Philips Goldway (Shenzhen) Industrial Inc. Standard and Reliability Center
Philips Goldway (Shenzhen) Industrial Inc. Standard and Reliability Center
| Address(es) |
|
| Website | Not available |
| Status | MEMBER |
| Acceptance date | 2023-05-10 |
Further information
Stage | Country | Name |
|---|---|---|
1 | Singapore |
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 9.4.2.3 Instability fromhorizontal and vertical forces, Clause 9.4.2.4Castors and wheels, Clause 9.4.3 Instability fromunwanted lateral movement (including sliding),Clause 9.6.3 Hand-transmitted vibration, Clause9.7.5 Pressure vessels, Clause 9.8.3 Strength ofPATIENT or OPERATOR support or suspensionsystems, Clause 10 Protection against unwanted andexcessive radiation HAZARDS, Clause 11.2.2 MEEQUIPMENT and ME SYSTEMS used in conjunctionwith OXYGEN RICH ENVIRONMENTS, Clause11.2.3 SINGLE FAULT CONDITIONS related toOXYGEN RICH ENVIRONMENTS in conjunction withME EQUIPMENT and ME SYSTEMS, Clause 11.4ME EQUIPMENT and ME SYSTEMS intended foruse with flammable anesthetics, Clause 11.5 MEEQUIPMENT and ME SYSTEMS intended for use inconjunction with flammable agents, Clause 11.6Overflow, spillage, leakage, ingress of water orparticulate matter, cleaning, disinfection, sterilizationand compatibility with substances used with the MEEQUIPMENT, Clause 11.7 Sterilization of MEEQUIPMENT and ME SYSTEMS, Clause 12Accuracy of controls and instruments and protectionagainst hazardous outputs, Clause 14PROGRAMMABLE ELECTRICAL MEDICALSYSTEMS (PEMS), Clause 15.1 Arrangements ofcontrols and indicators of ME EQUIPMENT, Clause15.3.5 Rough handling test, 15.4.3.4 Lithiumbatteries, Clause 15.4.7 Cord-connected HANDHELDand foot-operated control devices, Clause15.5 MAINS SUPPLY TRANSFORMERS of MEEQUIPMENT and transformers providing separationin accordance with 8.5. | 2023-05-10 | |
MED | IEC 60601-1:2005/AMD1:2012 | All Clauses except Clause 9.4.2.3 Instability fromhorizontal and vertical forces, Clause 9.4.2.4Castors and wheels, Clause 9.4.3 Instability fromunwanted lateral movement (including sliding),Clause 9.6.3 Hand-transmitted vibration, Clause9.7.5 Pressure vessels, Clause 9.8.3 Strength ofPATIENT or OPERATOR support or suspensionsystems, Clause 10 Protection against unwanted andexcessive radiation HAZARDS, Clause 11.2.2 MEEQUIPMENT and ME SYSTEMS used in conjunctionwith OXYGEN RICH ENVIRONMENTS, Clause11.2.3 SINGLE FAULT CONDITIONS related toOXYGEN RICH ENVIRONMENTS in conjunction withME EQUIPMENT and ME SYSTEMS, Clause 11.4ME EQUIPMENT and ME SYSTEMS intended foruse with flammable anesthetics, Clause 11.5 MEEQUIPMENT and ME SYSTEMS intended for use inconjunction with flammable agents, Clause 11.6Overflow, spillage, leakage, ingress of water orparticulate matter, cleaning, disinfection, sterilizationand compatibility with substances used with the MEEQUIPMENT, Clause 11.7 Sterilization of MEEQUIPMENT and ME SYSTEMS, Clause 12Accuracy of controls and instruments and protectionagainst hazardous outputs, Clause 14PROGRAMMABLE ELECTRICAL MEDICALSYSTEMS (PEMS), Clause 15.1 Arrangements ofcontrols and indicators of ME EQUIPMENT, Clause15.3.5 Rough handling test, 15.4.3.4 Lithiumbatteries, Clause 15.4.7 Cord-connected HANDHELDand foot-operated control devices, Clause15.5 MAINS SUPPLY TRANSFORMERS of MEEQUIPMENT and transformers providing separationin accordance with 8.5. | 2023-05-10 | |
