NF EN ISO 11138-2

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

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.

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Main informations

Collections

National standards and national normative documents

Publication date

June 2017

Number of pages

14 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

International kinship

ISO 11138-2:2017

European kinship

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

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.

Replaced standards (1)
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.

Table of contents
  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences générales
  • 5 Organisme d'essai
  • 6 Suspension
  • 7 Porte-germes et emballage primaire
  • 8 Porte-germes inoculés et indicateurs biologiques
  • 9 Population et résistance
  • Annexe A (normative) Méthode pour la détermination de la résistance à la stérilisation à l'oxyde d'éthylène
  • Annexe B (informative) Justification de l'inclusion d'une seconde spécification de valeur de D minimale à la suite du changement de gaz d'essai pour l'évaluation de la résistance, ainsi que de la suppression de l'exigence d'une valeur de D minimale à 30 °C
  • Bibliographie
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