuang Peng, Wang Zuo Xiao.
Active surgical implants for cardiac and vascular implants
Particular requirements for arterial stents special requirements
1 Scope
This standard specifies the stent for correcting or compensating artery defect, the specific requirements of endovascular prosthesis and release process.
For safety reasons, in ENISO 14630 and EN12006-3, based on this standard expected performance, design attributes, materials, design Comment
Specific request price, manufacture, sterilization, packaging and information supplied by the manufacturer respect.
This standard applies to the aorta, the neck portion of intracranial arteries, coronary, intracranial arteries, peripheral arterial, pulmonary artery, and ascending aorta
Visceral arteries using stents and endovascular arterial prosthesis. This standard also includes for the treatment of aneurysms, arterial stenosis or other vascular abnormalities
Intravascular prostheses.
Note 1. This standard includes the delivery system, and as an integral part of the implant release.
Note 2. This standard includes a stent graft for plugging.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research
Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
YY 0285.1-2004 sterile single-use intravascular catheters - Part 1. General requirements (ISO 10555-1.1995, IDT)
YY 0285.4-2004 sterile single-use intravascular catheters - Part 4. Balloon dilatation catheters (ISO 10555-4.1996,
IDT)
YY 0450.1-2003 Disposable Sterile intravascular catheters accessories - Part 1. guide instrument (ISO 11070.1998,
IDT)
YY/T 0640-2008 active surgical implants General requirements (ISO 14630.1997, IDT)
EN12006-2.1998 Particular requirements for active surgical implants of cardiac and vascular implants - Part 2. endovascular prosthesis comprising
Heart valve conduit
EN12006-3.1998 Particular requirements for active surgical implants of cardiac and vascular implants - Part 3. Endovascular devices
ISO 14155-1 for human clinical investigations of medical devices - Part 1. General requirements
ISO 14155-2 Part 2 Clinical investigation of medical devices for human use. Clinical Investigation and Design
3 Terms and Definitions
EN12006-3. and the following terms and definitions established in 1998 apply to this standard.
3.1
For supporting the arterial lumen of the implantable tubular structure, including endovascular prosthesis.
3.2
Not coated or uncoated stents.
3.3
Including extracranial part of the internal carotid artery and vertebral artery.
......
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