YY/T 1787-2021Cardiovascular implants—Cardiac valve repair devices and delivery system (English PDF)

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) […]