Product Certifications and Approvals
In this section are the approvals and certifications specific to products. The general approvals for Smartline as a whole are found further down on this page.
EN16442 Compliance
Smartline cabinets are tested and approved to European Standard EN16442:2015 Controlled Environment Storage Cabinet for Processed Thermolabile Endoscopes. See certificates below.
Australian TGA (Therapeutic Goods Administration) Class 1 Medical Device Approval
Attached below are the TGA Certificates for Smartline’s endoscope cabinets. These are registered as Class 1 Medical Devices.
CE Mark and Approval
Smartline cabinets have CE approval, with the addition to the MDR still pending. Details will be uploaded here once the MDR application has been approved.
61010 Testing and Compliance
Smartline endoscope cabinets have been tested to the 61010 standard.
EMC Testing Compliance
Smartline Endoscope cabinets are compliant to the following industry bodies:
ROHS Compliance Statement
Certificate of Free Sale
TGA Schedule 1 to Certificate Number 22/235 - for the export of medical devices.
Company Accreditations and Approvals
Smartline is accredited to ISO 9001:2015 standard in addition to meeting all relevant Australian employment and civil laws.