GE Healthcare Finland Oy
GE Healthcare Finland Oy
| Address(es) |
|
| Website | Not available |
| Status | MEMBER |
| Acceptance date | 2016-08-03 |
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 |
|---|---|---|---|---|
EMC | IEC 60601-1-2:2014 | 7.3 Table 2 except conducted and radiated emissions, Clause 8 table 4 except test according to IEC 61000-4-3, Clause 8 table 5, Clause 8 table 6 except tests according ISO 7637-2, Clause 8 table 7, Clause 8 table 8. | 2020-02-11 | |
EMC | IEC 60601-1-2:2014/AMD1:2020 | 7.3 Table 2 except radiated emissions, Clause 8 table 4 except test according to IEC 61000-4-3, Clause 8 table 5, Clause 8 table 6 except tests according ISO 7637-2, Clause 8 table 7, Clause 8 table 8, Clause 8.11 | 2021-09-06 | |
MED | IEC 60601-1:2005 | Accepted clauses: 8.5.5, 8.9.3, 11.1, 13 (to the appropriate extent) and 15.5.1. | 2016-08-03 | |
MED | IEC 60601-1:2005/AMD1:2012 | Accepted clauses: clauses 8.5.4, 8.5.5, 8.9.3, 9.8.2, 11.1, 13 (to the appropriate extent) and 15.5.1. | 2016-08-03 | |
MED | IEC 60601-1:2005/AMD2:2020 | Accepted clauses: 8.5.5, 8.9.3, 11.1, 13 (to the appropriate extent) and 15.5.1. | 2021-06-04 | |
MED | IEC 60601-1-8:2006 | 6.4.2, 6.11.2.1, 6.11.2.2.1, 6.11.2.2.3, 6.11.2.3. | 2018-05-21 | |
MED | IEC 60601-1-8:2006/AMD1:2012 | 6.4.2, 6.11.2.1, 6.11.2.2.1, 6.11.2.2.3, 6.11.2.3. | 2018-05-21 | |
MED | IEC 60601-1-8:2006/AMD2:2020 | accepted clauses: 6.4.2, 6.11.2.1, 6.11.2.2.1, 6.11.2.2.3, 6.11.2.3. | 2021-06-04 | |
MED | IEC 60601-2-25:2011 | Accepted clauses: 201.8.5.5.1, 201.8.5.5.2, 201.12.4.102.3.2 and 202.6.2.101. | 2016-08-03 | |
MED | IEC 60601-2-26:2012 | Accepted clauses: 201.8.5.5.1, 201.8.5.5.2 | 2016-08-03 | |
MED | IEC 60601-2-27:2011 | Accepted clause: 201.8.5.5.1, 201.8.5.5.2, 201.12.1.101.13, 208.6.11 and 202.6.2.101. | 2016-08-03 | |
MED | IEC 60601-2-34:2011 | Accepted clause: 201.8.5.5.1, 208.6.11 and 202.6.2.101. | 2016-08-03 | |
MED | IEC 60601-2-40:2016 | Accepted Clauses: Annex AA.4. | 2020-02-11 | |
MED | IEC 60601-2-49:2011 | Accepted clauses: 201.8.5.5.1, 208.6.11. | 2016-08-03 | |
MED | IEC 80601-2-26:2019 | Accepted clauses: 201.8.5.5.1, 201.8.5.5.2, 202.8.101. | 2019-10-21 | |
MED | IEC 80601-2-30:2018 | Accepted clauses: 201.12.1.101, 201.12.1.104, 201.12.1.105, 201.12.1.107, 201.104, 201.105, 202.8.101. | 2019-10-21 | |
MED | IEC 80601-2-30:2009 | Accepted clauses: 201.12.1.105, 201.12.1.107, 201.104, 201.105 | 2016-08-03 | |
MED | IEC 80601-2-30:2009/AMD1:2013 | Accepted clauses: 201.12.1.105, 201.12.1.107, 201.104, 201.105 | 2016-08-03 | |
MED | IEC 80601-2-49:2018 | Accepted clauses: 201.8.5.5.1, 208.6.12, 202.8.102. | 2019-10-21 | |
MED | ISO 80601-2-55:2018 | Accepted clauses: 201.4.3.101, 201.12.1.101, 201.12.1.102, 201.104, 201.105, 201.106 and 208.6.1.2. | 2019-10-21 | |
MED | ISO 80601-2-55:2011 | Accepted clauses: 201.4.3.101, 201.12.1.101 Measurement accuracy, 201.12.1.102 Total system response time and rise time, 201.104 Minimum sampling flowrate, 201.105 Contamination of breathing systems, 208.6.1.2 Alarm condition priority | 2016-08-03 | |
MED | ISO 80601-2-61:2017 | Accepted clauses: 201.4.102 and 201.103. | 2019-10-21 | |
MED | ISO 80601-2-61:2011 | accepted clauses: 201.4.101 | 2016-12-07 |