# ISO/TR 13409:1996 — Withdrawn and superseded ISO standards For ISO/TR 13409:1996, item title is Sterilization of health care products — Radiation sterilization — Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches; status code is 9599; successor is ISO/TS 13409:2002; withdrawn / published date is 1996-12-19, recorded from its source on 2026-08-05. - **Identifier:** ISO/TR 13409:1996 _(verified: appears in the quote below)_ - **Item title:** Sterilization of health care products — Radiation sterilization — Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches _(verified: appears in the quote below)_ - **Status code:** 9599 _(verified: appears in the quote below)_ - **Successor:** ISO/TS 13409:2002 - **Withdrawn / published date:** 1996-12-19 _(verified: appears in the quote below)_ ## What the source says > 21926,TR,,ISO/TR 13409:1996,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,1996-12-19,1,['11.080.01'],ISO/TC 198,9599,,[36708],"['en','fr']",19,"
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. ## Source - https://isopublicstorageprod.blob.core.windows.net/opendata/_latest/iso_deliverables_metadata/csv/iso_deliverables_metadata.csv Last verified: 2026-08-05. Review by: 2027-02-01. Part of [Withdrawn and superseded ISO standards](https://referencesource.org/iso-standard-supersessions/).