YY/T 1859-2022 Active Industry standards-Medicine

YY/T 1859-2022 Anti-calcification evaluation of animal derived cardiovascular implants—Test for rat subcutaneous implantation

Publish Date: 2022-10-17 Implement Date: 2023-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1859-2022

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2022-10-17

Implement Date: 2023-10-01

Publisher: 国家药品监督管理局

Technical Committee: 全国外科植入物和矫形器械标准化技术委员会心血管植入物分技术委员会(SAC/TC 110/SC 2)

Pages: 12 pages

Scope

本文件描述了大鼠皮下植入评价动物源性心血管植入物抗钙化性能的试验方法。
本文件适用于动物源性心血管植入物的大鼠体内抗钙化性能评价试验。

Development Information

Drafting Units:

中国食品药品检定研究院、华南理工大学、金仕生物科技(常熟)有限公司、北京佰仁医疗科技股份有限公司、四川医疗器械生物材料和制品检验中心有限公司、深圳市医疗器械检测中心

Drafting Persons:

付海洋、付步芳、杜昶、刘静、金磊、李家林、王书晗、于秋航、王春仁、韩倩倩、王召旭

Word Count: 20 Thousand words Pages: 12 pages

Referenced Standards

中华人民共和国药典　2020年版　四部 GB/T 602-2002 Chemical reagent—Preparations of standard solutions for impurity GB/T 4470-1998 Analytical spectroscopic methods—Flame emission, atomic absorption and atomic fluorescence—Vocabulary GB/T 6682-1992 Water for analytical laboratory use—Specification and test methods GB/T 6682-2008 Water for analytical laboratory use—Specification and test methods GB 12279-1990 Cardiac valve prostheses general technical specification GB 12279-2008 Cardiovasular implants—Cardiac valve prostheses GB/T 12279.1-2024 Cardiovascular implants—Cardiac valve prostheses—Part 1:General requirements GB/T 12279.2-2024 Cardiovascular implants—Cardiac valve prostheses—Part 2:Surgically implanted heart valve substitutes GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process 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 GB/T 12279.3-2025 Cardiovascular implants—Cardiac valve prostheses—Part 3:Heart valve substitutes implanted by transcatheter techniques GB/T 16886.2-2026 Biological evaluation of medical devices—Part 2:Animal welfare requirements GB/T 602-2026 Chemical reagent—Preparations of standard solutions for impurity

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