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

心血管植入物人工心脏瓣膜第3部分：经导管植入式人工心脏瓣膜

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

January 26, 2016

Implementation date

January 1, 2017

Scope

YY/T 1449.3-2016 is the English-translated version of 心血管植入物人工心脏瓣膜第3部分：经导管植入式人工心脏瓣膜.

YY/T 1449.3-2016 is the Chinese standard "Cardiovascular implants—Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques".

Its scope clause reads: 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. Its clauses include normative reference documents.

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Document preview — YY/T 1449.3-2016

National Standard of the People's Republic of China

ICS: 11.040.40
Classification: C 35

Issued by: National Medical Products Administration of the People's Republic of China

Preface
Introduction
1 Scope
2 normative reference document
3 Terms and definitions
4 Abbreviations
5 Basic requirements
6 Device description
7 Design Verification Test and Analysis/Design Confirmation
Appendix A (informative) Principles of the provisions of this standard
Appendix B (informative) Tubular valve illustration, assembly and delivery system
Appendix C (Normative Appendix) Packaging
Appendix D (normative) Product labeling, instruction manual and training
Appendix E (normative) Sterilization
Appendix F (informative) Valve description
Appendix G (informative) Hazard of catheter valves, associated failure modes and evaluation methods
Appendix H (informative) Guidelines for in vitro testing of pediatric equipment
Appendix I (informative) Procedures for the use of performance standards
Appendix K (informative) Standard example for artificial heart valve material and component testing
Appendix L (informative) Supported mechanical materials Original and treated mechanical properties
Appendix M (informative) Corrosion assessment
Appendix N (informative) Guidelines for the validation of hydrodynamic performance
Appendix O (informative) Durability test
Appendix P (informative) Fatigue Assessment
Appendix Q (informative) Clinical in situ evaluation
Appendix R (normative appendix) Classification of adverse events during clinical research
Appendix S (informative) Echocardiographic program

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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 85 pages — is available in the English PDF.

Referenced standards

Normative references

ISO 10993-1 · ISO 10993-2 · ISO 11135-1 · ISO/T S11135-2 · ISO 11137-1 · ISO 11137-2 · ISO 11137-3 · ISO 11607-1

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