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CARDIO LINE 400/400 MED
Modifications techniques ou optiques et erreurs d‘impression réservées. - © 2019 by ERGO-FIT GmbH & Co. KG7
81
A.9 Inscription dans le livre des produits médicaux
Selon l‘article 11, paragraphe 7 et l‘article 7 du décret sur l‘érection, l‘exploitation et l‘utilisation de produits médicaux
(Medizinprodukte-Betreiberverordnung „MPBetreibV“) du 29.06.1998 (BGBt 1, page 1762), la personne effectuant des
contrôles métrologiques est obligé d‘inscrire immédiatement les valeurs mesurées, les méthodes de mesure ainsi que
d‘autres résultats d‘évaluation dans le livre des produits médicaux. Comme le livre des produits médicaux n‘était pas
valable au moment des contrôles métrologiques de votre appareil médical, veuillez utiliser les indications suivantes
pour votre documentation.
Exploitant:
Entreprise: __________________________________________
Interlocuteur: __________________________________________
Rue: __________________________________________
Code postal, lieu: __________________________________________
Producteur:
ERGO-FIT GmbH & Co. KG, Blocksbergstraße 165, D-66955 Pirmasens
Identification de l‘appareil
Dénomination de l‘appareil: _______________________________________
Modèle: ____________________________________________
Numéro de série: ____________________________________________
____________________________________________
Méthode de mesure et évaluation selon:
 Leitfaden zu messtechnischen Kontrollen (LMK)
Annexe 15 ou annexe 23 du Code d‘étalonnage (EQ 15 ou EQ 23)
 Remarque: _______________________________________
Etalon(s) utilisé(s): ___________________________
Indication des valeurs mesurées sur les pages suivantes)
 Contrôle métrologique : réussi ; Indication de l‘année ; Cachet
 Contrôle métrologique: échoué ; Cachet dévalorisé
_______________________________
Signature
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