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GB/T 12279.2-2024: Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
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Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
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GB/T 12279.2-2024
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Basic data | Standard ID | GB/T 12279.2-2024 (GB/T12279.2-2024) | | Description (Translated English) | Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C45 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 33,386 | | Date of Issue | 2024-06-29 | | Date of Implementation | 2025-07-01 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | | Summary | This standard specifies the operating conditions and performance requirements of surgical implantable artificial heart valves, and describes methods for verifying/confirming the design and manufacture of artificial heart valves through risk management. Appropriate verification/confirmation tests and methods are selected through risk assessment. These test methods include physical, chemical, biological and mechanical performance tests of artificial heart valves and their materials and components, as well as preclinical in vivo evaluation of finished artificial heart valves. This standard applies to artificial heart valves that are usually implanted in the human body using direct visual methods under extracorporeal circulation. This standard applies to newly developed and improved artificial heart valves, as well as the accessories, packaging and markings required for implantation and determination of the appropriate size of implanted artificial heart valves. | GB/T 12279.2-2024: Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
---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.
ICS 11.040.40
CCSC45
National Standard of the People's Republic of China
Partially replaces GB 12279-2008
Cardiovascular implantable devices Artificial heart valves
Part 2.Surgically implantable prosthetic heart valves
(ISO 5840-2.2021,MOD)
Released on 2024-06-29
2025-07-01 Implementation
State Administration for Market Regulation
The National Standardization Administration issued
Table of contents
Preface III
Introduction V
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Abbreviations 3
5 Basic Requirements 3
6 Device Description 3
7 Design Verification/Validation 5
Appendix A (Informative) Hazard Analysis Example for Surgical Implantable Heart Valve10
Appendix B (Informative) In vitro test procedure for compliance of valves without a valve frame or similar structure 11
Appendix C (Informative) Preclinical in vivo evaluation 12
Appendix D (Informative) Surgical implantable prosthetic heart valve and system description 14
Appendix E (Informative) Examples of surgically implantable artificial heart valves and systems 16
Appendix F (Informative) Fluid Dynamics Performance Verification Guidelines - Pulsating Flow Test 20
Appendix G (Informative) Test examples for specific designs 22
Appendix H (Informative) Fatigue Assessment 24
Reference 26
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting is required.
This document is Part 2 of GB/T 12279 Cardiovascular Implantable Devices - Artificial Heart Valves. GB/T 12279 has been published.
The following parts.
--- Part 1.General requirements;
--- Part 2.Surgical implantable prosthetic heart valves.
This document partially replaces GB 12279-2008 Cardiovascular Implants - Artificial Heart Valves.
The requirements for use have been incorporated into GB/T 12279.1-2024.Compared with GB 12279-2008, this document has structural adjustments and editorial changes.
In addition to the above, the main technical changes are as follows.
a) Added a chapter on “Abbreviations” (see Chapter 4);
b) Added a chapter on “Basic Requirements” (see Chapter 5);
c) Added a chapter on “Device Description” (see Chapter 6);
d) “Packaging, labeling and sterilization” was changed (see 6.3.3, Chapter 10 of the.2008 edition);
e) Added “Minimum performance requirements for devices - aortic valve” (see Table 1 in 7.2.4);
f) Added “Minimum performance requirements for devices - mitral valve” (see Table 2 in 7.2.4);
g) Changed "Implant durability assessment" (see 7.2.5.2, Chapter 7 of the.2008 edition);
h) Added “Fatigue assessment of structural components of the device” (see 7.2.5.3);
i) Added “component corrosion assessment” (see 7.2.5.4);
j) Added "cavitation (mechanical valve)" (see 7.2.5.5);
k) Added “tests for specific designs or processes” (see 7.2.6);
l) Added “Device MRI compatibility” (see 7.2.7);
m) Added "simulated use" (see 7.2.8);
n) Added “Human factors/usability assessment” (see 7.2.9);
o) Added “Evaluation of implant thrombosis and hemolytic potential” (see 7.2.10).
This document is modified to adopt ISO 5840-2.2021 “Cardiovascular implantable devices - Prosthetic heart valves - Part 2.Surgical implantable prosthetic heart valves”
Heart Valves.
This document has the following structural adjustments compared to ISO 5840-2.2021.
--- 7.4 in ISO 5840-2.2021 was deleted;
--- Table F.1 corresponds to Table F.2 in ISO 5840-2.2021;
--- Deleted the normative Annexes I and J in ISO 5840-2.2021.
The technical differences between this document and ISO 5840-2.2021 and their reasons are as follows.
--- Replaced ISO 5840-1.2021 with the normative reference GB/T 12279.1-2024 (see 7.2.5, 7.2.7, 7.2.8, 7.2.9 and
7.2.10) to adapt to my country's technical conditions and increase operability;
--- Replaced ISO 10993-2 (see 7.3.2) with the normative reference GB/T 16886.2 to adapt to my country's technical conditions and increase
Operability;
--- ISO 14630 (see 7.3.1) has been replaced by the normative reference YY/T 0640 to adapt to my country's technical conditions and increase operability.
