Skanray Technologies Ltd.
Skanray Technologies Ltd.
Address(es) |
|
Website | Not available |
Status | MEMBER |
Acceptance date | 2019-06-12 |
Further information
Stage | Country | Name |
---|---|---|
1 | Denmark |
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 | 4.11, 5.7, 5.9.2, 7.1.2, 7.1.3, 8.4.3, 8.5.4, 8.6.4 a, 8.7, 8.7.4.5, 8.7.4.6, 8.7.4.7 a), 8.7.3 e), 8.8.3, 8.8.4.1, 8.11.3.5, 8.11.4.3, 9.2.2.2, 9.2.3.2, 9.3, 9.4.2.1, 9.4.2.2, 9.4.2.2, 9.4.2.3, 9.4.2.4, 9.4.3.1, 9.4.3.2, 9.6.2.1, 9.8.2, 9.8.3.1, 9.8.3.2, 9.8.3.3, 11.1, 11.1.3 11.6.3, 11.6.5, 11.6.6, 11.8, 13, 13.2, 13.2.13.3 b, 15.3.2, 15.3.3, 15.3.4, 15.4.6, 15.4.7.1, 15.5.1.2, 15.5.1.3, 15.5.2 | 2023-03-30 | |
MED | IEC 60601-1:2005/AMD1:2012 | 4.11, 5.7, 5.9.2, 7.1.2, 7.1.3, 8.4.3, 8.5.4, 8.6.4 a, 8.7, 8.7.4.5, 8.7.4.6, 8.7.4.7 a), 8.7.3 e), 8.8.3, 8.8.4.1, 8.11.3.5, 8.11.4.3, 9.2.2.2, 9.2.3.2, 9.3, 9.4.2.1, 9.4.2.2, 9.4.2.2, 9.4.2.3, 9.4.2.4, 9.4.3.1, 9.4.3.2, 9.6.2.1, 9.8.2, 9.8.3.1, 9.8.3.2, 9.8.3.3, 11.1, 11.1.3 11.6.3, 11.6.5, 11.6.6, 11.8, 13, 13.2, 13.2.13.3 b, 15.3.2, 15.3.3, 15.3.4, 15.4.6, 15.4.7.1, 15.5.1.2, 15.5.1.3, 15.5.2 | 2023-03-30 | |
MED | IEC 60601-1:2005/AMD2:2020 | 4.11, 5.7, 5.9.2, 7.1.2, 7.1.3, 8.4.3, 8.5.4, 8.6.4 a, 8.7, 8.7.4.5, 8.7.4.6, 8.7.4.7 a), 8.7.3 e), 8.8.3, 8.8.4.1, 8.11.3.5, 8.11.4.3, 9.2.2.2, 9.2.3.2, 9.3, 9.4.2.1, 9.4.2.2, 9.4.2.2, 9.4.2.3, 9.4.2.4, 9.4.3.1, 9.4.3.2, 9.6.2.1, 9.8.2, 9.8.3.1, 9.8.3.2, 9.8.3.3, 11.1, 11.1.3 11.6.3, 11.6.5, 11.6.6, 11.8, 13, 13.2, 13.2.13.3 b, 15.3.2, 15.3.3, 15.3.4, 15.4.6, 15.4.7.1, 15.5.1.2, 15.5.1.3, 15.5.2 | 2023-03-30 | |
MED | IEC 60601-1-8:2006 | 6.3.3.1 Characteristics of auditory alarm signals6.3.3.2 Characteristics of visual alarm signals6.3.3.3 Volume of auditory alarm signals and information signals | 2023-03-30 | |
MED | IEC 60601-1-8:2006/AMD1:2012 | 6.3.3.1 Characteristics of auditory alarm signals6.3.3.2 Characteristics of visual alarm signals6.3.3.3 Volume of auditory alarm signals and information signals | 2023-03-30 | |
MED | IEC 60601-1-8:2006/AMD2:2020 | 6.3.3.1 Characteristics of auditory alarm signals6.3.3.2 Characteristics of visual alarm signals6.3.3.3 Volume of auditory alarm signals and information signals | 2023-03-30 | |
