GB 16383-2014 (English Version) PDF

Standard No.: GB 16383-2014
Language: Chinese, Available in English version
Release Date: 2014
Published By: General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Latest: GB 16383-2014
Replace: GB 16383-1996

Scope: This standard specifies the terms and definitions of radiation sterilization and disinfection of medical and sanitary products, radiation sterilization and disinfection requirements, product radiation treatment requirements, microbial monitoring methods and requirements, release requirements of radiation products and management requirements after radiation. This standard applies to all units that carry out radiation sterilization and disinfection.

GB 16383-2014 Referenced Document

GB 18280 Sterilization of health care products--Requirement for validation and routine control--Radiation sterilization
GB 18871 Basic standards for protection against ionizing radiation and for the safety of radiation sources
JJG 591 Verification Regulation of γ-Ray Radiation Source (for Radiation Processing)

2014 GB 16383-2014 Quality control for radiation sterilization of medical and hygienical products
1996 GB 16383-1996 Quality control standards for radiation sterilization of medical and hygienical products