GB/T 12279.2-2024 Active National standards

GB/T 12279.2-2024 Cardiovascular implants—Cardiac valve prostheses—Part 2:Surgically implanted heart valve substitutes

GB/T 12279.2-2024 Cardiovascular implants—Cardiac valve prostheses—Part 2:Surgically implanted heart valve substitutes

Publish Date: 2024-06-29 Implement Date: 2025-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 12279.2-2024

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2024-06-29

Implement Date: 2025-07-01

Publisher: 国家市场监督管理总局、国家标准化管理委员会

Technical Committee: 全国外科植入物和矫形器械标准化技术委员会(SAC/TC 110)

Pages: 36 pages

Scope

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。

Development Information

Drafting Units:

中国食品药品检定研究院、国家药品监督管理局医疗器械技术审评中心、爱德华(上海)医疗用品有限公司、兰州兰飞医疗器械有限公司、北京思达医用装置有限公司、北京市普惠生物医学工程有限公司

Drafting Persons:

刘丽、万辰杰、王春仁、李静莉、程茂波、高冠岳、王诗梦、李海平、刘万兵、代忠伟

Word Count: 50 Thousand words Pages: 36 pages

Same series standard

GB/T 12279.1-2024 Cardiovascular implants—Cardiac valve prostheses—Part 1:General requirements

Replace the following standards

GB 12279-2008 Cardiovasular implants—Cardiac valve prostheses

Referenced Standards

GB/T 12279.1-2024 Cardiovascular implants—Cardiac valve prostheses—Part 1:General requirements GB/T 16886.2-2000 Biological evaluation of medical devices—Part 2:Animal welfare requirements GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements YY/T 0640-2008 Non-active surgical implants—General requirements YY/T 0640-2016 Non-active surgical implants—General requirements YY/T 0726-2009 Instrumentation for use in association with non-active surgical implants—General requirements YY/T 0726-2020 Instrumentation for use in association with non-active surgical implants—Gerneral requirements GB/T 16886.2-2026 Biological evaluation of medical devices—Part 2:Animal welfare requirements

Adopt standards

ISO 5840-2:2021

Related Standards

GB 12264-1990 Replaced

GB 12264-1990 Artificial heart-lung machine Silicon rubber pump tube

Publish Date: 1990-01-08

GB 12279-1990 Replaced

GB 12279-1990 Cardiac valve prostheses general technical specification

Publish Date: 1990-03-26

GB 12417-1990 Replaced

GB 12417-1990 The general technological conditions of surgical metal implant

Publish Date: 1990-07-17

GB/T 13461-1992 Replaced

GB/T 13461-1992 Synthetic resin blow knee prostheses

Publish Date: 1992-06-01

GB/T 14191-1993 Replaced

GB/T 14191-1993 Terminology for prosthetics and orthotics

Publish Date: 1993-02-25

GB 14722-1993 Replaced

GB 14722-1993 Endoskeletal above knee prosthesis

Publish Date: 1993-12-04