scope:

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.

It covers all moist heat proceses, including saturated steam and air-steam mixtures, and applies to all industrial manufacturers and all others who perform contract moist heat sterilization. Although moist heat sterilization in non-industrial health care facilities is not specifically covered in this International Standard, the principles outlined may be useful to the user of moist heat sterilization in these facilities.

NOTE 1 While the general requirements of this International Standard may apply to the sterilization of pharmaceuticals, other technical or regulatory requirements may also apply.

 This International Standard does not cover the quality assurance system which is necessary to control all stages of manufacture, including the sterilization process.