GB 18278-2000
Sterilization of health care products--Requirements for validation and routine control--Industrial moist heat sterilization (English Version)
- Standard No.
- GB 18278-2000
- 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
- 2017-01
- Replace By
- GB 18278.1-2015
- Latest
- GB 18278.1-2015
- Scope
- This standard specifies the setting and confirmation of moist heat sterilization process and the monitoring requirements for routine sterilization. This standard involves all applied moist heat sterilization processes, including saturated steam and air-steam mixed gas, and is applicable to all industrial production plants and workers engaged in moist heat sterilization. Although moist heat sterilization in the non-industrial healthcare sector is not explicitly covered by this standard, the principles outlined are also useful for the most part. Note 1: If the general principles of this standard apply to the sterilization of pharmaceuticals, other technical requirements or management requirements may also apply. This standard does not cover a quality assurance system, which must control all production stages (including sterilization processes).
GB 18278-2000 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
- 2000 GB 18278-2000 Sterilization of health care products--Requirements for validation and routine control--Industrial moist heat sterilization