ISO/TR 13409:1996Withdrawn

Sterilization of health care products — Radiation sterilization — Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches

Stérilisation des produits de santé — Stérilisation par irradiation — Justification d'une dose de stérilisation de 25 kGy pour des lots de fabrication de faible volume ou intermittents

Abstract / scope

Describes a method of substantiating the suitability of 25 kGy as a sterilization dose for radiation sterilization of health care products with an average bioburden of less than 1 000 colony forming units (cfu), that are manufactured in small quantities.

Life cycle

Replaced by

ISO/TS 13409:2002WithdrawnSterilization of health care products — Radiation sterilization — Substantiation of 25 kGy as a sterilization dose for small or infrequent production batchesTechnical Specification · Published 19 Sep 2002 · ISO/TC 198