NF EN ISO 15882

NF EN ISO 15882

February 2004
Standard Cancelled

Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results

ISO 15882:2003 provides guidance for the selection, use and interpretation of results of chemical indicators used in process definition, validation, and routine monitoring and control of sterilization processes. ISO 15882:2003 is applicable to chemical indicators for which International Standards exist (see ISO 11140 series). ISO 15882:2003 is not applicable to those processes that rely on physical removal of microorganisms, e.g. filtration. ISO 15882:2003 is not intended to apply to combination processes, for example, washer-disinfectors or flushing and steaming of pipelines.

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Main informations

Collections

National standards and national normative documents

Publication date

February 2004

Number of pages

26 p.

Reference

NF EN ISO 15882

ICS Codes

11.080.10   Sterilizing equipment

Classification index

S98-119

Print number

1 - 04/05/2004

International kinship

ISO 15882:2003

European kinship

EN ISO 15882:2003
Sumary
Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results

ISO 15882:2003 provides guidance for the selection, use and interpretation of results of chemical indicators used in process definition, validation, and routine monitoring and control of sterilization processes. ISO 15882:2003 is applicable to chemical indicators for which International Standards exist (see ISO 11140 series).

ISO 15882:2003 is not applicable to those processes that rely on physical removal of microorganisms, e.g. filtration.

ISO 15882:2003 is not intended to apply to combination processes, for example, washer-disinfectors or flushing and steaming of pipelines.

Standard replaced by (1)
NF EN ISO 15882
April 2010
Standard Current
Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results

<p>ISO 15882:2008 provides guidance for the selection, use and interpretation of results of chemical indicators used in process definition, validation and routine monitoring and overall control of sterilization processes.</p> <p>ISO 15882:2008 applies to indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor one or more of the variables required for a sterilization process. These chemical indicators are not dependent for their action on the presence or absence of a living organism.</p>

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
    1
  • 4 Considérations générales
    2
  • 5 Classes d'indicateurs chimiques
    4
  • 5.1 Généralités
    4
  • 5.2 Classe 1: Indicateurs de procédé
    4
  • 5.3 Classe 2: Indicateurs pour essais spécifiques
    4
  • 5.4 Classe 3: Indicateurs de paramètres individuels
    5
  • 5.5 Classe 4: Indicateurs multiparamétriques
    6
  • 5.6 Classe 5: Indicateurs intégrateurs
    7
  • 5.7 Classe 6: Indicateurs émulateurs
    9
  • 6 Sélection des indicateurs chimiques
    10
  • 7 Utilisation des indicateurs chimiques
    10
  • 7.1 Indicateurs chimiques externes
    10
  • 7.2 Indicateurs chimiques internes
    11
  • 7.3 Indicateurs utilisés lors de modes opératoires d'essai spécifiques
    11
  • 7.4 Indicateurs utilisés avec les dispositifs d'épreuve de procédé
    11
  • 8 Interprétation des indicateurs chimiques
    12
  • 8.1 Généralités
    12
  • 8.2 Réponses des indicateurs chimiques
    12
  • 8.3 Indicateurs chimiques indiquant un résultat négatif
    12
  • 9 Indicateurs chimiques dans les procédures d'assurance de la stérilité
    12
  • 9.1 Généralités
    12
  • 9.2 Archivage des données
    14
  • 10 Étiquetage des indicateurs chimiques
    14
  • 11 Formation du personnel
    14
  • 12 Stockage et manipulation
    14
  • Annexe A (informative) Généralités sur l'essai de Bowie-Dick
    15
  • Bibliographie
    18
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