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Declaration of conformity
Manufacturer:
Product description/model
Hermann Bock GmbH
Nickelstraße 12
33415 Verl
practico ultra low 9.5/80
Classification:
Choose conformity evaluation process:
Medical products class I,
norm 1 and 12 referring to appendix IX of MDD
Annex VII of MDD
Hereby we declare that the above specified products comply with the provisions of the directive
93/42/EWC concerning advice for medical products. The entire associated documentation is kept in the
premises of the manufacturer.
Applied standards:
Harmonized standards for which the proof of concordance
can be supplied:
EN 60601-1:2006
Medical electric devices - part 1:
General definitions for the safety - including the essential
performance characteristics
EN 60601-1-2:2007
Medical electric devices - part 1-2:
General definitions for the safety - including the essential
performance characteristics - collateral standard: Electro-
magnetic tolerance – requirements and testing.
EN 60601-2-52:2010
Medical electric devices - part 2-52:
General definitions for the safety - including the essential
performance characteristics of medical beds.
EN ISO 14971:2012
Application of the risk management for medical products.
Verl, 15. September 2015
_____________________________
________________________________
Klaus Bock
Dr. Stefan Kettelhoit
(Company management)
(Company management)
Summary of Contents for practico ultra low 9.5/80
Page 1: ...Installation Instruction and User Manual practico ultra low 9 5 80 ...
Page 33: ...33 8 Guidelines and manufacturer s declaration ...
Page 34: ...34 ...
Page 37: ...37 ...