Stryker Instruments
Stryker Instruments
Address(es) |
|
Website | Not available |
Status | MEMBER |
Acceptance date | 2021-03-26 |
Further information
Stage | Country | Name |
---|---|---|
2 | United States of America |
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 | Cl. 5.7 – Humidity ConditioningCl. 5.9.2 – Determination of Accessible PartsCl. 7.1.2 – Legibility of MarkingsCl. 7.1.3 – Durability of MarkingsCl. 8.7 – Leakage CurrentCl. 8.7.4.6 – Touch Leakage CurrentCl. 8.7.4.7 a) – Patient Leakage CurrentCl. 8.7.4.7 b) – Patient Leakage Current, Mains on F-Type APCl. 8.7.4.7 d) – Patient Leakage Current, Mains on Non-PE EnclosureCl. 8.7.3 e) – Non-Frequency-Weighted Leakage CurrentCl. 8.8.3 – Dielectric Voltage WithstandCL. 8.8.4.1 – Ball PressureCl. 9.4.2 – Stability and TransportabilityCl. 9.6.3 – Hand Transmitted VibrationCl. 11 – TemperatureCl. 11.6.6 – Cleaning and DisinfectionCl. 11.6.7 – SterilizationCl. 11.8 – Interruption of Power SupplyCl. 13 – Abnormal Operation TestingCl. 13.2 – Locking of Moving PartsCl. 15.3.2 – Enclosure ForceCl. 15.3.4 – Drop ImpactCl. 15.3.6 – Mold Stress Relief Test | 2021-03-26 | |
MED | IEC 60601-1:2005/AMD1:2012 | Cl. 5.7 – Humidity ConditioningCl. 5.9.2 – Determination of Accessible PartsCl. 7.1.2 – Legibility of MarkingsCl. 7.1.3 – Durability of MarkingsCl. 8.7 – Leakage CurrentCl. 8.7.4.6 – Touch Leakage CurrentCl. 8.7.4.7 a) – Patient Leakage CurrentCl. 8.7.4.7 b) – Patient Leakage Current, Mains on F-Type APCl. 8.7.4.7 d) – Patient Leakage Current, Mains on Non-PE EnclosureCl. 8.7.3 e) – Non-Frequency-Weighted Leakage CurrentCl. 8.8.3 – Dielectric Voltage WithstandCL. 8.8.4.1 – Ball PressureCl. 9.4.2 – Stability and TransportabilityCl. 9.6.3 – Hand Transmitted VibrationCl. 11 – TemperatureCl. 11.6.6 – Cleaning and DisinfectionCl. 11.6.7 – SterilizationCl. 11.8 – Interruption of Power SupplyCl. 13 – Abnormal Operation TestingCl. 13.2 – Locking of Moving PartsCl. 15.3.2 – Enclosure ForceCl. 15.3.4 – Drop ImpactCl. 15.3.6 – Mold Stress Relief Test | 2021-03-26 | |
MED | IEC 60601-1:2005/AMD2:2020 | Cl. 5.7 – Humidity ConditioningCl. 5.9.2 – Determination of Accessible PartsCl. 7.1.2 – Legibility of MarkingsCl. 7.1.3 – Durability of MarkingsCl. 8.7 – Leakage CurrentCl. 8.7.4.6 – Touch Leakage CurrentCl. 8.7.4.7 a) – Patient Leakage CurrentCl. 8.7.4.7 b) – Patient Leakage Current, Mains on F-Type APCl. 8.7.4.7 d) – Patient Leakage Current, Mains on Non-PE EnclosureCl. 8.7.3 e) – Non-Frequency-Weighted Leakage CurrentCl. 8.8.3 – Dielectric Voltage WithstandCL. 8.8.4.1 – Ball PressureCl. 9.4.2 – Stability and TransportabilityCl. 9.6.3 – Hand Transmitted VibrationCl. 11 – TemperatureCl. 11.6.6 – Cleaning and DisinfectionCl. 11.6.7 – SterilizationCl. 11.8 – Interruption of Power SupplyCl. 13 – Abnormal Operation TestingCl. 13.2 – Locking of Moving PartsCl. 15.3.2 – Enclosure ForceCl. 15.3.4 – Drop ImpactCl. 15.3.6 – Mold Stress Relief Test | 2022-06-21 |