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Glavni meni

ISO 11135-1:2007

Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
27. 4. 2007.
95.99   Povučen   7. 7. 2014.

Опште информације

95.99     7. 7. 2014.

ISO

ISO/TC 198

Međunarodni standard

11.080.01  

engleski   francuski  

Kupovina

Povučen

Jezik na kome želite da primite dokument.

Apstrakt

ISO 11135-1:2007 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices.
Sterilization processes validated and controlled in accordance with the requirements of ISO 11135-1:2007 are not assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld Jacob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

Životni ciklus

PRETHODNO

POVUČEN
ISO 11135:1994

POVUČEN
ISO 11135:1994/Cor 1:1994

TRENUTNO

POVUČEN
ISO 11135-1:2007
95.99 Povučen
7. 7. 2014.

REVIDIRAN OD

OBJAVLJEN
ISO 11135:2014

Nacionalna preuzimanja

Sterilizacija proizvoda za medicinsku upotrebu - Etilen-oksid - Deo 1: Zahtevi za razvoj, validaciju i rutinsku kontrolu procesa sterilizacije za medicinska sredstva

95.99   Povučen