NF EN ISO 11737-1

NF EN ISO 11737-1

January 2018
Standard Current

Sterilization of health care products - Microbiological methods - Part 1 : determination of a population of microorganisms on products

ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package. NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data. NOTE 2 See Annex A for guidance on Clauses 1 to 9. ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442‑3, ICH Q5A(R1) and ISO 13022. ISO 11737-1:2018 does not apply to the microbiological monitoring of the environment in which health care products are manufactured.

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Main informations

Collections

National standards and national normative documents

Publication date

January 2018

Number of pages

66 p.

Reference

NF EN ISO 11737-1

ICS Codes

07.100.10   Medical microbiology
11.080.01   Sterilization and disinfection in general

Classification index

S98-118-1

Print number

2 - 01/11/2021

International kinship

ISO 11737-1:2018

European kinship

EN ISO 11737-1:2018
Sumary
Sterilization of health care products - Microbiological methods - Part 1 : determination of a population of microorganisms on products

ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package.

NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data.

NOTE 2 See Annex A for guidance on Clauses 1 to 9.

ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.

NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442‑3, ICH Q5A(R1) and ISO 13022.

ISO 11737-1:2018 does not apply to the microbiological monitoring of the environment in which health care products are manufactured.

Replaced standards (1)
NF EN ISO 11737-1
July 2006
Standard Cancelled
Sterilization of medical devices - Microbiological methods - Part 1 : determination of a population of microorganisms on products

<p>ISO 11737-1:2006 specifies requirements and provides guidance for the enumeration and microbial characterization of the population of viable micro-organisms on or in a medical device, component, raw material or package.</p>

Table of contents
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  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences générales
  • 5 Sélection des produits
  • 6 Méthodes de détermination et de caractérisation microbienne de la biocharge
  • 7 Validation de la méthode de détermination de la biocharge
  • 8 Détermination de routine de la biocharge et interprétation des données
  • 9 Entretien de la méthode de détermination de la biocharge
  • Annexe A (informative) Recommandations relatives à la détermination d'une population de microorganismes sur des produits
  • Annexe B (informative) Recommandations relatives aux méthodes de détermination de la biocharge
  • Annexe C (informative) Validation de l'efficacité de la récupération de la biocharge
  • Annexe D (informative) Répartition type des responsabilités
  • Annexe ZA (informative) Relation entre la présente Norme européenne et les exigences essentielles de la Directive européenne 90/385/CEE relative aux dispositifs médicaux implantables actifs
  • Annexe ZB (informative) Relation entre la présente Norme européenne et les exigences essentielles de la Directive européenne 93/42/CEE relative aux dispositifs médicaux
  • Annexe ZC (informative) Relation entre la présente Norme européenne et les exigences essentielles de la Directive européenne 98/79/CE relative aux dispositifs médicaux de diagnosticin vitro
  • Bibliographie
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