Ropox Slimline Electric 40-15601, Руководство пользователя

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©
ROPOX 2017
33
CE marking
EU – Declaration of confirmity
I, the undersigned, hereby declare that the following products:
Ropox Slimline Electric
Item no.: 40-15601
40-15603
40-15605
40-15607
are in accordance with the following directives and standards:
DIRECTIVES
Directive concerning medical devices 93/42/EEC (Risk class 1)
Machinery Directive no. 2006/42/EG, concerning Machines amended by Directive no. 98/37/EG.
STANDARDS
DS/EN 1041:2009
Information supplied by the manufacturer of medical devices
ISO 17966:2016:
Assistive products for personal hygiene that support users
DS/EN 12182:2012: Assistive products for persons with disability -
General requirements and test methods
DS/EN 14971:2012:
Medical devices – Application of risk management to medical devices
DS/EN 60204-1: Safety of machinery – Electrical equipment of machines - Part 1: General
requirements
DS/EN 60601-1:
Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance
(Applies to the electrical components of the product)
DS/EN 9999:2011: Assistive products for persons with disability -
Classification and terminology
Date: 01-01-2018