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YY/T 1449.3-2016 English PDF

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YY/T 1449.3-2016: Cardiovascular implants--Cardiac valve prostheses--Part 3: Heart valve substitutes implanted by transcatheter techniques
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YY/T 1449.3-2016English1724 Add to Cart 5 days [Need to translate] Cardiovascular implants--Cardiac valve prostheses--Part 3: Heart valve substitutes implanted by transcatheter techniques Valid YY/T 1449.3-2016

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Basic data

Standard ID YY/T 1449.3-2016 (YY/T1449.3-2016)
Description (Translated English) Cardiovascular implants--Cardiac valve prostheses--Part 3: Heart valve substitutes implanted by transcatheter techniques
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C35
Classification of International Standard 11.040.40
Word Count Estimation 91,942
Date of Issue 2016-01-26
Date of Implementation 2017-01-01
Regulation (derived from) China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies) State Food and Drug Administration

YY/T 1449.3-2016: Cardiovascular implants--Cardiac valve prostheses--Part 3: Heart valve substitutes implanted by transcatheter techniques


---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 implants - Cardiac valve prostheses - Part 3. Heart valve fetous implanted by transcatheter techniques ICS 11.040.40 C35 People's Republic of China Pharmaceutical Industry Standard Cardiovascular Implants Artificial Heart Valves Part 3. Transcatheter implantable artificial heart valves Cardiovascularimplants-Cardiacvalveprostheses-Part 3. Heartvalve (ISO 5840-3..2013, IDT) 2016-01-26 release 2017-01-01 Implementation State Food and Drug Administration issued Directory Preface I Introduction II 1 Scope 1 2 normative reference document 1 3 Terms and definitions 2 4 Abbreviations 8 5 Basic requirements 9 6 Device description 9 7 Design Verification Test and Analysis/Design Confirmation 12 Appendix A (informative) Principles of the provisions of this standard 25 Appendix B (informative) Tubular valve illustration, assembly and delivery system Appendix C (Normative Appendix) Packaging 33 Appendix D (normative) Product labeling, instruction manual and training 34 Appendix E (normative) Sterilization 37 Appendix F (informative) Valve description 38 Appendix G (informative) Hazard of catheter valves, associated failure modes and evaluation methods 40 Appendix H (informative) Guidelines for in vitro testing of pediatric equipment 44 Appendix I (informative) Procedures for the use of performance standards 47 Appendix J (informative) Examples and definitions of physical and material properties of catheter valves and their components 48 Appendix K (informative) Standard example for artificial heart valve material and component testing 58 Appendix L (informative) Supported mechanical materials Original and treated mechanical properties 63 Appendix M (informative) Corrosion assessment 64 Appendix N (informative) Guidelines for the validation of hydrodynamic performance Appendix O (informative) Durability test 70 Appendix P (informative) Fatigue Assessment 72 Appendix Q (informative) Clinical in situ evaluation 77 Appendix R (normative appendix) Classification of adverse events during clinical research Appendix S (informative) Echocardiographic program 83 Reference 85

Foreword

YY/T 1449 "Cardiovascular Implants Artificial Heart Valves" have been or are scheduled to be published in the following sections. - Part 1. General; - Part 2. Surgical implantable artificial heart valves; - Part 3. Transcatheter implantable artificial heart valves; - Part 4. Valve repair products; Part 5. Allograft valves. This part is part 3 of YY/T 1449. This part is drafted in accordance with the rules given in GB/T 1.1-2009. This part uses the translation method equivalent to ISO 5840-3..2013 "Cardiovascular Implants Artificial Heart Valves Transcatheter Implanted Artificial Heart valve ". In this part of the normative reference to the international documents have a consistent correspondence between the following documents. GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management (ISO 10993-1..2009, IDT); GB/T 16886.2-2011 Biological evaluation of medical devices - Part 2. Animal welfare requirements (ISO 10993-2..2006, IDT); GB 18280-2000 Sterilization of health care products and routine control requirements for radiation sterilization (ISO 11137..1995, IDT); Packaging of final sterilized medical devices (ISO 11607..2003, IDT); GB/T 19633-2005; GB/T.19974-2005 Characteristics of sterilization factor for medical care products and setting of sterilization process for medical devices, confirmation And general requirements for routine control (ISO 14937..2000, IDT); GB/T 27025-2008 General requirements for the testing and calibration of laboratory capabilities (ISO /IEC 17025..2005, IDT); Clinical investigation of medical devices (ISO 14155..1996, IDT); Medical Device Risk Management for Medical Devices (ISO 14971..2007, IDT); Animal health equipment - Part 1. Risk management applications (ISO 22442-1..2007, IDT); - YY/T 0771.2-2009 Animal source medical devices - Part 2. Control of sources, collection and disposal (ISO 22442-2. 2007, IDT); - YY/T 0771.3-2009 Animal source medical device - Part 3. Virus and transmissible spongiform encephalopathy (TSE) factor In addition to confirmation of inactivation (ISO 22442-3..2007, IDT); --- YY 0970-2013 Disposable use of animal-derived materials Sterilization of sterilized liquid sterilizers for medical devices Conventional control (ISO 14160..1998, IDT). Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This section is proposed by the State Food and Drug Administration. This part of the National Surgical Implant and Orthopedic Equipment Standardization Technical Committee of cardiovascular implant sub-technical committee. This part of the drafting unit. China Food and Drug Research Institute, Tianjin Medical Device Quality Supervision and Inspection Center, Bai Ren Medical Technology Limited Company, minimally invasive medical equipment (Shanghai) Co., Ltd., Beijing University of Aeronautics and Astronautics, Xianjian Technology (Shenzhen) Co., Ltd. This part of the main drafters. Liu Li, Tang Jinglong, Wang Shuo, Wang Ying, Shang Ruyao, Fan Yubo, Zhang Deyuan, Li Miaojing, Li Yong, Li Yu, Wu Jia, Miao Hui, Li Jia, Shao Anliang, Feng Xiaoming, Wang Chunren.

