GB/T 14233.2-2025

Upcoming

Test methods for infusion, transfusion, injection equipment for medical use—Part 2: Biological test methods

医用输液、输血、注射器具检验方法 第2部分:生物学试验方法

Standard Type
GBT
ICS
11.040.20
CCS
C31
Status
Upcoming
Issue Date
2025-12-02
Implementation
2027-01-01
Centralized Committee
国家药监局
Issuing Authority
国家市场监督管理总局、国家标准化管理委员会

Application Summary AI generated

This standard specifies biological test methods for medical infusion, transfusion, and injection equipment, including cytotoxicity, sensitization, and pyrogenicity tests. It is applied by manufacturers and testing laboratories to evaluate the biocompatibility and safety of devices such as IV sets, blood bags, and syringes before market release. The standard ensures compliance with regulatory requirements for sterile, single-use medical products in clinical settings.

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.