GB 18280-2000
Sterilization of health care products--Requirement for validation and routine control--Radiation sterilization (English Version)

Standard No.

GB 18280-2000

Language

Chinese, Available in English version

Release Date

2000

Published By

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China

Status

Be replaced 2018-01

Replace By

GB 18280.1-2015

GB 18280.2-2015

GB/T 18280.3-2015

Latest

GB 18280.1-2015

GB 18280.2-2015

GB/T 18280.3-2015

Scope

This standard specifies various requirements for the qualification, process control and routine monitoring of healthcare products in radiation sterilization. It is suitable for continuous and batch type gamma irradiation installations using radionuclides cobalt-60 and cesium-137, as well as irradiation installations using electron beam or X-ray generators. Supplementary references are also provided in the appendices of this standard. Plant design, licensing, operator training and various factors related to radiation safety are outside the scope of this standard. This standard does not include the evaluation of the suitability of the product for its intended use. Biological indicators for validation or process monitoring, or sterility testing for product release are not covered by this standard, as these methods are not recommended for radiation sterilization.

GB 18280-2000 history

• 2015 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
• 2000 GB 18280-2000 Sterilization of health care products--Requirement for validation and routine control--Radiation sterilization

GB 18280-2000 Sterilization of health care products--Requirement for validation and routine control--Radiation sterilization was changed to GB/T 18280.3-2015 Sterilization of health care products.Radiation.Part 3:Guidance on dosimetric aspects.

GB 18280-2000 Sterilization of health care products--Requirement for validation and routine control--Radiation sterilization was changed to GB/T 18280.3-2015 Sterilization of health care products.Radiation.Part 3:Guidance on dosimetric aspects.