MED | IEC 60601-1:2005/AMD2:2020 | All Clauses except Clause 9.4.2.3 Instability fromhorizontal and vertical forces, Clause 9.4.2.4Castors and wheels, Clause 9.4.3 Instability fromunwanted lateral movement (including sliding),Clause 9.6.3 Hand-transmitted vibration, Clause9.7.5 Pressure vessels, Clause 9.8.3 Strength ofPATIENT or OPERATOR support or suspensionsystems, Clause 10 Protection against unwanted andexcessive radiation HAZARDS, Clause 11.2.2 MEEQUIPMENT and ME SYSTEMS used in conjunctionwith OXYGEN RICH ENVIRONMENTS, Clause11.2.3 SINGLE FAULT CONDITIONS related toOXYGEN RICH ENVIRONMENTS in conjunction withME EQUIPMENT and ME SYSTEMS, Clause 11.4ME EQUIPMENT and ME SYSTEMS intended foruse with flammable anesthetics, Clause 11.5 MEEQUIPMENT and ME SYSTEMS intended for use inconjunction with flammable agents, Clause 11.6Overflow, spillage, leakage, ingress of water orparticulate matter, cleaning, disinfection, sterilizationand compatibility with substances used with the MEEQUIPMENT, Clause 11.7 Sterilization of MEEQUIPMENT and ME SYSTEMS, Clause 12Accuracy of controls and instruments and protectionagainst hazardous outputs, Clause 14PROGRAMMABLE ELECTRICAL MEDICALSYSTEMS (PEMS), Clause 15.1 Arrangements ofcontrols and indicators of ME EQUIPMENT, Clause15.3.5 Rough handling test, 15.4.3.4 Lithiumbatteries, Clause 15.4.7 Cord-connected HANDHELDand foot-operated control devices, Clause15.5 MAINS SUPPLY TRANSFORMERS of MEEQUIPMENT and transformers providing separationin accordance with 8.5. | 2023-05-10 | |
MED | IEC 60601-1-8:2006 | Accept clause 6.3.2.2.1 4 m (distant) visual ALARMSIGNALS, clause 6.3.2.2.2 1 m (OPERATOR’SPOSITION) visual ALARM SIGNALS andINFORMATION SIGNALS, clause 6.3.3.2 Volumeand characteristics of auditory ALARM SIGNALS andINFORMATION SIGNALS, clause 6.4.1 ALARMSYSTEM delays, clause 6.5.5 Interruptions of lessthan or equal to 30 s. | 2023-05-10 | |
MED | IEC 60601-1-8:2006/AMD1:2012 | Accept clause 6.3.2.2.1 4 m (distant) visual ALARMSIGNALS, clause 6.3.2.2.2 1 m (OPERATOR’SPOSITION) visual ALARM SIGNALS andINFORMATION SIGNALS, clause 6.3.3.2 Volumeand characteristics of auditory ALARM SIGNALS andINFORMATION SIGNALS, clause 6.4.1 ALARMSYSTEM delays, clause 6.5.5 Interruptions of lessthan or equal to 30 s. | 2023-05-10 | |
MED | IEC 60601-1-8:2006/AMD2:2020 | Accept clause 6.3.2.2.1 4 m (distant) visual ALARMSIGNALS, clause 6.3.2.2.2 1 m (OPERATOR’SPOSITION) visual ALARM SIGNALS andINFORMATION SIGNALS, clause 6.3.3.2 Volumeand characteristics of auditory ALARM SIGNALS andINFORMATION SIGNALS, clause 6.4.1 ALARMSYSTEM delays, clause 6.5.5 Interruptions of lessthan or equal to 30 s. | 2023-05-10 | |
MED | IEC 60601-1-11:2015 | Accept clause 4.2.2 Environmental conditions oftransport and storage between uses, clause 7 MEequipment identification, marking and documents,clause 8.4 Additional requirements for interruption ofthe power supply/SUPPLY MAINS to ME equipmentand ME system, clause 10.1.2 Requirements formechanical strength for non-transit-operable MEEQUIPMENT, clause 10.1.3 Requirements formechanical strength for transit-operable MEequipment, clause 13 Additional requirements for ALARM system of ME equipment and ME systems. | 2023-05-10 | |