Sexuality;
--- Replaced ISO 16061 (see 6.3.2.3) with the normative reference YY/T 0726 to adapt to my country's technical conditions and increase the
Operability;
--- Added the appendix content description (see 6.3.2.1);
--- Deleted "Clinical studies" (see 7.4 of ISO 5840-2.2021), normative Annex I "Evaluation of clinical studies based on objective performance criteria"
to avoid any conflict with the “Methods for the Evaluation of Adverse Events during Clinical Studies” and the normative Appendix J “Classification of Adverse Events during Clinical Studies”
Evaluation Technical Guidelines.
The following editorial changes were made to this document.
--- Replaced ISO 14971 (see A.1) with the informative reference GB/T 42062 and GB/T 39381.1-2020
ISO 12417-1.2015 (see D.2);
--- Notes are added to Table C.1 (see Appendix C);
--- Deleted the recommended reference valve information in Table F.1 of Appendix F and the description of the reference valve in F.2.2.2.
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices (SAC/TC110).
This document was drafted by. China Food and Drug Inspection Institute, National Medical Products Administration Medical Device Technical Evaluation Center, Edwards
(Shanghai) Medical Supplies Co., Ltd., Lanzhou Lanfei Medical Equipment Co., Ltd., Beijing Star Medical Device Co., Ltd., Beijing Puhui Biotechnology Co., Ltd.
MEDICAL ENGINEERING LIMITED.
The main drafters of this document are. Liu Li, Wan Chenjie, Wang Chunren, Li Jingli, Cheng Maobo, Gao Guanyue, Wang Shimeng, Li Haiping, Liu Wanbing,
Dai Zhongwei.
The previous versions of this document and the documents it replaces are as follows.
--- First issued as GB 12279-1990 in.1990 and first revised in.2008;
Introduction
This document was developed for surgically implantable prosthetic heart valves and specifies the types of in vitro tests and preclinical in vivo evaluations, as well as all
The purpose is to clarify the procedures required before the product is put on the market and to enable rapid
Identify and manage follow-up issues.
GB/T 12279 Cardiovascular implantable devices - artificial heart valves aims to provide requirements and
The test method is planned to consist of three parts.
--- Part 1.General requirements. The purpose is to provide general requirements for artificial heart valves.
--- Part 2.Surgical implantable artificial heart valves. The purpose is to give specific requirements for surgical implantable artificial heart valves.
--- Part 3.Transcatheter implantable artificial heart valve. The purpose is to give the specific
Require.
This document needs to be used in conjunction with GB/T 12279.1 and ISO 5840-3.
For some special device designs of artificial heart valves (e.g., suture-free), it is necessary to refer to this document and
Relevant requirements of ISO 5840-3.
Cardiovascular implantable devices Artificial heart valves
Part 2.Surgically implantable prosthetic heart valves
1 Scope
This document specifies the operating conditions and performance requirements for surgically implantable prosthetic heart valves and describes the risk management approach to verify/validate
Methods for designing and manufacturing artificial heart valves. Appropriate verification/confirmation tests and methods are selected through risk assessment. These test methods include
Physical, chemical, biological and mechanical performance testing of artificial heart valves and their materials and components, including clinical precursors of finished artificial heart valves
Internal evaluation.
This document applies to artificial heart valves that are usually implanted in the human body under extracorporeal circulation using direct visualization.
Developed and improved artificial heart valves, as well as accessories, packaging and
mark.
2 Normative references
The contents of the following documents constitute essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 12279.1-2024 Cardiovascular implantable devices - Artificial heart valves - Part 1.General requirements (ISO 5840-1.
2021,MOD)
GB/T 16886.2 Biological evaluation of medical devices Part 2.Animal welfare requirements (GB/T 16886.2-2011,
ISO 10993-2.2006, IDT)
YY/T 0640 General requirements for passive surgical implants (YY/T 0640-2016, ISO 14630.2012, IDT)
YY/T 0726 General requirements for passive surgical implants and associated devices (YY/T 0726-2020, ISO 16061.2015, MOD)
3 Terms and definitions
The terms and definitions defined in GB/T 12279.1-2024 and the following apply to this document.
3.1
acute assessment
Intraoperative and immediate postoperative outcomes for evaluation of in vivo safety and performance.
NOTE. All animals entering acute short-term assessments will remain under general anesthesia for the duration of the study.
3.2
Chronic assessment
Long-term outcomes after surgery are assessed for chronic in vivo safety and performance of animals after recovery from anesthesia.
NOTE. The endpoints and duration of such studies will be determined through risk analysis.
3.3
component-joiningmaterial
Materials such as sutures, adhesives or welding compounds used to assemble heart valve systems.
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