Historical
ISO 13683:1997
Sterilization of health care products -- Requirements for validation and routine control of moist heat sterilization in health care facilities
Inclusions
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.
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.
Exclusions
This International Standard does not describe a quality assurance system for the control of all stages of production.
Except for general requirements, this International Standard does not provide detailed requirements for all equipment used within a sterilization system (e.g. washing equipment).
This International Standard does not address sterilization processes that employ a chemical/steam mixture as the sterilant.
This International Standard does not apply to industrial moist heat sterilization, which is addressed by ISO 11134.
Content Provider
International Organization for Standardization [iso]
