NF EN ISO 11138-5

NF EN ISO 11138-5

June 2017
Standard Current

Sterilization of health care products - Biological indicators - Part 5 : biological indicators for low-temperature steam and formaldehyde sterilization processes

ISO 11138-5:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent.NOTE 1 Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO 14937.NOTE 2 Requirements for work place safety can be provided by national or regional regulations.

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Main informations

Collections

National standards and national normative documents

Publication date

June 2017

Number of pages

17 p.

Reference

NF EN ISO 11138-5

ICS Codes

11.080.01   Sterilization and disinfection in general

Classification index

S98-004-5

Print number

1

International kinship

ISO 11138-5:2017

European kinship

EN ISO 11138-5:2017
Sumary
Sterilization of health care products - Biological indicators - Part 5 : biological indicators for low-temperature steam and formaldehyde sterilization processes

ISO 11138-5:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent.

NOTE 1 Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO 14937.

NOTE 2 Requirements for work place safety can be provided by national or regional regulations.

Replaced standards (1)
NF EN ISO 11138-5
October 2006
Standard Cancelled
Sterilization of health care products - Biological indicators - Part 5 : biological indicators for low-temperature steam and formaldehyde sterilization processes

ISO 11138-5:2006 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent.

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 la vapeur d'eau et au formaldéhyde à basse température
  • Annexe B (informative) Explication de la méthode d'essai en phase liquide pour les indicateurs biologiques traités à la vapeur d'eau et au formaldéhyde à basse température
  • Bibliographie
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