NF EN ISO 11140-4

NF EN ISO 11140-4

June 2007
Standard Current

Sterilization of health care products - Chemical indicators - Part 4 : class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration

ISO 11140-4:2007 specifies the performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick-type test for steam sterilizers for wrapped health care goods (instruments, etc. and porous loads). An indicator complying with ISO 11140-4:2007 incorporates a specified material which is used as a test load. This test load may, or may not, be re-usable. ISO 11140-4:2007 does not specify requirements for the test load, but specifies the performance of the indicator in combination with the test load with which it is intended to be used. The indicator specified in ISO 11140-4:2007 is intended to identify poor steam penetration but does not necessarily indicate the cause of this poor steam penetration. This part of ISO 11140-4:2007 does not include test methods to establish the suitability of these indicators for use in sterilizers in which the air removal stage does not include evacuation below atmospheric pressure.

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Main informations

Collections

National standards and national normative documents

Publication date

June 2007

Number of pages

48 p.

Reference

NF EN ISO 11140-4

ICS Codes

11.080.10   Sterilizing equipment
11.080.20   Disinfectants and antiseptics

Classification index

S98-001-4

Print number

1 - 29/05/2007

International kinship

ISO 11140-4:2007

European kinship

EN ISO 11140-4:2007
Sumary
Sterilization of health care products - Chemical indicators - Part 4 : class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration

ISO 11140-4:2007 specifies the performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick-type test for steam sterilizers for wrapped health care goods (instruments, etc. and porous loads).

An indicator complying with ISO 11140-4:2007 incorporates a specified material which is used as a test load. This test load may, or may not, be re-usable. ISO 11140-4:2007 does not specify requirements for the test load, but specifies the performance of the indicator in combination with the test load with which it is intended to be used. The indicator specified in ISO 11140-4:2007 is intended to identify poor steam penetration but does not necessarily indicate the cause of this poor steam penetration.

This part of ISO 11140-4:2007 does not include test methods to establish the suitability of these indicators for use in sterilizers in which the air removal stage does not include evacuation below atmospheric pressure.

Replaced standards (1)
NF EN 867-4
February 2001
Standard Cancelled
Non-biological systems for use in sterilizers - Part 4 : specification for indicators as an alternative to the Bowie and Dick test for the detection of steam penetration

Le présent document spécifie les exigences de performances qui s'appliquent à un indicateur de Classe B servant d'alternative à l'essai de Bowie-Dick pour les stérilisateurs à la vapeur d'eau utilisés pour les objets enveloppés (instruments, etc.).

Table of contents
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  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Exigences générales
    3
  • 5 Format du système indicateur
    4
  • 6 Exigences de performance
    5
  • 7 Emballage et étiquetage
    7
  • 8 Assurance qualité
    8
  • Annexe A (normative) Détermination de la résistance de l'indicateur pendant et après la stérilisation à la vapeur
    9
  • Annexe B (normative) Cycles d'essai normalisés
    11
  • Annexe C (normative) Estimation de la différence visuelle entre les couleurs du substrat et du système indicateur modifié ou non en déterminant la densité optique relative par réflexion
    17
  • Annexe D (normative) Détermination du changement de couleur uniforme d'un indicateur soumis à de la vapeur saturée
    21
  • Annexe E (normative) Détermination de l'équivalence des indicateurs utilisés comme alternative à l'essai de Bowie et Dick
    22
  • Annexe F (normative) Détermination de la reproductibilité des conditions d'échec créées dans un paquet d'essai standard par les méthodes d'injection d'air, de fuite d'air ou de rétention d'air
    24
  • Annexe G (normative) Détermination du changement de couleur de l'indicateur lors d'une exposition à la chaleur sèche
    29
  • Annexe H (normative) Détermination de la durée de conservation du produit
    30
  • Annexe I (normative) Vieillissement accéléré des échantillons d'essai
    31
  • Annexe J (normative) Appareil d'exposition à la vapeur et vapeur utilisée dans les essais d'exposition à la vapeur
    32
  • Annexe K (normative) Paquet d'essai standard
    35
  • Annexe L (normative) Système d'injection d'air
    36
  • Bibliographie
    38
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