YY 0054-2023 Active Industry standards-Medicine

YY 0054-2023 Haemodialysis equipment

Publish Date: 2023-01-13 Implement Date: 2026-01-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0054-2023

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: 2023-01-13

Implement Date: 2026-01-15

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: 22 pages

Scope

本文件规定了血液透析设备的分类、要求，描述了试验方法。
本文件适用于自动配液的血液透析设备（以下简称设备）。
本文件不适用于：
——血液透析用水处理设备；
——腹膜透析设备；
——血液灌流、血浆置换、血浆吸附设备；
——连续性血液净化设备；
——中央供液系统；
——透析液可再生的血液透析设备。

Development Information

Word Count: 39 Thousand words Pages: 22 pages

Replace the following standards

YY 0054-2010 Haemodialysis equipment

Referenced Standards

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