GB/T 20367-2006
Sterilization of health care products. Requirement for validation and routine control of moist heat sterilization in health care facilities (English Version)
- Standard No.
- GB/T 20367-2006
- Language
- Chinese, Available in English version
- Release Date
- 2006
- Published By
- General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
- Status
- 2017-01
- Replace By
- GB 18278.1-2015
- Latest
- GB 18278.1-2015
- Scope
- This standard specifies the requirements for process development, validation and routine sterilization control of moist heat sterilization by medical care institutions or institutions undertaken by medical care organizations. This standard covers all moist heat sterilization processes in healthcare facilities where the sterilizing agent can be either steam, a mixture of steam and air, or pressurized water. This standard does not cover a quality assurance system that controls all stages of production. In addition to general requirements, this standard does not impose specific requirements for all equipment used in sterilization systems (for example: cleaning equipment). This standard does not involve various sterilization processes that use chemicals mixed with steam as sterilization factors. This standard does not apply to the industrial moist heat sterilization involved in GB 18278.
GB/T 20367-2006 Referenced Document
- GB 18281.1-2000 Sterilization of health care products--Biological indicators--Part 1: General
- GB 18281.3-2000 Sterilization of health care products--Biological indicators--Part 3: Biological indicators for moist heat sterilization
- GB 4793.1-1995 Safety requirements for electrical equipment for measurement, control, and laboratory use. Part 1: General requirements
- GB/T 19001-2000 Quality management systems-Requirements
GB/T 20367-2006 history
- 2017 GB 18278.1-2015 Damp heat for sterilization of healthcare products - Part 1: Requirements for development, validation and routine control of sterilization processes for medical devices
- 2006 GB/T 20367-2006 Sterilization of health care products. Requirement for validation and routine control of moist heat sterilization in health care facilities
GB/T 20367-2006 Sterilization of health care products. Requirement for validation and routine control of moist heat sterilization in health care facilities was changed to GB 18278.1-2015 Damp heat for sterilization of healthcare products - Part 1: Requirements for development, validation and routine control of sterilization processes for medical devices.
