GB/T 47144-2026

Upcoming

Requirements for development, validation and routine control of cleaning process for medical devices

医疗器械清洁过程的开发、确认和常规控制的要求

Standard Type
GBT
ICS
11.080.01
CCS
C 47
Status
Upcoming
Issue Date
2026-01-28
Implementation
2027-08-01
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 the requirements for developing, validating, and routinely controlling cleaning processes for medical devices. It is applied by manufacturers and healthcare facilities to ensure that reusable or reprocessed devices are effectively cleaned of contaminants, such as blood or tissue, prior to disinfection or sterilization. The standard covers testing contexts like process validation protocols and routine monitoring in hospitals or device production 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.