Nanjing Mindray Bio-Medical Electronics, Ltd
Nanjing Mindray Bio-Medical Electronics, Ltd
| Address(es) |
|
| Website | Not available |
| Status | MEMBER |
| Acceptance date | 2022-05-27 |
Further information
Stage | Country | Name |
|---|---|---|
1 | Belgium |
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:Clause 8.5.5 Defibrillation-proof applied partsClause 8.8.4.2 Resistance to environmental stress test for latex rubberClause 9.5.2 Cathode ray tubesClause 9.6.3 Hand-transmitted vibrationClause 9.8.3.3 Dynamic forces due to loading from personsClause 10.1 X-RadiationClause 10.3 Microwave radiationClause 10.4 LasersClause 11.2.2 ME EQUIPMENT and ME SYSTEMS used in conjunction with OXYGEN RICH ENVIRONMENTS Clause 11.4 ME EQUIPMENT and ME SYSTEMS intended for use with flammable anaestheticsClause 11.5 ME EQUIPMENT and ME SYSTEMS intended for use in conjunction with flammable agentsClause 11.6.7 Sterilization of ME EQUIPMENT and ME SYSTEMSClause 11.7 Biocompatibility of ME EQUIPMENT and ME SYSTEMSClause 15.4.2 Tests according to 60730-1Annex G Protection against HAZARDS of ignition of flammable anaesthetic mixtures | 2022-05-27 | |
MED | IEC 60601-1:2005/AMD1:2012 | All clauses except:Clause 8.5.5 Defibrillation-proof applied partsClause 8.8.4.2 Resistance to environmental stress test for latex rubberClause 9.5.2 Cathode ray tubesClause 9.6.3 Hand-transmitted vibrationClause 9.8.3.3 Dynamic forces due to loading from personsClause 10.1 X-RadiationClause 10.3 Microwave radiationClause 10.4 LasersClause 11.2.2 ME EQUIPMENT and ME SYSTEMS used in conjunction with OXYGEN RICH ENVIRONMENTS Clause 11.4 ME EQUIPMENT and ME SYSTEMS intended for use with flammable anaestheticsClause 11.5 ME EQUIPMENT and ME SYSTEMS intended for use in conjunction with flammable agentsClause 11.6.7 Sterilization of ME EQUIPMENT and ME SYSTEMSClause 11.7 Biocompatibility of ME EQUIPMENT and ME SYSTEMSClause 15.4.2 Tests according to 60730-1Annex G Protection against HAZARDS of ignition of flammable anaesthetic mixtures | 2022-05-27 | |
MED | IEC 60601-1:2005/AMD2:2020 | All clauses except:Clause 8.5.5 Defibrillation-proof applied partsClause 8.8.4.2 Resistance to environmental stress test for latex rubberClause 9.5.2 Cathode ray tubesClause 9.6.3 Hand-transmitted vibrationClause 9.8.3.3 Dynamic forces due to loading from personsClause 10.1 X-RadiationClause 10.3 Microwave radiationClause 10.4 LasersClause 11.2.2 ME EQUIPMENT and ME SYSTEMS used in conjunction with OXYGEN RICH ENVIRONMENTS Clause 11.4 ME EQUIPMENT and ME SYSTEMS intended for use with flammable anaestheticsClause 11.5 ME EQUIPMENT and ME SYSTEMS intended for use in conjunction with flammable agentsClause 11.6.7 Sterilization of ME EQUIPMENT and ME SYSTEMSClause 11.7 Biocompatibility of ME EQUIPMENT and ME SYSTEMSClause 15.4.2 Tests according to 60730-1Annex G Protection against HAZARDS of ignition of flammable anaesthetic mixtures | 2022-05-27 | |
MED | IEC 60601-2-41:2009 | All clauses except:Clause 201.10.7 Ultraviolet radiation | 2022-05-27 | |
MED | IEC 60601-2-41:2009/AMD1:2013 | All clauses except:Clause 201.10.7 Ultraviolet radiation | 2022-05-27 | |
MED | IEC 60601-2-46:2016 | All clauses | 2022-05-27 |