ISO 11737-2:1998 PDF
Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the validation of a sterilization process
Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the validation of a sterilization process
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Количество страниц:
- 13
- Дата публикации:
- 9 июля 1998 г.
- Издание:
- ISO IS 11737 edition 1 version 1
- ICS:
- 07.100.10
La présente partie de l'ISO 11737 spécifie les critères généraux pour les essais de stérilité des dispositifs médicaux qui ont été soumis à un traitement avec l'agent de stérilisation correspondant à une fraction du procédé de stérilisation spécifié. Les essais décrits sont destinés à être pratiqués lors de la validation d'un procédé de stérilisation.La présente partie de l'ISO ne s'applique pas a) aux essais de stérilité pour une mise à disposition de routine d'un produit après un procédé de stérilisation;b) à l'essai de stérilité de la pharmacopée;NOTE 1 Les essais a) et b) ne font pas partie des prescriptions des normes ISO 11134, ISO 11135 ou ISO 11137.c) à la culture d'indicateurs biologiques, y compris les produits inoculés.NOTE2 Des méthodes de culture d'indicateurs biologiques sont décrites dans l'ISO 11138.
Технические детали
- Технический комитет
- ISO/TC 198 - Sterilization of health care products
- SKU
- ISO 11737-2:1998
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