SS-EN-ISO-11138-2 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017)

SS-EN-ISO-11138-2 - 2017 EDITION - CURRENT
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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.

To find similar documents by classification:

11.080 (Sterilization and disinfection)

11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)

11.080.20 (Disinfectants and antiseptics Chemicals for industrial and domestic disinfection purposes, see 71.100.35)


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Designation Name

SS-EN ISO 11138-2:2017

Revision Level

2017 EDITION

Status

Current

Publication Date

April 5, 2017

Language(s)

English

Page Count

24

International Equivalent

EN ISO 11138-2:2017(IDT); ISO 11138-2:2017(IDT)