Elekta Limited
Elekta Limited
Address(es) |
|
Website | Not available |
Status | MEMBER |
Acceptance date | 2020-07-22 |
Further information
Stage | Country | Name |
---|---|---|
1 | United Kingdom |
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:5.7 - Humidity Preconditioning8.8.4.1 - Ball pressure test of thermoplastic parts8.9.4 - Thermal cycling test9.4.2.1 - Instability—overbalance in transport position9.4.2.2 - Instability—overbalance excluding transport position9.4.2.4.2 - Castors and wheels – Force for propulsion9.4.2.4.3 - Castors and wheels – Movement over a threshold9.4.3.1 - Instability from unwanted lateral movement (including sliding) in transport position 9.4.3.2- Instability from unwanted lateral movement (including sliding) excluding transport position 9.6.3 - Hand-transmitted vibration11.2.2 - Me equipment and me systems used in conjunction with OXYGEN RICH ENVIRONMENTS11.6.5 - Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS11.6.7 - Sterilization of ME EQUIPMENT and ME SYSTEMS13.2.11 - Failures of components in ME EQUIPMENT used in conjunction with OXYGEN RICH ENVIRONMENTS15.3.4.1 - Drop Test (hand-held)15.3.5 - Rough handling test15.3.6 - Mould Stress ReliefANNEX G - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANESTHETIC MIXTURESANNEX L - INSULATED WINDING WIRES FOR USE WITHOUT INTERLEAVED INSULATION | 2020-07-22 | |
MED | IEC 60601-1:2005/AMD1:2012 | All clauses except:5.7 - Humidity Preconditioning8.8.4.1 - Ball pressure test of thermoplastic parts8.9.4 - Thermal cycling test9.4.2.1 - Instability—overbalance in transport position9.4.2.2 - Instability—overbalance excluding transport position9.4.2.4.2 - Castors and wheels – Force for propulsion9.4.2.4.3 - Castors and wheels – Movement over a threshold9.4.3.1 - Instability from unwanted lateral movement (including sliding) in transport position 9.4.3.2- Instability from unwanted lateral movement (including sliding) excluding transport position 9.6.3 - Hand-transmitted vibration11.2.2 - Me equipment and me systems used in conjunction with OXYGEN RICH ENVIRONMENTS11.6.5 - Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS11.6.7 - Sterilization of ME EQUIPMENT and ME SYSTEMS13.2.11 - Failures of components in ME EQUIPMENT used in conjunction with OXYGEN RICH ENVIRONMENTS15.3.4.1 - Drop Test (hand-held)15.3.5 - Rough handling test15.3.6 - Mould Stress ReliefANNEX G - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANESTHETIC MIXTURESANNEX L - INSULATED WINDING WIRES FOR USE WITHOUT INTERLEAVED INSULATION | 2020-07-22 | |
MED | IEC 60601-2-1:2020 | Only the following clauses:201.9.2.4.101- Motors Emergency Stop Measured Disconnection Time201.9.2.101b - Powered Rotational Movements gantry and radiation head201.9.2.101b - Powered Linear Movements201.9.2.101c - Gantry and radiation head Powered Rotational Movements patient positioner201.9.2.101c - Powered Linear Movements patient positioner | 2025-01-31 | |
MED | IEC 60601-2-1:2009 | Accepted clauses:201.9.2.4.101 - MOTORS EMERGENCY STOP MEASURED DISCONNECTION TIME201.9.2.101a - POWERED ROTATIONAL MOVEMENTS201.9.2.101b - POWERED LINEAR MOVEMENTS | 2020-07-22 | |
MED | IEC 60601-2-1:2009/AMD1:2014 | Accepted clauses:201.9.2.4.101 - MOTORS EMERGENCY STOP MEASURED DISCONNECTION TIME201.9.2.101a - POWERED ROTATIONAL MOVEMENTS201.9.2.101b - POWERED LINEAR MOVEMENTS | 2020-07-22 | |
MED | IEC 60601-2-68:2014 | Accepted clauses:201.9.2.101 - POWERED ROTATIONAL MOVEMENTS / POWERED LINEAR MOVEMENTS | 2022-07-14 |