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Technical Specification
Directive
Harmonised Standard
Referenced EMC Emission
Standards
MDD 93/42/EEC and MDR 2017/745
EN 60601-1:2006/A1:2013 (Electrical
Safety)
EN 60601-1-2:2007/AC:2010 (EMC)
EN 55011:2009/A1:2010 Class B (RF)
EN 61000-3-2:2014 (Harmonics)
EN 61000-3-3-2013 (Flicker)
Restriction of the use of certain
hazardous substances (RoHS)
Directive. 2011/65/EU
EN 50581:2012
N/A
Toto Touch complies with the following EU Directives and Harmonised Standards:
Compliance
The Toto system conforms to MDD 93/42/EEC and MDR 2017/745 and the following standards:
BS EN ISO 9001:2015 Quality Management Systems. BS EN 13485:2016 Medical Devices. Quality
Management Systems. Requirements for Regulatory Purposes. BS EN 14971:2012 Medical Devices.
Application of Risk Management to Medical Devices. BS EN ISO 15223-1:2016 Medical Devices.
Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied. General
Requirements. BS EN ISO 10993-5:2009 Biological Evaluation of Medical Devices. Tests for In Vitro
Cytotoxicity. BS EN 10993-10:2013 Biological Evaluation of Medical Devices. Tests for Irritation and
Skin Sensitization.The control unit is tested to EU Directive 2014/30/EU and BS EN 62353:2014
Medical Electrical Equipment – Recurrent Test and Test After Repair of Medical Electrical Equipment.
The control unit is tested to EU Directive 2014/30/EU.
Manufactured to comply with EN 60601-1 (Safety) and EN 60601-1-2 (EMC);
IEC/EN 60601-1; IEC /EN 60601-1-11; IEC/EN 60601-1-8.
Restriction of the use of certain hazardous substances (RoHS) Directive. 2011/65/EU
No modification of this equipment is allowed.
Complaints and Adverse Events Reporting
Any healthcare professional (e.g., customer or user of this system of products) who has any complaints
or who have experienced any dissatisfaction in the product quality, identity, durability, reliability,
safety, effectiveness, and performance should notify the distributor or Frontier Therapeutics Ltd.
If any Frontier Therapeutics Ltd. product ever malfunctions and may have caused or contributed
to the death or severe injury of a patient, Frontier Therapeutics Ltd. and your local competent
authority should be notified immediately by telephone, fax or written correspondence. When filing
a complaint, provide the component(s) name and number, lot number(s), your name and address,
the nature of the complaint, and notification of whether or not a written report from the distributor
is requested.
Further Information
If further information is needed or required, contact Frontier Therapeutics Ltd.
on Tel: +44 (0) 330 460 6030 or visit our website www.frontier-group.co.uk.
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