MED | IEC 60601-1-11:2015/AMD1:2020 | Accept clause 4.2.2 Environmental conditions oftransport and storage between uses, clause 7 MEequipment identification, marking and documents,clause 8.4 Additional requirements for interruption ofthe power supply/SUPPLY MAINS to ME equipmentand ME system, clause 10.1.2 Requirements formechanical strength for non-transit-operable MEEQUIPMENT, clause 10.1.3 Requirements formechanical strength for transit-operable MEequipment, clause 13 Additional requirements for ALARM system of ME equipment and ME systems. | 2023-05-10 | |
MED | IEC 60601-1-12:2014 | All Clauses except Clause 8.1 Additionalrequirements for ingress of water or particulatematter into ME EQUIPMENT and ME SYSTEMS,Clause 10.1.4 b) Requirements for mechanicalstrength for ME EQUIPMENT intended for airborneuse, Clause 11 Additional requirements forelectromagnetic compatibility of ME EQUIPMENTand ME SYSTEMS. | 2023-05-10 | |
MED | IEC 60601-1-12:2014/AMD1:2020 | All Clauses except Clause 8.1 Additionalrequirements for ingress of water or particulatematter into ME EQUIPMENT and ME SYSTEMS,Clause 10.1.4 b) Requirements for mechanicalstrength for ME EQUIPMENT intended for airborneuse, Clause 11 Additional requirements forelectromagnetic compatibility of ME EQUIPMENTand ME SYSTEMS. | 2023-05-10 | |
MED | IEC 60601-2-4:2010 | All Clauses except Clause 201.11.6.3 Spillage onME EQUIPMENT and ME SYSTEMS, Clause201.11.6.5 Ingress of water or particulate matter intoME EQUIPMENT and ME SYSTEMS, Clause201.11.6.7 Sterilization of ME EQUIPMENT and MESYSTEMS, Clause 201.108 DEFIBRILLATORELECTRODES, Clause 202 Electromagneticcompatibility – Requirements and tests. | 2023-05-10 | |
MED | IEC 60601-2-4:2010/AMD1:2018 | All Clauses except Clause 201.11.6.3 Spillage onME EQUIPMENT and ME SYSTEMS, Clause201.11.6.5 Ingress of water or particulate matter intoME EQUIPMENT and ME SYSTEMS, Clause201.11.6.7 Sterilization of ME EQUIPMENT and MESYSTEMS, Clause 201.108 DEFIBRILLATORELECTRODES, Clause 202 Electromagneticcompatibility – Requirements and tests. | 2023-05-10 | |
MED | IEC 60601-2-25:2011 | Accept Clause 201.8.5.5.1 Defibrillation protection,Clause 201.12.1.101.2 Requirements for amplitudemeasurements, Clause 201.12.1.101.3.1Requirements for absolute interval and waveduration measurements, Clause 201.12.4.102.3.2Requirements for interval measurements onbiological ECGS, Clause 201.12.4.102.4 Protectionagainst hazardous output, Clause 201.12.4.103 Inputimpedance, Clause 201.12.4.105.2 Overloadtolerance, Clause 201.12.4.105.3 FILTERS(including line frequency interference FILTERS),Clause 201.12.4.106 Baseline, Clause 201.12.4.107Sampling and amplitude quantisation during dataacquisition, Clause 201.12.4.108.3 ECG reporting onpaper, Clause 201.12.4.109 Use with cardiacpacemakers, Clause 202.6.2.101 Electrosurgeryinterference. | 2023-05-10 | |
MED | IEC 60601-2-27:2011 | All clauses except clause 202 Electromagneticcompatibility – Requirements and tests. | 2023-05-10 | |
