NF EN ISO 11140-3

NF EN ISO 11140-3

November 2007
Standard Cancelled

Sterilization of health care products - Chemical indicators - Part 3 : class 2 indicator systems for use in the Bowie and Dick-type steam penetration test

ISO 11140-3:2007 specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g. instruments and porous materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1. Indicators complying with ISO 11140-3:2007 are intended for use in combination with the standard test pack as described in EN 285. ISO 11140-3:2007 does not consider the performance of the standard test pack, but does specify the performance of the indicators.

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Collections

National standards and national normative documents

Publication date

November 2007

Number of pages

32 p.

Reference

NF EN ISO 11140-3

ICS Codes

11.080.10   Sterilizing equipment
11.080.20   Disinfectants and antiseptics

Classification index

S98-001-3

Print number

1 - 09/11/2007

International kinship

ISO 11140-3:2007

European kinship

EN ISO 11140-3:2007
Sumary
Sterilization of health care products - Chemical indicators - Part 3 : class 2 indicator systems for use in the Bowie and Dick-type steam penetration test

ISO 11140-3:2007 specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g. instruments and porous materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1.

Indicators complying with ISO 11140-3:2007 are intended for use in combination with the standard test pack as described in EN 285. ISO 11140-3:2007 does not consider the performance of the standard test pack, but does specify the performance of the indicators.

Replaced standards (1)
NF EN 867-3
June 1997
Standard Cancelled
Non-biological systems for use in sterilizers. Part 3 : specification for Class B indicators for use in the Bowie and Dick test.

Le présent document spécifie les exigences pour les indicateurs à utiliser dans l'essai de Bowie-Dick pour les stérilisateurs à la vapeur d'eau pour objets emballés. Ces indicateurs correspondent à des indicateurs de la Classe B.

Standard replaced by (1)
NF EN ISO 11140-3
August 2009
Standard Current
Sterilization of health care products - Chemical indicators - Part 3 : class 2 indicator systems for use in the Bowie and Dick-type steam penetration test

<p>ISO 11140-3:2007 specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g. instruments and porous materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1.</p> <p>Indicators complying with ISO 11140-3:2007 are intended for use in combination with the standard test pack as described in EN 285. ISO 11140-3:2007 does not consider the performance of the standard test pack, but does specify the performance of the indicators.</p>

Table of contents
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Exigences générales
    2
  • 5 Format du système indicateur
    2
  • 6 Exigences de performance
    2
  • 7 Emballage et étiquetage
    3
  • 8 Assurance qualité
    4
  • Annexe A (normative) Détermination de la résistance après stérilisation à la vapeur
    5
  • Annexe B (normative) Estimation de la différence visuelle entre les couleurs du substrat et du système indicateur modifié (ou non modifié) en déterminant la densité optique relative par réflexion
    6
  • Annexe C (normative) Détermination du changement de couleur de l'indicateur lors d'une exposition à la chaleur sèche saturée
    10
  • Annexe D (normative) Détermination du changement de couleur de l'indicateur lors d'une exposition à la chaleur sèche
    11
  • Annexe E (normative) Vieillissement accéléré des éprouvettes d'essai
    12
  • Annexe F (normative) Détermination de la migration de l'indicateur sur un emballage d'essai normalisé lors du traitement
    13
  • Annexe G (normative) Détermination de la durée de conservation du produit
    14
  • Annexe H (normative) Appareillage d'exposition à la vapeur
    15
  • Annexe I (normative) Détermination de la sensibilité de l'indicateur en présence d'air
    17
  • Annexe J (normative) Système d'injection d'air
    19
  • Annexe K (normative) Emballage d'essai normalisé
    21
  • Bibliographie
    22
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