Standard Title
EN 61326-1:2013 Electrical equipment for measurement, control and laboratory use.
EMC requirements. General requirements.
IEC 62304:2006+AMD1:2015 Medical device software. Software life-cycle processes.
IEC 62366-1:2015+AMD1:2020 Medical devices — Part 1: Application of usability engineering to
medical devices.
Table 2.1 Applied Standards (continued)
2.6 Compliance
This equipment has been designed to perform within the guidelines recommended by
international decontamination standards. A stringent quality control program ensures that
every unit is manufactured and tested under controlled conditions to ensure that all
products perform identically.
2.7 RoHS Requirements
The equipment manufacturer is committed to meeting or exceeding the requirements of
the RoHS CE Marking Directive 2011/65/EC, "Restriction of the Use of Certain Hazardous
Substances in Electrical and Electronic Equipment".
2.8 Disposal of Equipment
This equipment contains materials which may require disposal through appropriately
licensed and permitted hazardous waste management firms.
GENERAL INFORMATION 15
InnoWave Unity & Unity 20 Operator Manual
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