Introduction

So far, there is no artificial heart valve to achieve the desired level. This section is developed by a panel of experts engaged in artificial heart valve research and its development. In order not to hinder the development of technology and innovation, this The provisions of the standard are not specified in certain areas. Therefore, this part does not specify the performance requirements of the final product, but provides the type of test, test Methods and/or requirements for test equipment and require documentation of test methods and test results. This standard is of the utmost concern Protect the quality of products to help doctors choose artificial heart valve, and easy to operate in surgery. The focus is on regulating the type of in vitro trials, clinical precursors Internal evaluation and clinical evaluation, all in vitro and clinical in-vivo evaluation and clinical evaluation of the report, as well as artificial heart valve packaging and labeling sign. The process of in vitro testing, clinical pre-in vivo evaluation and clinical evaluation is to clarify the process required before the product is put on the market and ensure that A series of questions can be quickly confirmed and processed. In addition to the mechanical properties, physical properties, chemical properties, and biocompatibility of the basic materials, the standard Contains the most important hydrodynamic performance and durability of the catheterized valve and its delivery system. This standard does not specify hydrodynamic performance and resistance The exact test method of the long-term test, but the guiding principles of the test instrument. In the field of artificial heart valve technology, this standard should be modified, updated and revised as knowledge grows and technology is improved. This standard is used in conjunction with GB 12279-2008. Cardiovascular Implants Artificial Heart Valves Part 3. Transcatheter implantable artificial heart valves

1 Scope

This section summarizes the use of risk management to validate/confirm transcatheter implantable artificial heart valves (hereinafter referred to as transcatheter valves) And the method of manufacturing, through the risk assessment to select the appropriate validation/validation test and methods. These tests include transcatheter valves and their materials And physical, chemical, biological and mechanical properties of the components, as well as clinical pre-in vivo evaluation and clinical evaluation of transcatheter valve products. This section specifies the operating conditions and performance requirements for transcatheter valves under the support of sufficient scientific and clinical data. This section applies to all devices that are expected to be implanted into the human heart via a catheter valve. This section applies both to newly developed and improved transcatheter valves, as well as to implantable catheter valves and to determine the size of the catheter Required accessories, packaging and labels. This part does not apply to artificial heart valves designed for implantation of artificial heart or cardiac assistive devices. This part does not apply to the valve in the valve structure of the artificial heart valve and allogeneic valve. This section does not give specific requirements for non-conventional surgical implantation of artificial heart valves (eg, seamless). The requirements for such equipment should be Refer to this section and the relevant terms in GB 12279-2008. Note. Appendix A describes the basic principles of the terms of this standard.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. ISO 10993-1 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management (Biologicalevalua- tionofmedicaldevices-Part 1. Evaluationandtestingwithinariskmanagementprocess) ISO 10993-2 Biological evaluation of medical devices - Part 2. Animal welfare requirements (Biologicalevaluation ofmedical devices-Part 2. Animalw purchaserequirements) ISO 11135-1 Sterilization of sterile ethylene glycol for medical care products - Part 1. Development, validation and validation of sterilization of medical devices Conventional control requirements (Sterilization ofhealthcareproducts-Ethyleneoxide-Part 1. Requirementsfordevel- opment, validationandroutinecontrolofasterilizationprocessformedicaldevices) ISO /T S11135-2 Sterilization of sterilization products for health care products - Part 2. ISO 11135-1 application guide (Sterilization ofhealthcareproducts-Ethyleneoxide-Part 2. GuidanceontheapplicationofISO 11135-1) ISO 11137-1 Sterilization of sterilization products for medical care products - Part 1. Development, validation and routine of sterilization of medical devices Control requirements (Sterilization ofhealthcare products-Radiation-Part 1. Requirementsfordevelopment, validationandroutinecontrolofasterilizationprocessformedicaldevices) ISO 11137-2 Sterilization of sterilization products for health care products - Part 2. Establishment of sterilization dose (Sterilization ofhealth careproducts-Radiation-Part 2. constructedthesterilizationdose ISO 11137-3 Sterilization of sterilization products for health care products - Part 3. Guidelines for dosimetry (Sterilization ofhealth careproducts-Radiation-Part 3. Guidanceondosimetricaspects) ISO 11607-1 Packaging of final sterilized medical devices - Part 1. Materials, sterile barrier systems and packaging system requirements (Packa- gingforterminalysterilizedmedicaldevices-Part 1. Requirementsformaterials, sterilebarriersys-

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