NF EN ISO 11138-2

NF EN ISO 11138-2

August 2009
Standard Cancelled

Sterilization of health care products - Biological indicators - Part 2 : biological indicators for ethylene oxide sterilization processes

ISO 11138-2:2006 provides specific 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.

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Main informations

Collections

National standards and national normative documents

Publication date

August 2009

Number of pages

15 p.

Reference

NF EN ISO 11138-2

ICS Codes

11.080.01   Sterilization and disinfection in general

Classification index

S98-004-2

Print number

1 - 18/08/2009

International kinship

ISO 11138-2:2006

European kinship

EN ISO 11138-2:2009
Sumary
Sterilization of health care products - Biological indicators - Part 2 : biological indicators for ethylene oxide sterilization processes

ISO 11138-2:2006 provides specific 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.

Replaced standards (1)
NF EN ISO 11138-2
October 2006
Standard Cancelled
Sterilization of health care products - Biological indicators - Part 2 : biological indicators for ethylene oxide sterilization processes

<p>ISO 11138-2:2006 provides specific 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.</p>

Standard replaced by (1)
NF EN ISO 11138-2
June 2017
Standard Current
Sterilization of health care products - Biological indicators - Part 2 : biological indicators for ethylene oxide sterilization processes

<p>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.</p> <p>NOTE 1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135 and ISO 14937.</p> <p>NOTE 2 National or regional regulations can provide requirements for work place safety.</p>

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