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13-12
Chapter 13 Appendix
Example of Combinations of Medical
Devices and Non-Medical Devices
Below is an overview of situations that may be created when combinations of different devices described in IEC 60601-1:
"General Requirements for Medical Electrical Systems" are used in different medical environments.
Systems used in patient environment must contain safety features equivalent to medical devices that comply with IEC 60601-1.
Systems used outside the patient environment must contain safety features equivalent to non-medical devices that comply with
other IEC standards. IEC 60601-1 states that in the case of non-medical devices outside the patient environment, it is sufficient
to ensure that the safety features comply with the applicable technical standard under IEC or the Electrical Appliance and
Material Safety Act, or are equivalent to such features. (*1).
When building a medical electrical system, assuming that this device is device A, device B should be installed as shown below.
Patient Environment
Outside
Patient Environment
Room Used for Other
Purposes than
Medical Examination
B
Proven
System Safety
Common protective grounding
B
IEC 60601
A
Medical
Equipment
IEC 60601
B
IEC 60601
B
Proven
IEC XXXXX (*
1
)
System Safety
A
Medical
Equipment
IEC 60601
A
Medical
Equipment
IEC 60601
IEC XXXXX (*
1
)
A
Medical
Equipment
IEC 60601
Содержание VaSera VS-2000 Series
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Страница 134: ...6 10 Chapter 6 Blood Pressure and Pulse Wave Examination Simple Mode ...
Страница 140: ...7 6 Chapter 7 Blood Pressure and Pulse Wave Examinations Other Functions ...
Страница 172: ...9 22 Chapter 9 File Transfers Communication History ...
Страница 176: ...10 4 Chapter 10 Recording Daily Reports ...
Страница 214: ...12 12 Chapter 12 Maintenance and Inspection ...
Страница 233: ...The company and product names used in this manual are trademarks or registered trademarks of respective companies ...