NF EN ISO 11140-1

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.

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Main informations

Collections

National standards and national normative documents

Publication date

August 2009

Number of pages

42 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 - 13/08/2009

International kinship

ISO 11140-1:2005

European kinship

EN ISO 11140-1:2009
Sumary
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.

Replaced standards (1)
NF EN ISO 11140-1
December 2005
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.

Standard replaced by (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.

Table of contents
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Classification
    3
  • 5 Exigences générales
    4
  • 6 Exigences de performance
    6
  • 7 Méthodes d'essai
    7
  • 8 Exigences supplémentaires pour les indicateurs de passage (classe 1)
    10
  • 9 Exigences supplémentaires pour les indicateurs à paramètre unique (classe 3)
    13
  • 10 Exigences supplémentaires pour les indicateurs à paramètres multiples (classe 4)
    14
  • 11 Exigences supplémentaires pour les indicateurs-intégrateurs (classe 5) à la vapeur d'eau
    14
  • 12 Exigences supplémentaires pour les indicateurs-intégrateurs (classe 5) pour la chaleur sèche
    15
  • 13 Exigences supplémentaires pour les indicateurs-intégrateurs (classe 5) pour l'oxyde d'éthylène
    16
  • 14 Exigences supplémentaires pour indicateurs-émulateurs (classe 6)
    17
  • Annexe A (informative) Méthode de démonstration de la durée de conservation du produit
    18
  • Annexe B (informative) Exemples d'essais réalisés sur des indicateurs
    19
  • Annexe C (informative) Justification des exigences relatives aux indicateurs-intégrateurs et lien avec les exigences relatives aux indicateurs biologiques spécifiées dans l'ISO 11138 et l'inactivation microbienne
    21
  • Annexe D (informative) Justification des méthodes d'essai en phase liquide et en phase gazeuse pour les indicateurs à la vapeur de formaldéhyde
    28
  • Annexe E (informative) Relations entre les composants d'un indicateur
    29
  • Bibliographie
    30
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