NF EN ISO 11737-1

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

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.

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National standards and national normative documents

Publication date

July 2006

Number of pages

51 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 - 01/08/2009

International kinship

ISO 11737-1:2006

European kinship

EN ISO 11737-1:2006
Sumary
Sterilization of medical devices - Microbiological methods - Part 1 : determination of a population of microorganisms on products

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.

Replaced standards (3)
NF EN 1174-1
April 1996
Standard Cancelled
Sterilization of medical devices. Estimation of the population of micro-organisms on product. Part 1 : requirements.

Le présent document spécifie les critères généraux devant être appliqués pour estimer la population de micro-organismes viables sur un dispositif médical ou un composant, une matière première ou un emballage. Cette estimation concerne le dénombrement et la caractérisation de la population mais ne s'applique pas à la contamination virale, ni à l'environnement de fabrication des dispositifs médicaux.

NF EN 1174-2
January 1997
Standard Cancelled
Sterilization of medical devices. Estimation of the population of micro-organisms on product. Part 2 : guidance.

Le présent document constitue un guide pour la mise en oeuvre de la norme européenne EN 1174-1. Son objectif est d'en permettre une meilleure compréhension tout en facilitant l'application de ses exigences. Il ne prétend pas être exhaustif mais il souligne certains aspects importants qui devraient faire l'objet d'une attention particulière.

NF EN 1174-3
January 1997
Standard Cancelled
Sterilization of medical devices. Estimation of the population of micro-organisms on product. Part 3 : guide to the methods for validation of microbiological techniques.

Le présent document décrit les approches pouvant être suivies lors de la validation des techniques d'estimation de la charge microbienne.

Standard replaced by (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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