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Glavni meni

ISO 11138-2:2017

Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
3. 3. 2017.

Опште информације

90.93     9. 12. 2022.

ISO

ISO/TC 198

Međunarodni standard

11.080.01  

engleski   francuski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

ISO 11138-2:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C.
NOTE 1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135 and ISO 14937.
NOTE 2 National or regional regulations can provide requirements for work place safety.

Životni ciklus

PRETHODNO

POVUČEN
ISO 11138-2:2006

TRENUTNO

OBJAVLJEN
ISO 11138-2:2017
90.93 Odluka o potvrđivanju standarda
9. 12. 2022.

Nacionalna preuzimanja

Sterilizacija proizvoda za zaštitu zdravlja – Biološki indikatori – Deo 2: Biološki indikatori za postupke sterilizacije etilen-oksidom

60.60   Standard objavljen