NF EN ISO 14698-1

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.

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Main informations

Collections

National standards and national normative documents

Publication date

March 2004

Number of pages

45 p.

Reference

NF EN ISO 14698-1

ICS Codes

13.040.35   Cleanrooms and associated controlled environments

Classification index

X44-110

Print number

1 - 06/05/2004

International kinship

ISO 14698-1:2003

European kinship

EN ISO 14698-1:2003
Sumary
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.

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.

Table of contents
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Principes de maîtrise de la biocontamination
    4
  • 5 Établissement du Système formalisé
    5
  • 6 Expression, interprétation et communication des résultats
    10
  • 7 Vérification du Système formalisé
    11
  • 8 Formation
    11
  • 9 Documentation
    12
  • Annexe A (informative) Conseils relatifs à la détermination de la biocontamination aéroportée (aérobiocontamination)
    13
  • Annexe B (informative) Conseils relatifs à la validation des échantillonneurs d'air
    16
  • Annexe C (informative) Conseils relatifs à la détermination de la biocontamination des surfaces
    20
  • Annexe D (informative) Conseils relatifs à la détermination de la biocontamination des textiles
    22
  • Annexe E (informative) Conseils relatifs à la validation des procédés de blanchisserie
    24
  • Annexe F (informative) Conseils relatifs à la détermination de la biocontamination des liquides
    28
  • Annexe G (informative) Conseils relatifs à la formation
    30
  • Bibliographie
    34
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