LINET Multicare LE

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3 Standards and Regulations
3.1 Multicare LE
The bed complies with the following standards and directives:
EN 60601-1:2006/A1:2013
EN 60601-1-2:2015
EN 60601-2-52:2010
EN ISO 14971:2012
93/42/EEC
90/384/EEC
2011/65/EU
The manufacturer adheres to a certified quality management system in compliance with the following
standards:
EN ISO 9001
EN ISO 14001
EN ISO 13485
3.2 Symbioso
The mattress replacement system complies with the following standards:
 EC directive 93/42/EEC for medical devices
The manufacturer adheres to a certified quality management system in compliance with the following
standards:
EN ISO 9001
EN ISO 13485
EN ISO 14001
The product complies with the requirements of:
EN SO 14001
2011/65/EU (RoHS)
EN 60601-1:2006/A1:2013
EN 60601-1-2:2007
EN 60601-1-6:2010
EN ISO 10993-5:2009