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YY/T 0663.1-2021 English PDF

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YY/T 0663.1-2021: (Part 1: Endovascular prosthesis)
Status: Valid

YY/T 0663.1: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0663.1-2021English1939 Add to Cart 10 days [Need to translate] (Part 1: Endovascular prosthesis) Valid YY/T 0663.1-2021
YY/T 0663.1-2014EnglishRFQ ASK 9 days [Need to translate] Cardiovascular implant-Endovascular devices. Part 1: Endovascular prostheses Obsolete YY/T 0663.1-2014
YY/T 0663-2008English999 Add to Cart 4 days [Need to translate] Non active surgical implants. Particular requirements for cardiac and vascular implants. Specific requirements for arterial stents Obsolete YY/T 0663-2008

PDF similar to YY/T 0663.1-2021


Standard similar to YY/T 0663.1-2021

YY/T 1470   YY/T 0979   YY 0091   YY/T 0663.2   YY 0336   YY/T 0663.3   

Basic data

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
Word Count Estimation 96,927
Issuing agency(ies) State Drug Administration

YY/T 0663.1-2014: Cardiovascular implant-Endovascular devices. Part 1: Endovascular prostheses

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
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)

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