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
Sterilization of health care products — Radiation sterilization — Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
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Sterilization of health care products — Radiation sterilization — Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
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.
| Edition | 1996 |
|---|---|
| Published Date | 1996 |
| Published By | International Standardization Organisation/Technical Reference |
| Page Count | 19 |