NF EN ISO 11138-4

NF EN ISO 11138-4

June 2017
Standard Current

Sterilization of health care products - Biological indicators - Part 4 : biological indicators for dry heat sterilization processes

ISO 11138-4:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 °C to 180 °C. NOTE 1 Requirements for validation and control of dry heat sterilization processes are provided by ISO 20857. 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

16 p.

Reference

NF EN ISO 11138-4

ICS Codes

11.080.01   Sterilization and disinfection in general

Classification index

S98-004-4

Print number

1

International kinship

ISO 11138-4:2017

European kinship

EN ISO 11138-4:2017
Sumary
Sterilization of health care products - Biological indicators - Part 4 : biological indicators for dry heat sterilization processes

ISO 11138-4:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 °C to 180 °C.

NOTE 1 Requirements for validation and control of dry heat sterilization processes are provided by ISO 20857.

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

Replaced standards (1)
NF EN ISO 11138-4
October 2006
Standard Cancelled
Sterilization of health care products - Biological indicators - Part 4 : biological indicators for dry heat sterilization processes

Le présent document définit des exigences spécifiques pour les organismes d'essai, les suspensions, les porte germes inoculés, les indicateurs biologiques et les méthodes d'essai prévus pour être utilisés dans l'évaluation des performances de procédés de stérilisation utilisant la chaleur sèche comme agent stérilisant. Note : il est rappelé que la stérilisation à la chaleur sèche n'est pas utilisée en France.

Table of contents
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  • 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 par chaleur sèche
  • Annexe B (normative) Calcul de la valeur de z
  • Bibliographie
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