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YY/T 1787-2021 English PDF

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YY/T 1787-2021: (Cardiovascular disease heart valve repair surgery and delivery system)
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YY/T 1787-2021English1679 Add to Cart 9 days [Need to translate] (Cardiovascular disease heart valve repair surgery and delivery system) Valid YY/T 1787-2021

Standard similar to YY/T 1787-2021

Basic data

Standard ID YY/T 1787-2021 (YY/T1787-2021)
Description (Translated English) (Cardiovascular disease heart valve repair surgery and delivery system)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Word Count Estimation 83,834
Issuing agency(ies) State Drug Administration

YY/T 1787-2021: (Cardiovascular disease heart valve repair surgery and delivery system)

---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 disease heart valve repair surgery and delivery system) ICS 11.040.40 C35 People's Republic of China Pharmaceutical Industry Standard Cardiovascular Implants Heart valve repair device and delivery system Published on 2021-09-06 2022-09-01 Implementation Released by the State Drug Administration directory Preface I 1 Scope 1 2 Normative references 1 3 Terms and Definitions 2 4 Abbreviations 10 5 Basic requirements11 6 Device Description 11 7 Design Verification Experiments and Analysis/Design Validation 14 Appendix A (informative appendix) Principles of the provisions of this standard 22 Appendix B (Informative) Hazards, Relevant Failure Modes, and Evaluation Methods of Heart Valve Repair Systems 24 Appendix C (Informative) Guidelines for In Vitro Testing of Pediatric Devices 31 Appendix D (Normative Appendix) Packaging 33 Appendix E (Normative Appendix) Product Labels, Instructions for Use and Training 34 Appendix F (Normative Appendix) Sterilization 37 Appendix G (Informative) Characteristics of Heart Valve Repair Systems 38 Appendix H (informative) Examples and definitions of some physical and material properties of heart valve repair devices and their components42 Appendix I (Informative) Standard Examples for Testing Materials and Components for Heart Valve Repair Devices 52 Appendix J (informative) Considerations for changes in device material properties after implantation55 Appendix K (informative) Corrosion Assessment 56 Appendix L (Informative Appendix) Guidelines for In Vitro Evaluation of Restorative Functional Performance 59 Appendix M (Informative) Fatigue Assessment 63 Appendix N (Informative Appendix) Durability Test 68 Appendix O (Informative) Guidelines for Design Evaluation of Delivery Systems 70 Appendix P (Informative) Additional Device Design Evaluation Requirements 72 Appendix Q (Informative) Preclinical In Vitro Performance Evaluation of Annuloplasty Rings 74 Appendix R (Informative) Preclinical In Vivo Evaluation 75 Reference 78

foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard uses the redrafted method to modify the ISO 5910.2018 "Cardiovascular Implants and Heart Valve Repair of Extracorporeal Circulation Systems" instrument". The technical differences between this standard and ISO 5910.2018 and their reasons are as follows. --- Regarding normative reference documents, this standard has made adjustments with technical differences to adapt to the technical conditions of our country and the circumstances of the adjustment. The situation is reflected in Chapter 2 "Normative References", and the specific adjustments are as follows. ● Replace ISO 10993-1 with GB/T 16886.1 which is equivalent to adopting international standards (see 7.2.3.2); ● Replace ISO 10993-2 with GB/T 16886.2 which is equivalent to adopting international standards (see 7.3.2); ● Replace ISO 17665-1 with GB 18278.1 which is equivalent to adopting international standards (see F.1); ● Replace ISO 11135-1 with GB 18279.1 which is equivalent to adopting international standards (see F.1); ● Replace ISO 11137 (all parts) with GB 18280 (all parts), the degree of consistency between the parts of the two standards as follows. ◆ GB 18280.1-2015 Sterilization Radiation for Healthcare Products Part 1.Development of Sterilization Process for Medical Devices requirements for development, validation and general control (ISO 11137-1.2006, IDT); ◆ GB 18280.2-2015 Sterilization Radiation for Healthcare Products Part 2.Establishing Sterilization Dose (ISO 11137- 2.2006,IDT); ◆ GB 18280.3-2015 Sterilizing Radiation for Healthcare Products Part 3.Guidelines for Dosimetry (ISO 11137- 3.2006,IDT); ● Replace ISO 11607 (all parts) with GB/T 19633 (all parts), the consistency process between the parts of the two standards The degrees are as follows. ◆ GB/T 19633.1-2015 Packaging of Terminally Sterilized Medical Devices Part 1.Materials, Sterile Barrier Systems and Packaging System requirements (ISO 11607-1.2006, IDT); ◆ GB/T 19633.2-2015 Packaging for Terminally Sterilized Medical Devices Part 2.Forming, Sealing and Assembly Processes recognized requirements (ISO 11607-2.2006, IDT); ● Replace ISO 14937 with GB/T.19974 which is equivalent to adopting international standards (see F.1); ● Replace ISO 13485 with YY/T 0287 which is equivalent to adopting international standards (see 6.4 and 7.1); ● Replace ISO 15223-1 with YY/T 0466.1 which is equivalent to adopting international standards (see E.1.1); ● Replace ISO 15223-2 with YY/T 0466.2 which is equivalent to adopting international standards (see E.1.1); ● Replace ISO 14630 with YY/T 0640 which is equivalent to adopting international standards (see 6.2.1, 7.2.3.1, 7.3.1, D.1, E.1.1, and F.1); ● Replace ISO 17664 with YY/T 0802 which is equivalent to adopting international standards (see F.1); ● Replace ISO 14160 with YY 0970 which is equivalent to adopting international standards (see F.1); ● Replace the revised version of ISO 14971.2007 with YY/T 0316-2016 which is equivalent to the international standard (see 3 and A.1); ● Replacing ISO 22442 (all parts) with YY/T 0771 (all parts), the degree of consistency between the parts of the two standards as follows. ◆ YY/T 0771.1-2009 Medical Devices of Animal Origin Part 1.Application of Risk Management (ISO 22442-1. 2007, IDT); ◆ YY/T 0771.2-2009 Medical Devices of Animal Origin Part 2.Control of Source, Collection and Disposal (ISO 22442-2.2007,IDT); ◆ YY/T 0771.3-2009 Medical Devices of Animal Origin Part 3.Viral and Transmissible Spongiform Encephalopathy (TSE) Validation of factor removal and inactivation (ISO 22442-3.2007, IDT); ◆ YY/T 0771.4-2015 Medical Devices of Animal Origin Part 4.Transmissible Spongiform Encephalopathy (TSE) Factors Principles for analysis of removal and/or inactivation and their process confirmation (ISO /T R22442-4.2010, IDT); --- Delete the part of 7.4 clinical research, "Technical Guidelines for Clinical Evaluation of Medical Devices" gives the relevant requirements for clinical trials. This standard has made the following editorial changes. --- Modify the standard name to "Cardiovascular Implants, Heart Valve Repair Devices and Delivery Systems", this standard does not include extracorporeal circulation System related content; --- Deleted Appendix B (Informative Appendix) "Examples of Heart Valve Repair Devices and Delivery Systems"; --- Delete Appendix Q (Informative Appendix) "Classification of Adverse Events During Clinical Research"; --- Delete Appendix R (informative appendix) "imaging scheme"; --- Deleted Appendix S (Informative Appendix) "Clinical Research Endpoints of Valve Repair Devices. Recommendations on Endpoints and Time"; --- Added Appendix Q (informative appendix) "Preclinical in vitro performance evaluation of annuloplasty rings". Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents. This standard is proposed by the State Drug Administration. This standard is approved by the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices Subcommittee on Cardiovascular Implants (SAC/TC 110/SC2) focal point. This standard was drafted by. Tianjin Medical Device Quality Supervision and Inspection Center, State Drug Administration Medical Device Technical Review Heart, Shanghai New Pulse Medical Technology Co., Ltd. The main drafters of this standard. Miao Hui, Jiao Yongzhe, Duan Qingjiao, Shi Xinli, Liu Wei, Yu Qifeng, Wen Xiantao. Cardiovascular Implants Heart valve repair device and delivery system

