ISO/TR 13409:1996 PDF
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
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Количество страниц:
- 19
- Дата публикации:
- 19 декабря 1996 г.
- Издание:
- ISO TR 13409 edition 1 version 1
- ICS:
- 11.080.01
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.
Технические детали
- Технический комитет
- ISO/TC 198 - Sterilization of health care products
- SKU
- ISO/TR 13409:1996