NF EN 12297

Biotechnology. Equipment. Guidance on testing procedures for sterilizability.

Le présent document donne des indications sur les procédures d'essai permettant d'évaluer la capacité à la stérilisation de micro-organismes dans des équipements mis en oeuvre dans les procédés biotechnologiques. Le présent document s'applique si l'utilisation prévue de l'équipement met en jeu des micro-organismes dangereux ou potentiellement dangereux. Il ne s'applique pas aux essais de stérilité des milieux avant traitement et des équipements avant leur mise en fonctionnement.

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