ESAOTE S.P.A.
ESAOTE S.P.A.
| Address(es) |
|
| Website | Not available |
| Status | MEMBER |
| Acceptance date | 2008-12-16 |
Further information
Stage | Country | Name |
|---|---|---|
2 | Germany |
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 | accepted clauses for Stage 1 and for Stage 2: (all clauses except clauses 10.4, 11.7, 12.3, 17, Annexes G & L) | 2008-12-16 | |
MED | IEC 60601-1:2005/AMD1:2012 | accepted clauses for Stage 1 and for Stage 2: (all clauses except clauses 10.4, 11.7, 12.3, 17, Annexes G & L) | 2008-12-16 | |
MED | IEC 60601-1:2005/AMD2:2020 | (all clauses except clauses 10.4, 11.7, 12.3, 17, Annexes G & L) | 2020-11-02 | |
MED | IEC 60601-2-33:2022 | (all clauses except clauses 201.17 and 202) | 2025-02-07 | |
MED | IEC 60601-2-33:2010 | accepted clauses for Stage 1 and for Stage 2: ( all clauses except clauses 201.17 and 202) | 2008-12-16 | |
MED | IEC 60601-2-33:2010/AMD1:2013 | accepted clauses for Stage 1 and for Stage 2: ( all clauses except clauses 201.17 and 202) | 2008-12-16 | |
MED | IEC 60601-2-33:2010/AMD2:2015 | accepted clauses for Stage 1 and for Stage 2: ( all clauses except clauses 201.17 and 202) | 2019-03-08 | |
MED | IEC 60601-2-37:2007 | Accepted clauses: 201.7.9.3.101 Technical data regarding acoustic output levels201.8.7.4.7 Measurement of the Patient leakage current201.8.7.4.8 Measurement of the patient auxiliary current201.8.8.3 Dielectric strenght201.8.9.3.4 Thermal cycling201.11 Protection against excessive temperatures and other hazards201.12 Accuracy of controls and instruments and protection against hazardous outputs) | 2022-02-15 | |
MED | IEC 60601-2-37:2007/AMD1:2015 | Accepted clauses: 201.7.9.3.101 Technical data regarding acoustic output levels201.8.7.4.7 Measurement of the Patient leakage current201.8.7.4.8 Measurement of the patient auxiliary current201.8.8.3 Dielectric strenght201.8.9.3.4 Thermal cycling201.11 Protection against excessive temperatures and other hazards201.12 Accuracy of controls and instruments and protection against hazardous outputs) | 2022-02-15 |