GB/T 18280.3-2025

Upcoming

Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects of development, validation and routine control

医疗产品灭菌 辐射 第3部分:开发、确认和常规控制的剂量测量指南

Standard Type
GBT
ICS
11.080.01
CCS
C47
Status
Upcoming
Issue Date
2025-12-02
Implementation
2027-07-01
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 provides guidance on dosimetric procedures for the development, validation, and routine control of radiation sterilization processes for healthcare products. It is applied by medical device manufacturers and sterilization facilities to ensure that the correct radiation dose is delivered to products such as surgical instruments, implants, and wound dressings. The standard is used in compliance with regulatory requirements for sterilization validation and routine production monitoring.

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.