NF EN ISO 15882

NF EN ISO 15882

April 2010
Standard Current

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

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. 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.

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Main informations

Collections

National standards and national normative documents

Publication date

April 2010

Number of pages

43 p.

Reference

NF EN ISO 15882

ICS Codes

11.080.01   Sterilization and disinfection in general

Classification index

S98-119

Print number

1 - 25/03/2010

International kinship

ISO 15882:2008

European kinship

EN ISO 15882:2008
Sumary
Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results

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.

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.

Replaced standards (1)
NF EN ISO 15882
February 2004
Standard Cancelled
Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results

<p>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).</p> <p>ISO 15882:2003 is not applicable to those processes that rely on physical removal of microorganisms, e.g. filtration.</p> <p>ISO 15882:2003 is not intended to apply to combination processes, for example, washer-disinfectors or flushing and steaming of pipelines.</p>

Table of contents
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  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Termes et définitions
    1
  • 3 Considérations générales
    3
  • 4 Classes d'indicateurs chimiques
    5
  • 4.1 Généralités
    5
  • 4.2 Classe 1: Indicateurs de procédé
    5
  • 4.3 Classe 2: Indicateurs à utiliser lors d'essais spécifiques
    6
  • 4.4 Classe 3: Indicateurs à paramètre unique
    7
  • 4.5 Classe 4: Indicateurs à paramètres multiples
    8
  • 4.6 Classe 5: Indicateurs-intégrateurs
    9
  • 4.7 Classe 6: Indicateurs-émulateurs
    10
  • 5 Sélection des indicateurs chimiques
    11
  • 6 Utilisation des indicateurs chimiques
    11
  • 6.1 Indicateurs de procédé de classe 1
    11
  • 6.2 Indicateurs de classe 2
    12
  • 6.3 Indicateurs de classes 3, 4, 5 et 6
    12
  • 6.4 Indicateurs utilisés avec les dispositifs d'épreuve de procédé
    12
  • 7 Interprétation des résultats issus des indicateurs chimiques
    13
  • 7.1 Généralités
    13
  • 7.2 Réponses des indicateurs chimiques
    13
  • 7.3 Indicateurs chimiques indiquant un résultat "négatif"
    13
  • 8 Indicateurs chimiques dans les procédures d'assurance de la stérilité
    14
  • 8.1 Généralités
    14
  • 8.2 Relevés
    15
  • 9 Formation du personnel
    15
  • 10 Stockage et manipulation
    15
  • 11 Étiquetage
    15
  • 11.1 Généralités
    15
  • 11.2 Marquage des indicateurs
    16
  • 11.3 Marquage du procédé
    16
  • 11.4 Marquage du paquet
    16
  • Annexe A (informative) Généralités sur l'essai de Bowie et Dick
    17
  • Annexe B (informative) Explication des termes "paramètre" et "variable"
    20
  • Annexe C (informative) Justification des exigences relatives aux indicateurs intégrateurs et lien avec les exigences relatives aux indicateurs biologiques (IB) spécifiées dans l'ISO 11138 et à l'inactivation microbienne (issues de l'ISO 11140-1)
    21
  • Annexe D (informative) Spécifications relatives à la porosité
    29
  • Annexe E (informative) Schéma indiquant la relation entre les constituants des indicateurs
    31
  • Bibliographie
    32
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