GB/T 18282.1-2025

Active

Sterilization of health care products—Chemical indicators—Part 1:General requirements

医疗保健产品灭菌 化学指示物 第1部分:通则

Standard Type
GBT
ICS
11.080.01
CCS
C47
Status
Active
Issue Date
2025-01-24
Implementation
2026-02-01
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 general requirements for chemical indicators used to monitor sterilization processes for healthcare products. It is applied in hospitals, medical device manufacturers, and sterilization service facilities to verify that parameters like temperature, time, and sterilant exposure have been met during steam, ethylene oxide, or radiation sterilization cycles. The standard ensures consistent performance and interpretation of chemical indicators across different sterilization contexts.

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.