MED | ISO 80601-2-13:2011 | 201.11.8.102 Alarm Condition for Power Supply Failure201.12.4.103.1 Carbon dioxide MONITORING EQUIPMENT201.12.4.103.2 Oxygen MONITORING EQUIPMENT201.12.4.103.3 Anaesthetic agent MONITORING EQUIPMENT201.12.4.104 Exhaled volume monitoring equipment201.102.10.1 Inspiratory and expiratory valves - Constructional requirements201.102.10.2 Opening pressure201.102.10.3 Pressure flow-rate characteristics201.102.10.4 Reverse flow rate and dislocation201.103.3.1.1 Anaesthetic gas scavenging system inlet pressure201.103.3.1.2 Induced flow rate201.103.3.1.3 Flow resistance201.103.3.1.4 Spillage to atmosphere201.103.3.1.5 Leakage201.103.3.2.1 Single Fault Condition - Pressure201.103.3.2.2 Induced flow rate201.103.3.2.3 Sub atmospheric pressure at the input of the receiving system201.104.2.2 Accuracy201.104.3 Vapour output during and after oxygen flush201.105.7.1 Expiratory pause201.105.7.2 Inspiratory pause201.105.8 Sub atmospheric pressure | 2023-03-30 | |
MED | ISO 80601-2-13:2011/AMD1:2015 | 201.11.8.102 Alarm Condition for Power Supply Failure201.12.4.103.1 Carbon dioxide MONITORING EQUIPMENT201.12.4.103.2 Oxygen MONITORING EQUIPMENT201.12.4.103.3 Anaesthetic agent MONITORING EQUIPMENT201.12.4.104 Exhaled volume monitoring equipment201.102.10.1 Inspiratory and expiratory valves - Constructional requirements201.102.10.2 Opening pressure201.102.10.3 Pressure flow-rate characteristics201.102.10.4 Reverse flow rate and dislocation201.103.3.1.1 Anaesthetic gas scavenging system inlet pressure201.103.3.1.2 Induced flow rate201.103.3.1.3 Flow resistance201.103.3.1.4 Spillage to atmosphere201.103.3.1.5 Leakage201.103.3.2.1 Single Fault Condition - Pressure201.103.3.2.2 Induced flow rate201.103.3.2.3 Sub atmospheric pressure at the input of the receiving system201.104.2.2 Accuracy201.104.3 Vapour output during and after oxygen flush201.105.7.1 Expiratory pause201.105.7.2 Inspiratory pause201.105.8 Sub atmospheric pressure | 2023-03-30 | |
MED | ISO 80601-2-13:2011/AMD2:2018 | 201.11.8.102 Alarm Condition for Power Supply Failure201.12.4.103.1 Carbon dioxide MONITORING EQUIPMENT201.12.4.103.2 Oxygen MONITORING EQUIPMENT201.12.4.103.3 Anaesthetic agent MONITORING EQUIPMENT201.12.4.104 Exhaled volume monitoring equipment201.102.10.1 Inspiratory and expiratory valves - Constructional requirements201.102.10.2 Opening pressure201.102.10.3 Pressure flow-rate characteristics201.102.10.4 Reverse flow rate and dislocation201.103.3.1.1 Anaesthetic gas scavenging system inlet pressure201.103.3.1.2 Induced flow rate201.103.3.1.3 Flow resistance201.103.3.1.4 Spillage to atmosphere201.103.3.1.5 Leakage201.103.3.2.1 Single Fault Condition - Pressure201.103.3.2.2 Induced flow rate201.103.3.2.3 Sub atmospheric pressure at the input of the receiving system201.104.2.2 Accuracy201.104.3 Vapour output during and after oxygen flush201.105.7.1 Expiratory pause201.105.7.2 Inspiratory pause201.105.8 Sub atmospheric pressure | 2023-03-30 |