GB/T 18280.3-2015

Active

Sterilization of health care products—Radiation—Part 3:Guidance on dosimetric aspects

医疗保健产品灭菌 辐射 第3部分:剂量测量指南

Standard Type
GBT
ICS
11.080.01
CCS
C47
Status
Active
Issue Date
2015-12-31
Implementation
2018-01-01
Centralized Committee
国家药监局
Issuing Authority
中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会

Application Summary AI generated

This standard provides guidance on dosimetric procedures for validating and monitoring radiation sterilization processes for healthcare products. It is applied in medical device manufacturing and healthcare facilities to ensure that products like surgical instruments, implants, and single-use items receive the correct radiation dose for effective sterilization. The standard is used during process qualification, routine production, and dose auditing to maintain sterility assurance and regulatory compliance.

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.