GB/T 12279.2-2024 English Version, GB/T 12279.2-2024 Cardiovascular implants—Cardiac valve prostheses—Part 2:Surgically implanted heart valve substitutes (English Version)

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GB/T 12279.2-2024 Cardiovascular implants—Cardiac valve prostheses—Part 2:Surgically implanted heart valve substitutes (English Version)
Standard No.:	GB/T 12279.2-2024	Status:	to be valid remind me the status change Email:
Language:	English	File Format:	PDF
Word Count:	19000 words	Price(USD):	570.0 remind me the price change Email:
Implemented on:	2025-7-1	Delivery:	via email in 1~5 business day

Standard No.:	GB/T 12279.2-2024
English Name:	Cardiovascular implants—Cardiac valve prostheses—Part 2:Surgically implanted heart valve substitutes
Chinese Name:	心血管植入器械　人工心脏瓣膜　第2部分：外科植入式人工心脏瓣膜
Chinese Classification:	C45 Extracorporeal circulation, artificial organ and prosthesis device
Professional Classification:	GB National Standard
ICS Classification:	11.040.40 11.040.40 Implants for surgery, prosthetics and orthotics 11.040.40
Issued on:	2024-06-29
Implemented on:	2025-7-1
Status:	to be valid
Superseding:	GB 12279-2008 Cardiovasular implants - Cardiac valve prostheses
Language:	English
File Format:	PDF
Word Count:	19000 words
Price(USD):	570.0
Delivery:	via email in 1~5 business day

Standard

GB/T 12279.2-2024 Cardiovascular implants—Cardiac valve prostheses—Part 2:Surgically implanted heart valve substitutes (English Version)
Standard No.	GB/T 12279.2-2024
Status	to be valid
Language	English
File Format	PDF
Word Count	19000 words
Price(USD)	570.0
Implemented on	2025-7-1
Delivery	via email in 1~5 business day

Detail of GB/T 12279.2-2024

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Introduction of GB/T 12279.2-2024

本文件规定了外科植入式人工心脏瓣膜的操作条件和性能要求，描述了通过风险管理来验证/确认人工心脏瓣膜设计和制造的方法。通过风险评估选择适当的验证/确认试验和方法，这些试验方法包括人工心脏瓣膜及其材料、组件的物理、化学、生物及机械性能测试，还包括人工心脏瓣膜成品的临床前体内评价。
本文件适用于通常在体外循环下，采用直接可视方法植入人体的人工心脏瓣膜。本文件适用于新开发的和改良的人工心脏瓣膜，也适用于植入和确定植入人工心脏瓣膜合适尺寸所需的辅件、包装和标记。

Contents of GB/T 12279.2-2024

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Keywords:
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