NF EN 17141

NF EN 17141

August 2020
Standard Current

Cleanrooms and associated controlled environments - Biocontamination control

Le présent document établit les exigences, les recommandations et la méthodologie relatives à la maîtrise de la contamination microbiologique en environnement propre maîtrisé. Il définit également les exigences à mettre en oeuvre pour établir et démontrer la maîtrise microbiologique en environnement propre maîtrisé. Le présent document se limite à la contamination microbiologique viable et exclut toute considération quant à la contamination par endotoxine, par prion et par virus.Il fournit des recommandations spécifiques concernant certains domaines d'activités courants, comme les secteurs pharmaceutiques/biopharmaceutiques, les dispositifs médicaux, les hôpitaux et l'agro-alimentaire.

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Main informations

Collections

National standards and national normative documents

Publication date

August 2020

Number of pages

65 p.

Reference

NF EN 17141

ICS Codes

13.040.35   Cleanrooms and associated controlled environments

Classification index

X44-113

Print number

1

European kinship

EN 17141:2020
Sumary
Cleanrooms and associated controlled environments - Biocontamination control

Le présent document établit les exigences, les recommandations et la méthodologie relatives à la maîtrise de la contamination microbiologique en environnement propre maîtrisé. Il définit également les exigences à mettre en oeuvre pour établir et démontrer la maîtrise microbiologique en environnement propre maîtrisé. Le présent document se limite à la contamination microbiologique viable et exclut toute considération quant à la contamination par endotoxine, par prion et par virus. Il fournit des recommandations spécifiques concernant certains domaines d'activités courants, comme les secteurs pharmaceutiques/biopharmaceutiques, les dispositifs médicaux, les hôpitaux et l'agro-alimentaire.
Replaced standards (2)
NF EN ISO 14698-1
March 2004
Standard Cancelled
Cleanrooms and associated controlled environments - Biocontamination control - Part 1 : general principles and methods

ISO 14698:2003 establishes the principles and basic methodology of a formal system of biocontamination control (Formal System) for assessing and controlling biocontamination when cleanroom technology is applied for that purpose. It specifies the methods required for monitoring risk zones in a consistent way and for applying control measures appropriate to the degree of risk involved. In zones where risk is low, it can be used for information.

NF EN ISO 14698-2
March 2004
Standard Cancelled
Cleanrooms and associated controlled environments - Biocontamination control - Part 2 : evaluation and interpretation of biocontamination data

ISO 14698-2:2003 gives guidance on methods for the evaluation of microbiological data and the estimation of results obtained from sampling for viable particles in risk zones for biocontamination control. It should be used, where appropriate, in conjunction with ISO 14698-1.

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