Stryker Endoscopy
Stryker Endoscopy
| Address(es) |
|
| Website | Not available |
| Status | MEMBER |
| Acceptance date | 2021-02-16 |
Further information
Stage | Country | Name |
|---|---|---|
2 | Germany |
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 | Clause 4.11 Power inputClause 5.7 Humidity preconditioning treatmentClause 5.9.2 Accessible partClause 7.1.2 Legibility of markingsClause 7.1.3 Durability of markingsClause 8.4 limitation of voltage, current, or energyClause 8.6.4 Impedance and current-carrying capabilityClause 8.7 Leakage currentClause 8.8 InsulationClause 8.9 Creepage distances and Air clearanceClause 9.2 Hazards associated with moving partsClause 9.4 InstabilityClause 9.6.2 Acoustic energyClause 9.8 Hazards associated with support systemClause 11.1 Excessive temperatures in ME equipmentClause 11.6 Overflow, spillage, leakage, cleaning, disinfection and sterilization, and compatibilityClause 11.7 BiocompatibilityClause 11.8 Interruption of the power supply/supply mainsClause 12 Accuracy of controls and instruments and protection against hazardous outputsClause 13 Hazardous situation and fault conditionsClause 14 Programmable electrical medical systemClause 15 Construction of ME equipmentClause 16 ME systems | 2021-02-16 | |
MED | IEC 60601-1:2005/AMD1:2012 | Clause 4.11 Power inputClause 5.7 Humidity preconditioning treatmentClause 5.9.2 Accessible partClause 7.1.2 Legibility of markingsClause 7.1.3 Durability of markingsClause 8.4 limitation of voltage, current, or energyClause 8.6.4 Impedance and current-carrying capabilityClause 8.7 Leakage currentClause 8.8 InsulationClause 8.9 Creepage distances and Air clearanceClause 9.2 Hazards associated with moving partsClause 9.4 InstabilityClause 9.6.2 Acoustic energyClause 9.8 Hazards associated with support systemClause 11.1 Excessive temperatures in ME equipmentClause 11.6 Overflow, spillage, leakage, cleaning, disinfection and sterilization, and compatibilityClause 11.7 BiocompatibilityClause 11.8 Interruption of the power supply/supply mainsClause 12 Accuracy of controls and instruments and protection against hazardous outputsClause 13 Hazardous situation and fault conditionsClause 14 Programmable electrical medical systemClause 15 Construction of ME equipmentClause 16 ME systems | 2021-02-16 | |
MED | IEC 60601-1:2005/AMD2:2020 | Accepted clausesClause 4.11 Power inputClause 5.7 Humidity preconditioning treatmentClause 5.9.2 Accessible partClause 7.1.2 Legibility of markingsClause 7.1.3 Durability of markingsClause 8.4 limitation of voltage, current, or energyClause 8.6.4 Impedance and current-carryingcapabilityClause 8.7 Leakage currentClause 8.8 InsulationClause 8.9 Creepage distances and Air clearanceClause 9.2 Hazards associated with moving partsClause 9.4 InstabilityClause 9.6.2 Acoustic energyClause 9.8 Hazards associated with support systemClause 11.1 Excessive temperatures in ME equipmentClause 11.6 Overflow, spillage, leakage, cleaning,disinfection and sterilization, and compatibilityClause 11.7 BiocompatibilityClause 11.8 Interruption of the power supply/supplymainsClause 12 Accuracy of controls and instruments andprotection against hazardous outputsClause 13 Hazardous situation and fault conditionsClause 14 Programmable electrical medical systemClause 15 Construction of ME equipmentClause 16 ME systems | 2023-05-18 | |
MED | IEC 60601-2-2:2017 | Clause 201.4 General requirementsClause 201.7 ME equipment identification, marking and documentsClause 201.8 Protection against electrical hazardsClause 201.11 Protection against excessive temperatureClause 201.12 Accuracy of controls and instruments and protection against hazardous outputsClause 201.13 Hazardous situations and fault conditionsClause 201.15 Construction of ME equipment (except subclause 201.15.101 Neutrode electrodes) | 2021-02-16 | |
MED | IEC 60601-2-2:2017/AMD1:2023 | Accepted clausesClause 201.4 General requirementsClause 201.7 ME equipment identification, markingand documentsClause 201.8 Protection against electrical hazardsClause 201.11 Protection against excessivetemperatureClause 201.12 Accuracy of controls and instrumentsand protection against hazardous outputsClause 201.13 Hazardous situations and faultconditionsClause 201.15 Construction of ME equipment( except subclause 201.15.101Neutrode electrodes) | 2023-05-18 | |
MED | IEC 60601-2-18:2009 | Clause 201.4 General requirementsClause 201.7 ME equipment identification, marking and documentsClause 201.8 Protection against electrical hazardsClause 201.10 Protection against unwanted and excessive radiation hazardsClause 201.11 Protection against excessive temperatureClause 201.12 Accuracy of controls and instruments and protection against hazardous outputsClause 201.13 Hazardous situations and fault conditionsClause 201.15 Construction of ME equipment | 2021-02-16 |