STFE0502SD-B

Nom de l'organisation

STERIFAST - STERILIZATION & DISINFECTION SYSTEMS LDA.

SRN

PT-MF-000012426

Statut du fabricant

Actif

Marché principal en Pologne ; disponible dans 2 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

05600778703032

Basic UDI-DI

B-05600778703032

Numéro de référence/catalogue

STFE0502SD-B

Entité d'attribution

GS1

Catégorie de risque

Classe IIb

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

It is a low temperature sterilizer that uses an aqueous solution of hydrogen peroxide in low concentration (35%) as the sterilizing agent, specifically intended to sterilize medical devices in general as well as temperature sensitive medical devices in a medical environment, according to instructions provided in the Instruction Manual. The intended users are specifically health-care professionals. The items to sterilize are placed in the sterilization chamber that is heated at a predefined temperature. Then, the chamber is submitted to a deep vacuum. After, the sterilizing agent is injected into a vaporizer that vaporizes it to the sterilization chamber. The control of the quantity of sterilizing agent is done by the number of pulses of the vaporizer entry valve. After a specific time of exposure to the sterilizing agent, the exhaust opens and the plasma generator is activated until a determined vacuum is reached. Then, a quantity of air is injected in the chamber controlled by pressure. After this phase, the chamber is submitted to several ventilations by entries of air and withdraws by vacuum. After this phase the aeration valve opens and the control systems waits until atmospheric pressure is reached. The cycle ends and the systems prints out a report with the several cycle phases, times, temperature and pressure. The sterilizer has 3 sterilization cycles and 3 test cycles.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• S900199DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER