Shenzhen Comen Medical Instrument Co., Ltd.
Shenzhen Comen Medical Instrument Co., Ltd.
| Address(es) |
|
| Website | Not available |
| Status | MEMBER |
| Acceptance date | 2023-09-22 |
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 | Accepted clauses: 7.2.1, 7.2.2, 7.3 (Conducted Emission, Radiated Emission (30MHz-1GHz, small size equipment), Harmonic distortion (less than 16A), Voltage fluctuations and flicker (less than 16A)) and 8.9 (Electrostatic Discharge, Radiated RF EM field, Electrical Fast Transients / Bursts, Surges, Conducted Disturbances Induced by RF Fields, Rated power frequency magnetic fields, Voltage Dips and Interruptions) | 2023-09-22 | |
EMC | IEC 60601-1-2:2014/AMD1:2020 | Accepted clauses: 7.2.1, 7.2.2, 7.3 (Conducted Emission, Radiated Emission (30MHz-1GHz, small size equipment), Harmonic distortion (less than 16A), Voltage fluctuations and flicker (less than 16A)) and 8.9 (Electrostatic Discharge, Radiated RF EM field, Electrical Fast Transients / Bursts, Surges, Conducted Disturbances Induced by RF Fields, Rated power frequency magnetic fields, Voltage Dips and Interruptions) | 2023-09-22 | |
EMC | IEC 61326-1:2020 | Accepted Clauses: 6.2 (excluding Electromagnetic field 80MHz to 6GHz) and 7.2 (Conducted Emission, Radiated Emission (30MHz-1GHz, small size equipment), Harmonic distortion (less than 16A), Voltage fluctuations and flicker (less than 16A)). | 2023-09-22 | |
EMC | IEC 61326-2-6:2020 | Accepted Clauses: 6.2 (excluding Electromagnetic field 80MHz to 6GHz) and 7(Conducted Emission, Radiated Emission (30MHz-1GHz, small size equipment), Harmonic distortion (less than 16A), Voltage fluctuations and flicker (less than 16A)). | 2023-09-22 | |
MEAS | IEC 61010-1:2010 | Accepted Clauses: 4 5, 6, 7, 8, 9, 10(Excluding 10.5.3), 11, 13.2.2, 14 and 15. | 2023-09-22 | |
MEAS | IEC 61010-1:2010/AMD1:2016 | Accepted Clauses: 4 5, 6, 7, 8, 9, 10(Excluding 10.5.3), 11, 13.2.2, 14 and 15. | 2023-09-22 | |
MEAS | IEC 61010-2-010:2019 | Accepted Clauses: 5, 6, 7, 8, 9, 10, 11, 14. | 2023-09-22 | |
MEAS | IEC 61010-2-081:2019 | Accepted Clauses: 5, 6, 7, 8. | 2023-09-22 | |
MEAS | IEC 61010-2-101:2018 | Accepted Clauses: 5, 6, 7, 8. | 2023-09-22 | |
MED | IEC 60601-1:2005 | Accepted clauses: 4, 5, 7, 8, 9 (excluding 9.5, 9.6.3, 9.7.5),11 (excluding IPX5-IPX8), 12, 13, 15 (excluding 15.4.2) and 16 | 2023-09-22 | |
MED | IEC 60601-1:2005/AMD1:2012 | Accepted clauses: 4, 5, 7, 8, 9 (excluding 9.5, 9.6.3, 9.7.5),11 (excluding IPX5-IPX8), 12, 13, 15 (excluding 15.4.2) and 16 | 2023-09-22 | |
MED | IEC 60601-1:2005/AMD2:2020 | Accepted clauses: 4, 5, 7, 8, 9 (excluding 9.5, 9.6.3, 9.7.5),11 (excluding IPX5-IPX8), 12, 13, 15 (excluding 15.4.2) and 16 | 2023-09-22 | |
MED | IEC 60601-1-8:2006 | Accepted clauses: 4, 5 and 6. | 2023-09-22 | |
MED | IEC 60601-1-8:2006/AMD1:2012 | Accepted clauses: 4, 5 and 6. | 2023-09-22 | |
MED | IEC 60601-1-8:2006/AMD2:2020 | Accepted clauses: 4, 5 and 6. | 2023-09-22 | |
MED | IEC 60601-2-4:2010 | Accepted clauses: 201.4, 201.5, 201.6, 201.7, 201.8, 201.9, 201.11, 201.12, 201.13, 201.15, 201.16, 201.17, 201.101 to 201.109 and 202. | 2023-09-22 | |
MED | IEC 60601-2-4:2010/AMD1:2018 | Accepted clauses: 201.4, 201.5, 201.6, 201.7, 201.8, 201.9, 201.11, 201.12, 201.13, 201.15, 201.16, 201.17, 201.101 to 201.109 and 202. | 2023-09-22 | |
MED | IEC 60601-2-18:2009 | Accepted clauses: 201.4, 201.5, 201.6, 201.7, 201.8, 201.9, 201.10, 201.11, 201.12, 201.13, 201.15, 201.16, 201.17 and 202 | 2023-09-22 | |
MED | IEC 60601-2-19:2020 | Accepted clauses: 201.4, 201.5, 201.6, 201.7, 201.8, 201.9, 201.11, 201.12, 201.13, 201.15, 201.16, 201.17, and 202. | 2023-09-22 | |
MED | IEC 60601-2-21:2020 | Accepted clauses: 201.4, 201.5, 201.6, 201.7, 201.8, 201.9, 201.10, 201.11, 201.12, 201.13, 201.15, 201.16, 201.17, and 202. | 2023-09-22 | |
MED | IEC 60601-2-24:2012 | Accepted clauses: 201.4, 201.5, 201.6, 201.7, 201.8, 201.9, 201.10, 201.11, 201.12, 201.13, 201.15, 201.16, 201.17, 202, and 208. | 2023-09-22 | |
MED | IEC 60601-2-25:2011 | Accepted clauses: 201.4, 201.5, 201.6, 201.7, 201.8, 201.9, 201.11, 201.12, 201.13, 201.15, 201.16, 201.17 and 202. | 2023-09-22 | |
MED | IEC 60601-2-27:2011 | Accepted clauses: 201.4, 201.5, 201.6, 201.7, 201.8, 201.9, 201.11, 201.12, 201.13, 201.15, 201.16, 202 and 208. | 2023-09-22 | |
MED | IEC 60601-2-34:2011 | Accepted clauses: 201.4, 201.5, 201.6, 201.7, 201.8, 201.9, 201.11, 201.12, 201.13, 201.15, 201.16, 202 and 208. | 2023-09-22 | |
MED | IEC 60601-2-35:2020 | Accepted clauses: 201.4, 201.5, 201.6,201.7, 201.8 (Excluding 201.8.8.4.101), 201.9, 201.10, 201.11, 201.12, 201.13, 201.15 (Excluding 201.15.4.102), 201.16, and 201.17, 202, 208 and 210. | 2023-09-22 | |
MED | IEC 60601-2-37:2007 | Accepted clauses: 201.4, 201.5, 201.6, 201.7, 201.8, 201.9, 201.10, 201.11 (Excluding IPX7 of 201.11.6.5), 201.12, 201.13, 201.15, 201.16, 201.17 and 202.6. | 2023-09-22 | |
MED | IEC 60601-2-37:2007/AMD1:2015 | Accepted clauses: 201.4, 201.5, 201.6, 201.7, 201.8, 201.9, 201.10, 201.11 (Excluding IPX7 of 201.11.6.5), 201.12, 201.13, 201.15, 201.16, 201.17 and 202.6. | 2023-09-22 | |
MED | IEC 60601-2-40:2016 | Accepted clauses: 201.4, 201.5, 201.6, 201.7, 201.8, 201.9, 201.10, 201.11, 201.12 (Excluding 201.12.4.104), 201.13, 201.15, 201.16, 201.17 and 202. | 2023-09-22 | |
MED | IEC 60601-2-41:2009 | Accepted clauses: 201.4, 201.5, 201.6, 201.7, 201.8, 201.9, 201.10, 201.11, 201.12, 201.13, 201.15, 201.16 and 201.17. | 2023-09-22 | |
MED | IEC 60601-2-41:2009/AMD1:2013 | Accepted clauses: 201.4, 201.5, 201.6, 201.7, 201.8, 201.9, 201.10, 201.11, 201.12, 201.13, 201.15, 201.16 and 201.17. | 2023-09-22 | |
MED | IEC 60601-2-46:2016 | Accepted clauses: 201.4, 201.5, 201.6, 201.7, 201.8, 201.9, 201.10, 201.11, 201.12, 201.13, 201.15, 201.16, and 201.17 and 202. | 2023-09-22 | |
MED | IEC 60601-2-50:2020 | Accepted clauses: 201.4, 201.5, 201.6, 201.7, 201.8, 201.9, 201.10, 201.11, 201.12, 201.13, 201.15, 201.16, 201.17 and 202. | 2023-09-22 | |
MED | IEC 80601-2-26:2019 | Accepted clauses: 201.4, 201.5, 201.7, 201.8, 201.9, 201.11, 201.12, 201.13, 201.15, 201.16 and 202. | 2023-09-22 | |
MED | IEC 80601-2-30:2018 | Accepted clauses: 201.4, 201.5, 201.6,201.7, 201.8, 201.9, 201.11, 201.12, 201.13, 201.16, 201.101 to 201.106, 202, and 211. | 2023-09-22 | |
MED | IEC 80601-2-49:2018 | Accepted clauses: 201.4, 201.5, 201.6, 201.7, 201.8, 201.9, 201.11, 201.12, 201.13, 201.15, 201.16, 201.17 and 208 | 2023-09-22 | |
MED | ISO 80601-2-12:2020 | Accepted clauses: 201.4, 201.5, 201.6, 201.7, 201.8, 201.9, 201.11, 201.12, 201.13, 201.15(Excluding 201.15.3.5.101), 201.16, 201.17, 201.101 to 201.108, 202 and 208. | 2023-09-22 | |
MED | ISO 80601-2-13:2011 | Accepted clauses: 201.4, 201.5, 201.6, 201.7, 201.8, 201.9, 201.10, 201.11, 201.12, 201.13, 201.15, 201.16, 201.17, 201.101 to 201.106,202 and 208. | 2023-09-22 | |
MED | ISO 80601-2-13:2011/AMD1:2015 | Accepted clauses: 201.4, 201.5, 201.6, 201.7, 201.8, 201.9, 201.10, 201.11, 201.12, 201.13, 201.15, 201.16, 201.17, 201.101 to 201.106,202 and 208. | 2023-09-22 | |
MED | ISO 80601-2-13:2011/AMD2:2018 | Accepted clauses: 201.4, 201.5, 201.6, 201.7, 201.8, 201.9, 201.10, 201.11, 201.12, 201.13, 201.15, 201.16, 201.17, 201.101 to 201.106,202 and 208. | 2023-09-22 | |
MED | ISO 80601-2-55:2018 | Accepted clauses: 201.4, 201.5, 201.6, 201.7, 201.8, 201.9, 201.10, 201.11, 201.12, 201.13, 201.15 (Excluding 201.15.3.5.101), 201.16, 201.101 to 201.106, 202 and 208. | 2023-09-22 | |
MED | ISO 80601-2-56:2017 | Accepted clauses: 201.4, 201.5, 201.6, 201.7, 201.8, 201.9, 201.11, 201.12, 201.13, 201.15, 201.16, 201.17, 201.101, 201.103, and 208. | 2023-09-22 | |
MED | ISO 80601-2-56:2017/AMD1:2018 | Accepted clauses: 201.4, 201.5, 201.6, 201.7, 201.8, 201.9, 201.11, 201.12, 201.13, 201.15, 201.16, 201.17, 201.101, 201.103, and 208. | 2023-09-22 | |
MED | ISO 80601-2-61:2017 | Accepted clauses: 201.4, 201.5, 201.6, 201.7, 201.8, 201.9, 201.11, 201.12, 201.13, 201.15.101, 201.16, 201.17, 201.101, 201.102, 201.103 and 208. | 2023-09-22 | |
MED | ISO 80601-2-70:2020 | Accepted clauses: 201.4, 201.5, 201.6, 201.7, 201.8, 201.9, 201.10, 201.11, 201.12, 201.13, 201.15, 201.16, 201.101 to 201.104, 202 and 208. | 2023-09-22 | |
MED | ISO 80601-2-72:2015 | Accepted clauses: 201.4, 201.5, 201.6, 201.7, 201.8, 201.9, 201.10, 201.11, 201.12, 201.13, 201.15, 201.16, 201.101 to 201.109,202 and 208. | 2023-09-22 | |
MED | ISO 80601-2-74:2021 | Accepted clauses: 201.4, 201.5, 201.6, 201.7, 201.8, 201.9, 201.11, 201.12, 201.13, 201.15, 201.16, 201.101 to 201.104, 202 and 208. | 2023-09-22 | |
MED | ISO 80601-2-90:2021 | Accepted clauses: 201.4, 201.5, 201.6, 201.7, 201.8, 201.9, 201.11, 201.12, 201.13, 201.15, 201.16, 201.101 to 201.106, 202 and 208. | 2023-09-22 |