1 Scope

This standard specifies the operating conditions and performance requirements for heart valve repair devices and their delivery systems, if applicable. This standard applies to all repairs and/or modifications intended to act on valvular structures or adjacent anatomical structures (e.g., ventricles, coronary sinus). Heart valve repair devices that improve the function of human native heart valves (for example. valvuloplasty devices, leaflet clamping devices, artificial tendons Sow, etc.). This standard does not apply to cardiac resynchronization therapy (CRT) devices, paravalvular leak closure devices, and non-implantable systems (eg, ablation, radiofrequency valvuloplasty), apical catheters and instruments with living cell-containing components. Nor is the standard suitable for the intended use not repaired and/or modified Materials that improve the function of human heart valves (eg. mesh materials and sutures for general surgery). Note 1.YY/T 0640 specifies general requirements for the performance of passive surgical implants, this standard can be regarded as a supplement to YY/T 0640. Note 2.This standard outlines a risk management approach to verify/validate the design and manufacture of heart valve repair systems. Choose the appropriate Validation/validation tests and methods. Such tests include evaluation of the physical, chemical, biological and mechanical properties of the components and materials of the heart valve repair system. Evaluate. The trial also includes a preclinical in vivo evaluation of the finished heart valve repair system to assess the safety and efficacy of the heart valve repair system. effectiveness. Note 3.Appendix A gives the rationale for the terms of this standard.

2 Normative references

The following documents are essential for the application of this document. For dated references, only the dated version applies to this article pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in Risk Management Process (GB/T 16886. 1-2011, ISO 10993-1.2009, IDT) GB/T 16886.2 Biological Evaluation of Medical Devices Part 2.Animal Welfare Requirements (GB/T 16886.2-2011, ISO 10993-2.2006, IDT) GB 18278.1 Moist heat for sterilization of health care products - Part 1.Requirements for the development, validation and routine control of the sterilization process for medical devices Seek (GB 18278.1-2015, ISO 17665-1.2006, IDT) GB 18279.1 Sterilization of Healthcare Products Ethylene Oxide Part 1.Development, Validation and Routine Control of Sterilization Processes for Medical Devices requirements (GB 18279.1-2015, ISO 11135-1.2007, IDT) GB 18280 (all parts) Sterilizing radiation for healthcare products [ISO 11137 (all parts)] GB/T 19633 (all parts) Packaging for terminally sterilized medical devices [ISO 11607 (all parts)] GB/T.19974 Characterization of Sterilization Factors for Sterilization of Healthcare Products and Development, Validation and Routine Control of Sterilization Processes for Medical Devices General requirements for (GB/T.19974-2018, ISO 14937.2009, IDT) YY/T 0287 Medical device quality management system for regulatory requirements (YY/T 0287-2017, ISO 13485.2016, IDT) YY/T 0316-2016 Application of Medical Device Risk Management to Medical Devices (ISO 14971.2007 Corrected Edition, IDT)

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