NF EN ISO 11140-1

NF EN ISO 11140-1

February 2015
Standard Current

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

ISO 11140-1:2014 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the process parameter(s) specified for a sterilization process. They are not dependent for their action on the presence or absence of a living organism.

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Main informations

Collections

National standards and national normative documents

Publication date

February 2015

Number of pages

41 p.

Reference

NF EN ISO 11140-1

ICS Codes

11.080.01   Sterilization and disinfection in general

Classification index

S98-001-1

Print number

1

International kinship

ISO 11140-1:2014

European kinship

EN ISO 11140-1:2014
Sumary
Sterilization of health care products - Chemical indicators - Part 1 : general requirements

ISO 11140-1:2014 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the process parameter(s) specified for a sterilization process. They are not dependent for their action on the presence or absence of a living organism.

Replaced standards (1)
NF EN ISO 11140-1
August 2009
Standard Cancelled
Sterilization of health care products - Chemical indicators - Part 1 : general requirements

ISO 11140-1:2005 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the variables required for a sterilization process. They are not dependent for their action on the presence or absence of a living organism. The requirements and test methods of ISO 11140-1:2005 apply to all indicators specified in subsequent parts of ISO 11140, unless the requirement is modified or added to by a subsequent part, in which case the requirement of that particular part will apply.

Table of contents
  • Introduction
    vi
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Classification
    4
  • 5 Exigences générales
    5
  • 6 Exigences de performance
    8
  • 7 Méthodes d'essai
    9
  • 8 Exigences supplémentaires pour les indicateurs d'exposition (Classe 1)
    12
  • 9 Exigences supplémentaires pour les indicateurs à paramètre critique unique (Classe 3)
    16
  • 10 Exigences supplémentaires pour les indicateurs à paramètres critiques multiples (Classe 4)
    16
  • 11 Exigences supplémentaires pour les indicateurs-intégrateurs (Classe 5) pour la vapeur d'eau
    17
  • 12 Exigences supplémentaires pour les indicateurs-intégrateurs (Classe 5) pour l'oxyde d'éthylène
    18
  • 13 Exigences supplémentaires pour les indicateurs-émulateurs (Classe 6)
    19
  • Annexe A (normative) Méthode de démonstration de la durée de conservation du produit
    20
  • Annexe B (informative) Exemples d'essais réalisés sur les indicateurs
    21
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