中国血液净化 ›› 2026, Vol. 25 ›› Issue (03): 177-181.doi: 10.3969/j.issn.1671-4091.2026.03.001

• 指南与共识 •    下一篇

腹膜透析设备监管现状与YY/T 1274-2025标准解读

刘锦焕   蔡海青    刘国光    王 晶   吴少海   

  1. 510663 广州,1广东省医疗器械质量监督检验所
    100076 北京,2国家药品监督管理局医疗器械技术审评中心
  • 收稿日期:2025-07-21 修回日期:2025-11-25 出版日期:2026-03-12 发布日期:2026-03-12
  • 通讯作者: 吴少海 E-mail:shaohaiwu@163.com
  • 作者简介:shaohaiwu@163.com
  • 基金资助:
    国家重点研发计划项目(2023YFC2411800)

Current Status of Peritoneal Dialysis Equipment Regulation and Interpretation of YY/T 1274-2025 Standard

LIU Jin-huan, CAI Hai-qing, LIU Guo-guang,WANG Jing,WU Shao-hai   

  1. Guangdong Medical Devices Quality Surveillance and Test Institute, Guangzhou 510663, China;2Center for Medical Device Evaluation, NMPA, Beijing 100076, China
  • Received:2025-07-21 Revised:2025-11-25 Online:2026-03-12 Published:2026-03-12
  • Contact: 510663 广州,1广东省医疗器械质量监督检验所 E-mail:shaohaiwu@163.com

摘要: YY/T 1274-2025《腹膜透析设备》行业标准于2025年发布,拟于2027年正式实施,该标准将全面替代YY/T 1493-2016《重力控制型腹膜透析设备》与YY/T 1274-2016《压力控制型腹膜透析设备》。本文通过对比新版标准与旧版标准的主要技术差异,对新版标准的关键条款进行解读,旨在为行业理解和贯彻该标准提供参考,以提升腹膜透析设备的安全性,推动行业高质量发展。

Abstract: The industry standard YY/T 1274-2025 "Peritoneal Dialysis Equipment" was released in 2025 and is scheduled for implementation in 2027. This standard will replace YY/T 1493-2016, "Gravity-Controlled Peritoneal Dialysis Equipment" and YY/T 1274-2016, "Pressure-Controlled Peritoneal Dialysis Equipment". By comparing the main technical differences between the new edition and the previous editions, this paper interprets the key clauses of the new standard, aiming to provide references for the industry to understand and implement the standard, so as to improve the safety of peritoneal dialysis equipment and promote the high-quality development of the industry.

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