Product: Eleganza 1
Version: 01
11/68
3 Standards and Regulations
The bed complies with the following standards and directives:
EN 60601-1:2006/A1:2013
EN 60601-1-2:2007
EN 60601-1-6:2010
EN 60601-2-52:2010
EN ISO 10993-5:2009
EN ISO 10993-10:2013
93/42/EEC
2011/65/EU
The manufacturer adheres to a certified quality management system in compliance with the following
standards:
EN ISO 9001:2015
EN ISO 14001:2015
EN ISO 13485:2012