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CARDIO LINE 4000 S/S MED/MED/SP/S SP
CARDIO LINE 4100 S/S MED/MED
Technische en optische wijzigingen, alsmede drukfouten voorbehouden - © 2018 by ERGO-FIT GmbH & Co. KG
131
A.9 Notering in het “Medizinproduktebuch“
Conform § 11 lid 7 in verbinding met § 7 van de Verordening over het produceren, verkopen en toepassen van
medische producten (Medizinprodukte-Betreiberverordnung “MPBetreibV”) van 29.06.1998 (BGBt 1. blz. 1762) moet
degene die meettechnische controles uitvoert, de resultaten onmiddellijk in het “Medizinproduktebuch” noteren met
vermelding van de vastgestelde meetwaarden, de meetmethodes en andere beoordelingsresultaten. Aangezien bij de
meettechnische controle van uw medisch product het “Medizinproduktebuch” niet ter beschikking stond, wordt u
verzocht voor uw documentatie de volgende gegevens te gebruike.
Exploitant:
Instelling: __________________________________________
Contactpersoon: __________________________________________
Straat: __________________________________________
Postcode, woonplaats: __________________________________________
Producent:
ERGO-FIT GmbH & Co. KG, Blocksbergstraße 165, D-66955 Pirmasens
Apparaat-identificatie
Benaming: ___________________________________________
Type: ___________________________________________
Seriennummer: ___________________________________________
___________________________________________
Meetmethode en beoordeling volgens:
� Richtlijnen voor meettechnische controles (LMK)
� Bijlage 15 of bijlage 23 bij de ijkvoorschriften (EQ 15 of EQ 23)
� Overige: _____________________________________________
VGebruikte standaard/standaards: ___________________________
Gegevens over de vastgestelde meetwaarden zie volgende bladzijde(s)
� Meettechnische controle in orde; stempel met jaaropgave:
� Meettechnische controle niet in orde; oude stempel ongeldig gemaakt
_______________________________
Handtekening
137


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