MED | IEC 60601-2-34:2011 | Accept clause 201.8.5.5.1 Defibrillation protection,Clause 201.8.7.4.7 Measurement of the PATIENTLEAKAGE CURRENT, Clause 201.11.8Interruptionof the power supply/SUPPLY MAINS to MEEQUIPMENT, Clause 201.11.8.101Protectionagainst depletion of battery, Clause 201.12.1.101.1Measurement range, sensitivity, repeatability, nonlinearity,drift, and hysteresis, Clause 201.12.1.101.2Accuracy of systolic and diastolic pressure, Clause201.12.1.101.3Frequency response, Clause201.15.3.4.101TRANSDUCER drop test, Clause202.6.2.101Electrosurgery interference, Clause208.6.3.3.1 Characteristics of auditory ALARMSIGNALS, Clause 208.6.6.2.101 PhysiologicalALARM CONDITIONS, ALARM LIMITS and delaytime of physiological ALARM SIGNALS, Clause208.6.6.2.102 Detection of TRANSDUCER andTRANSDUCER cable fault, Clause 208.6.6.2.103 *Detection of disconnected catheter. | 2023-05-10 | |
MED | IEC 60601-2-37:2007 | Accept clause 201.7.9.2.12 Cleaning, disinfectionand sterilization, clause 201.11.1.2.2 APPLIEDPARTS not intended to supply heat to a PATIENT. | 2023-05-10 | |
MED | IEC 60601-2-37:2007/AMD1:2015 | Accept clause 201.7.9.2.12 Cleaning, disinfectionand sterilization, clause 201.11.1.2.2 APPLIEDPARTS not intended to supply heat to a PATIENT. | 2023-05-10 | |
MED | IEC 60601-2-49:2011 | Accept Clause 201.8.5.5.1 Defibrillation protection,201.8.7.1.101 PART LEAKAGE CURRENT, Clause201.11.8 Interruption of the power supply / SUPPLYMAINS to ME EQUIPMENT, Clause 201.11.8.101Protection against depletion of battery, Clause202.6.2.101 Electrosurgery interference, 208.6.3.3.1Characteristics of auditory ALARM SIGNALs. | 2023-05-10 | |
MED | IEC 80601-2-30:2018 | All clauses except clause 201.106 * Clinicalaccuracy, clause 202 Electromagnetic disturbances– Requirements and tests, clause 206 Usability,clause 211.8.3.1 Ingress of water or particulatematter into ME EQUIPMENT. | 2023-05-10 | |
MED | ISO 80601-2-55:2018 | Accept clause 201.12.1.101 *MEASUREMENTACCURACY, clause 201.12.1.1.102 *TOTALSYSTEM RESPONSE TIME and RISE TIME, clause201.15.3.5.101 Additional requirements for shockand vibration, clause 208 General requirements,tests and guidance for ALARM SYSTEMS inMEDICAL ELECTRICAL EQUIPMENT and MEDICALELECTRICAL SYSTEMS | 2023-05-10 | |
MED | ISO 80601-2-56:2017 | All clauses except clause 201.11.7 Biocompatibilityof ME EQUIPMENT and ME SYSTEMS, clause201.102 CLINICAL ACCURACY VALIDATION,clause 202 Electromagnetic disturbances –Requirements and tests, clause 211.10.1.1 Generalrequirements for mechanical strength, clause212.10.1.1 General requirements for mechanicalstrength. | 2023-05-10 | |
MED | ISO 80601-2-56:2017/AMD1:2018 | All clauses except clause 201.11.7 Biocompatibilityof ME EQUIPMENT and ME SYSTEMS, clause201.102 CLINICAL ACCURACY VALIDATION,clause 202 Electromagnetic disturbances –Requirements and tests, clause 211.10.1.1 Generalrequirements for mechanical strength, clause212.10.1.1 General requirements for mechanicalstrength. | 2023-05-10 | |
MED | ISO 80601-2-61:2017 | All clauses except clause 201.10.4 Lasers, clause201.11.6.5.101 Additional requirements for ingressof water or particulate matter into ME EQUIPMENTor ME SYSTEM, clause 201.12 Accuracy of controlsand instruments and protection against hazardousoutputs, clause 201.14 PROGRAMMABLEELECTRICAL MEDICAL SYSTEMS (PEMS), clause201.17 Electromagnetic compatibility of MEEQUIPMENT and ME SYSTEMS, clause 202Electromagnetic disturbances – Requirements andtests. | 2023-05-10 |