NF EN ISO 11138-1

NF EN ISO 11138-1

June 2017
Standard Current

Sterilization of health care products - Biological indicators - Part 1 : general requirements

ISO 11138-1:2017 specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.ISO 11138-1:2017 specifies basic and common requirements that are applicable to all parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO 11138. If no specific subsequent part is provided, this document applies.NOTE National or regional regulations can apply.ISO 11138-1:2017 does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This document, however, can contain elements relevant to such microbiological test systems.

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Main informations

Collections

National standards and national normative documents

Publication date

June 2017

Number of pages

49 p.

Reference

NF EN ISO 11138-1

ICS Codes

11.080.01   Sterilization and disinfection in general

Classification index

S98-004-1

Print number

1

International kinship

ISO 11138-1:2017

European kinship

EN ISO 11138-1:2017
Sumary
Sterilization of health care products - Biological indicators - Part 1 : general requirements



ISO 11138-1:2017 specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.

ISO 11138-1:2017 specifies basic and common requirements that are applicable to all parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO 11138. If no specific subsequent part is provided, this document applies.

NOTE National or regional regulations can apply.

ISO 11138-1:2017 does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This document, however, can contain elements relevant to such microbiological test systems.

Replaced standards (1)
NF EN ISO 11138-1
September 2006
Standard Cancelled
Sterilization of health care products - Biological indicators - Part 1 : general requirements

ISO 11138-1:2006 provides general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.ISO 11138-1:2006 specifies basic and common requirements that are applicable to all subsequent parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the subsequent parts of ISO 11138. If no specific subsequent part is provided, this part applies.

Table of contents
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences générales de fabrication
  • 5 Exigences spécifiques relatives à la fabrication
  • 6 Détermination de la population et de la résistance
  • 7 Conditions de culture
  • Annexe A Détermination du nombre d'organismes viables
  • Annexe B Détermination de l'inhibition de la croissance par les matériaux des porte-germes et de l'emballage primaire exposés aux procédés de stérilisation
  • Annexe C Détermination de la valeur de D selon la méthode de la courbe de survie
  • Annexe D Détermination de la valeur de D selon la méthode de la fraction négative
  • Annexe E Caractéristiques de réponse survie-destruction
  • Annexe F Relations entre les composants d'indicateurs biologiques
  • Bibliographie
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