Instructions for use Lojer Modux nursing bed / Version 2.5
Copyright © Lojer Oy, 2022 54
13.2 Standards used
The device is in conformity with requirements of the EU Medical Device
Regulation 2017/745. The device is marked with CE marking. The device is
classified as Class I medical device.
The following harmonized standards have been used in the design, testing and
manufacturing of the bed collection:
• EN 60601-1:2006 + A1:2013
• EN 60601-1-2:2015
• EN 60601-1-6:2010
• EN 60601-2-52:2010
• EN 60601-1-11:2010
• EN ISO 14971:2012
• EN ISO 13485:2016
• Modux nursing bed is tested and comply with SL1 fire protection class
requirements. SL1 fire protection class approval corresponds to approval
according to standards EN 1021-1 and EN 1021-2.
Image 58. The product fulfils the requirements of SL1 fire protection class
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