Sterilization of health care products. Moist heat - Guidance on the application of ISO 17665-1 Ingestion-build-78747 d) where production is stable

d) where production is stable (under statistical control) and the quality characteristic x is distributed according to a normal distribution or a close approximation to the normal distribution

ensuring the prevention of oxidation

marking and information to be supplied for protective gloves against the mechanical risks of abrasion

New Annexes H and I have been added and the test procedure for heat leakage has been revised

Sterilization of health care products. Moist heat - Guidance on the application of ISO 17665-1 Ingestion-build-78747 d) where production is stable1 Scope This Technical Specification provides general guidance on the development, validation and routine control of moist heat sterilization processes and is intended to explain the requirements set forth in ISO 17665 1. The guidance given in this Technical Specification is provided to promote good practice related to moist heat sterilization processes and to assist those developing and validating a moist heat sterilization process according to ISO