NF EN ISO 11138-3

NF EN ISO 11138-3

August 2009
Standard Cancelled

Sterilization of health care products - Biological indicators - Part 3 : biological indicators for moist heat sterilization processes

ISO 11138-3:2006 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 moist heat as the sterilizing agent.Moist heat as the sterilizing agent is defined in ISO 11138-3:2006 as dry saturated steam. While air-steam mixtures may be used in moist heat sterilization processes, the methods and performance requirements of this part of ISO 11138 might not be applicable for biological indicators used in such processes.

View the extract
Main informations

Collections

National standards and national normative documents

Publication date

August 2009

Number of pages

18 p.

Reference

NF EN ISO 11138-3

ICS Codes

11.080.01   Sterilization and disinfection in general

Classification index

S98-004-3

Print number

1 - 18/08/2009

International kinship

European kinship

EN ISO 11138-3:2009
Sumary
Sterilization of health care products - Biological indicators - Part 3 : biological indicators for moist heat sterilization processes

ISO 11138-3:2006 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 moist heat as the sterilizing agent.

Moist heat as the sterilizing agent is defined in ISO 11138-3:2006 as dry saturated steam. While air-steam mixtures may be used in moist heat sterilization processes, the methods and performance requirements of this part of ISO 11138 might not be applicable for biological indicators used in such processes.

Standard replaced by (1)
NF EN ISO 11138-3
June 2017
Standard Current
Sterilization of health care products - Biological indicators - Part 3 : biological indicators for moist heat sterilization processes

ISO 11138-3:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent. NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by the ISO 17665 series. NOTE 2 National or regional regulations can provide requirements for work place safety.

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 par chaleur humide
  • Annexe B (normative) Calcul de la valeur dezet coefficient de corrélation, r2
  • Annexe ZA (informative) Relation entre la présente norme européenne et les exigences essentielles de la Directive CE 93/42/CEE
  • Bibliographie
Need to identify, monitor and decipher standards?

COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.

Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!

Request your free, no-obligation live demo

I discover COBAZ