The CE mark has the literal meaning of European Conformity and in concrete terms is the graphic demonstration that the product to which it is applied complies with the regulations in force within the European Community and that govern the production and placing on the market of that product.
SpaceWheel products have a European CE marking certificate as a medical device and were built in compliance with the following directives and standards:
• Regulation (EU) n.745 / 2017 Regulation concerning medical devices, which amends directive 2001/83 / EC, regulation (EC) n. 178/2002 and the regulation (CE) n. 1223/2009 and repealing Council Directives 90/385 / EEC and 93/42 / EEC
• IEC 61882: 2016 standard Risk analysis method according to the HAZOP method
• UNI CEI EN 980: 2009 Graphic symbols used for the labeling of medical devices
• UNI CEI EN ISO 15223-1: 2012 Symbols to be used in the medical device labels, labeling and information to be provided - Part 1: General requirements
• UNI CEI EN 1041: 2009 Information provided by the Manufacturer with medical devices
• UNI CEI EN 14971: 2012 Application of risk management to medical devices
• Dir. 93/42 / CEE, D.L. 24/02/97 nr. 46, D.L. 25/02/98 nr. 95 Council Directive concerning medical devices - Implementation of Directive 93/42 / EEC concerning medical devices. Changes to the Legislative Decree 24 February 1997 nr. 46 (which will coexist with the new Regulation until 2020)
• Dir. 2007/47 / CEE D.L. 25/01/10 nr. 37 Council Directive concerning medical devices Implementation of Directive 93/42 / EEC concerning medical devices. (which will coexist with the new Regulation until 2020) • Directive 2006/42 / EC known as the "Machinery Directive". And it therefore complies with the directives and regulations in force. This declaration of conformity is issued under the sole responsibility of the manufacturer.
To download the declaration of conformity, click here.