Profound Medical Oy
Profound Medical Oy
Address(es) |
|
Website | Not available |
Status | MEMBER |
Acceptance date | 2018-09-20 |
Further information
Stage | Country | Name |
---|---|---|
1 | Finland |
LEGEND: Scope Limitations
- RA : Audio amplifiers with audio power > 0,5 Watts excluded
- RC : Apparatus with connection(s) to a cable distribution system excluded
- RSH : Shredders excluded
- RT : Apparatus with connection(s) to a telecommunication network excluded
- RV : CRT (cathode ray tubes)/ picture tubes, plasma/LCD or other video apparatus excluded
- ROUT : Equipment intended for installation outdoors excluded
- RWPT : Wireless power transmitter excluded
Category | Name | Tests/Clauses | Acceptance Date | Responsible National Certification Body |
---|---|---|---|---|
MED | IEC 60601-1:2005 | All clauses except:11.6.5 (Ingress of liquids and particulate matter into ME EQUIPMENT and ME SYSTEMS, 8.9.3.4 (Thermal cycling) | 2018-09-20 | |
MED | IEC 60601-1:2005/AMD1:2012 | All clauses except:11.6.5 (Ingress of liquids and particulate matter into ME EQUIPMENT and ME SYSTEMS, 8.9.3.4 (Thermal cycling) | 2018-09-20 | |
MED | IEC 60601-1:2005/AMD2:2020 | All clauses except: 11.6.5 (Ingress of liquids and particulate matter into ME EQUIPMENT and ME SYSTEMS 8.9.3.4 (Thermal cycling) | 2023-12-11 | |
MED | IEC 60601-2-62:2013 | Clauses:201.10.101 Ultrasonic energy,201.10.102 Unwanted ultrasound radiation of hand-held transducers,201.10.103 Unintended heating of tissue, 201.12.1.101 Patient Entry Power, 201.12.1.102 Targeting Accuracy,201.12.4.4.103 Unintended output levels | 2018-09-20 |