YY/T 1877-2022 Active Industry standards-Medicine

YY/T 1877-2022 Determination of 2,2-bis (4-hydroxyphenyl) propane (BPA) released from extracorporeal circulation devices

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 1877-2022

Standard Type: Industry 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: 2022-10-17

Implement Date: 2023-10-01

Publisher: 国家药品监督管理局

Technical Committee: 全国医用体外循环设备标准化技术委员会(SAC/TC 158)

Pages: 9 pages

Scope

本文件规定了以双酚基丙烷（BPA）为原料生产的材料所制造的体外循环器械中BPA残留量测定方法。
本文件适用于以BPA为原料生产的材料所制造的体外循环器械。
注：本文件所指体外循环器械包括血液透析器、血液透析滤过器、氧合器、血液透析管路等。

Development Information

Drafting Units:

广东省医疗器械质量监督检验所、贝恩医疗设备(广州)有限公司、山东威高血液净化制品股份有限公司、河南省驼人医疗科技有限公司、苏州百特医疗用品有限公司

Drafting Persons:

徐苏华、陈嘉晔、黄敏菊、田莉艳、陈华燕、罗洁伟、刘雨、宋修山、张菁、赵艳、刘婧群、曲亚南、温少君

Word Count: 20 Thousand words Pages: 9 pages

Referenced Standards

中华人民共和国药典(四部) 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

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