NF EN ISO 18472

NF EN ISO 18472

September 2018
Standard Current

Sterilization of health care products - Biological and chemical indicators - Test equipment

This document specifies the requirements for test equipment to be used to:— test biological indicators for steam, ethylene oxide gas and dry heat sterilization processes for conformity to the requirements given in ISO 11138 series;— test chemical indicators for steam, ethylene oxide gas, dry heat and vaporized hydrogen peroxide sterilization processes for conformity to the requirements given in ISO 11140‑1:2014.This document also provides informative methods useful in characterizing the performance of biological and chemical indicators for intended use and for routine quality control testing.This document does not specify requirements for test equipment for processes specifically for testing chemical and biological indicators intended to monitor isolator and room biodecontamination processes at atmospheric pressure.ISO 11138‑2:2017, ISO 11138‑3:2017, ISO 11138‑4:2017 and ISO 11140‑1:2014 require the use of resistometers specified in this document, and these resistometers are used in conjunction with the test methods specified in the appropriate parts of ISO 11138 series and ISO 11140 series.Resistometers for low temperature steam and formaldehyde indicators are not included in this document. Test methods using laboratory apparatus for low temperature steam and formaldehyde are included in ISO 11138‑5:2017.Test equipment for testing Type 2 (e.g. Bowie Dick) chemical indicators are specified in ISO 11140‑3:2007, ISO 11140‑4:2007, and ISO 11140‑5:2007.

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Main informations

Collections

National standards and national normative documents

Publication date

September 2018

Number of pages

41 p.

Reference

NF EN ISO 18472

ICS Codes

11.080.01   Sterilization and disinfection in general

Classification index

S98-005

Print number

1

International kinship

European kinship

EN ISO 18472:2018
Sumary
Sterilization of health care products - Biological and chemical indicators - Test equipment

This document specifies the requirements for test equipment to be used to:

— test biological indicators for steam, ethylene oxide gas and dry heat sterilization processes for conformity to the requirements given in ISO 11138 series;

— test chemical indicators for steam, ethylene oxide gas, dry heat and vaporized hydrogen peroxide sterilization processes for conformity to the requirements given in ISO 11140‑1:2014.

This document also provides informative methods useful in characterizing the performance of biological and chemical indicators for intended use and for routine quality control testing.

This document does not specify requirements for test equipment for processes specifically for testing chemical and biological indicators intended to monitor isolator and room biodecontamination processes at atmospheric pressure.

ISO 11138‑2:2017, ISO 11138‑3:2017, ISO 11138‑4:2017 and ISO 11140‑1:2014 require the use of resistometers specified in this document, and these resistometers are used in conjunction with the test methods specified in the appropriate parts of ISO 11138 series and ISO 11140 series.

Resistometers for low temperature steam and formaldehyde indicators are not included in this document. Test methods using laboratory apparatus for low temperature steam and formaldehyde are included in ISO 11138‑5:2017.

Test equipment for testing Type 2 (e.g. Bowie Dick) chemical indicators are specified in ISO 11140‑3:2007, ISO 11140‑4:2007, and ISO 11140‑5:2007.

Replaced standards (1)
NF EN ISO 18472
August 2006
Standard Cancelled
Sterilization of health care products - Biological and chemical indicators - Test equipment

Le présent document spécifie les exigences relatives aux équipements d'essai à utiliser pour s'assurer de la conformité des indicateurs chimiques et biologiques pour les procédés à la vapeur, à l'oxyde d'éthylène, à la chaleur sèche et au peroxyde d'hydrogène gazeux avec les exigences indiquées dans l'ISO 11140, partie 1 relative aux indicateurs chimiques et la série de normes ISO 11138 relatives aux indicateurs biologiques. Il fournit également des méthodes informatives permettant de qualifier les performances des indicateurs biologiques et chimiques pour leur usage prévu et pour des contrôles de la qualité de routine.

Table of contents
  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences de performance pour les résistomètres
  • 5 Étalonnage
  • Annexe A (informative) Caractérisation complémentaire des performances - Vapeur d'eau
  • Annexe B (informative) Caractérisation complémentaire des performances - Oxyde d'éthylène gazeux
  • Annexe C (informative) Caractérisation complémentaire des performances - Chaleur sèche
  • Annexe D (informative) Documentation du résistomètre et dérivations
  • Bibliographie
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