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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Main informations

Collections

National standards and national normative documents

Publication date

March 2004

Number of pages

22 p.

Reference

NF EN ISO 14698-2

ICS Codes

13.040.35 Cleanrooms and associated controlled environments

Classification index

X44-111

Print number

2 - 01/06/2006

International kinship

ISO 14698-2:2003

European kinship

EN ISO 14698-2:2003

Sumary

Cleanrooms and associated controlled environments - Biocontamination control - Part 2 : evaluation and interpretation of biocontamination data

Standard replaced by (1)

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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