ISO 13683:1997
Sterilization of health care products - Requirements for validation and routine control of moist heat sterilization in health care facilities
- Standard No.
- ISO 13683:1997
- Release Date
- 1997
- Published By
- International Organization for Standardization (ISO)
- Status
- Latest
- ISO 13683:1997
- Scope
- 1 Inclusions 1.1 This International Standard specifies requirements for the use of moist heat in sterilization process development, validation of the sterilization process, and control of routine sterilization in either a health care facility or a facility contracted by a health care organization. 1.2 This International Standard covers all moist heat processes in health care facilities in which the sterilant is either steam, steam/air mixtures or pressurized water. NOTE — While the general requirements of this International Standard can apply to the sterilization of pharmaceutical products, other technical or regulatory requirements may also apply. 2 Exclusions 2.1 This International Standard does not describe a quality assurance system for the control of all stages of production. NOTE — Attention is drawn to the International Standards for quality systems (ISO 13485 or ISO 13488) which control all stages of production including the sterilization process. It is not a requirement of this International Standard to have a complete quality system during production, but certain elements of such a system are required and these are normatively referenced at appropriate places in the text. 2.2 Except for general requirements, this International Standard does not provide detailed requirements for all equipment used within a sterilization system (e.g. washing equipment). 2.3 This International Standard does not address sterilization processes that employ a chemical/steam mixture as the sterilant. 2.4 This International Standard does not apply to industrial moist heat sterilization, which is addressed by ISO 11134.
ISO 13683:1997 history
- 1997 ISO 13683:1997 Sterilization of health care products - Requirements for validation and routine control of moist heat sterilization in health care facilities
