GB 16383-2014 Active National standards force_standard

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

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

Publish Date: 2014-12-22 Implement Date: 2015-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB 16383-2014

Standard Type: National standards

Standard Status: Active

is_force_gb: yes

CCS Name: Health

ICS Name: Disinfection and sterilization

Publish Date: 2014-12-22

Implement Date: 2015-07-01

Pages: 7 pages

Scope

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

Development Information

Word Count: 10 Thousand words Pages: 7 pages

Replace the following standards

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

Referenced Standards

中华人民共和国药典(二部)(2010年版) GB 18280-2000 Sterilization of health care products—Requirement for validation and routine control—Radiation sterilization GB 18280.1-2015 Sterilization of health care products—Radiation—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices GB 18280.2-2015 Sterilization of health care products—Radiation—Part 2:Establishing the sterilization dose GB/T 18280.3-2015 Sterilization of health care products—Radiation—Part 3:Guidance on dosimetric aspects GB 18871-2002 Basic standards for protection against ionizing radiation and for the safety of radiation sources JJG 591-1989 Verification Regulation of γ-Ray Radiation Source (for Radiation processing ) GB/T 18280.2-2025 Sterilization of health care products—Radiation—Part 2:Establishing the sterilization dose GB 18280.1-2025 Sterilization of health care products—Radiation—Part 1:Requirements for the development,validation and routine control of a sterilization process for medical devices GB/T 18280.3-2025 Sterilization of health care products—Radiation—Part 3:Guidance on dosimetric aspects of development,validation and routine control

Related Standards

GB/T 8600-1988 Replaced

GB/T 8600-1988 Inspecting method for sterilizing effect of automated autoclave sterilizer

Publish Date: 1988-01-12

GB 8599-1988 Replaced

GB 8599-1988 Specifications for automated autoclave sterilizer

Publish Date: 1988-01-13

GB 15981-1995 Replaced

GB 15981-1995 Evaluating method and standard for the efficacy of disinfection and sterilization

Publish Date: 1996-01-23

GB 15982-1995 Replaced

GB 15982-1995 Hygienic standard for disinfection in hospitals

Publish Date: 1996-01-23

GB 16383-1996 Replaced

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

Publish Date: 1996-05-23

GB 18279-2000 Replaced

GB 18279-2000 Medical devices—Validation and routine control of ethylene oxide sterilization

Publish Date: 2000-12-13