GB/T 19335-2022

Active

Blood flow products for single use-General specification

一次性使用血路产品 通用技术条件

Standard Type
GBT
ICS
11.040.20
CCS
C 31
Status
Active
Issue Date
2022-04-15
Implementation
2023-05-01
Centralized Committee
国家药监局
Issuing Authority
国家市场监督管理总局、中国国家标准化管理委员会

Application Summary AI generated

This standard specifies the technical requirements, test methods, and inspection rules for single-use blood flow products, such as blood tubing sets and connectors used in extracorporeal circulation. It is applied in the manufacturing and quality control of medical devices for hemodialysis, cardiopulmonary bypass, and blood transfusion procedures in healthcare settings. The standard ensures product safety, biocompatibility, and performance consistency for clinical use.

Related Standards

Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.