Mains fuses and OVER-CURRENT RELEASES

#1
8.11.5 * Mains fuses and OVER-CURRENT RELEASES
A fuse or OVER-CURRENT RELEASE shall be provided in each supply lead for CLASS I ME EQUIPMENT and for CLASS II ME EQUIPMENT having a functional earth connection according to

8.6.9, and in at least one supply lead for other single-phase CLASS II ME EQUIPMENT, except that:
– for PERMANENTLY INSTALLED ME EQUIPMENT, the neutral conductor shall not be fused;
– if examination shows that two MEANS OF PROTECTION are present between all parts of opposite polarity within the MAINS PART, and between all parts of the MAINS PART and earth, then the fuses or OVER-CURRENT RELEASES may be omitted. These insulation requirements shall be continued up to and within any component. The effect of short-circuit fault
conditions in other circuits shall be considered before eliminating fuses or OVER-CURRENT RELEASES.

A PROTECTIVE EARTH CONDUCTOR shall not incorporate a fuse or OVER-CURRENT RELEASE.

Protective devices shall have adequate breaking capacity to interrupt the maximum fault current (including short-circuit current) which can flow.


For our Class 1 device (which is a 110-120V 50/60Hz 1100W blower) we are adding a fuse holder with a F, 12A, 10kA, 125V fuse on the hot wire. In the literature it makes it sound like we would have to add a fuse to the neutral wire which seems absolutely pointless. I asked a safety reviewer at the company we are going to get our device tested and he said "A over current device has to provide in each supply lead (the line & neutral conductors)". How could we possibly bypass this and have a fuse just on the hotwire or is there no way to bypass this?
 
Elsmar Forum Sponsor

Ninja

Looking for Reality
Trusted Information Resource
#2
– for PERMANENTLY INSTALLED ME EQUIPMENT, the neutral conductor shall not be fused;

– if examination shows that two MEANS OF PROTECTION are present between all parts of opposite polarity within the MAINS PART, and between all parts of the MAINS PART and earth, then the fuses or OVER-CURRENT RELEASES may be omitted.
I am not in medical equipment.

That said...more info needed...

Is your equipment permanently installed?
If not, what are your two means of protection?

If the answer is "no" and "we have only one"...the answer seems sorta clear...
 

3dBUnderThe Limit

Starting to get Involved
#3
I think that the point is that unless you have a fixed installation you don't know what wire in your equipment is "hot" => fuses in both leads for a Class I Medical Device. (unless 2 MOP "everywhere").
 
Thread starter Similar threads Forum Replies Date
P Fuse Agency Approvals - Fuses without VDE / IEC Approvals on AC Mains Lines IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
J Application of mains voltage on SIP/SOP connectors of medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
L Allowable AC mains fuse types for latest IEC60601 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
V 2MOP of mains voltage is required between 2nd Circuity and Accessible parts? IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
S Mains outlet MSO definition IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
F SIP/SOP - Mains Power and Medical Device Ethernet Ports IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
R Hospital Grade Mains Plug US (NEMA 5-15) and Japan IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
K Why two fuses are required - IEC 60601-1 cl. 8.11.5 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D EN60601-1 - Resettable fuses in a ME-device IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
R Fuses that in series with each supply lead are only housed by Heat Shrink Tubing IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
K Using a Circuit Breaker instead of Fuses in Medical Equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
S About the rating of fuse - Can I employ 2 fuses of different rating in my equipment? IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
W Regarding Requirement for Hi pot & Leakage Current test Station Set-up IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
S Forced ServiceNow validation - No change in our current user and functional requirements IT (Information Technology) Service Management 6
W Need for current design or process control FMEA and Control Plans 2
A Earth leakage current test for Permanently installed Large scale MEE IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
E Best way to keep up with pharmaceutical quality knowledge and current affairs Service Industry Specific Topics 1
T Iec 60601 Impedance and current-carrying capability IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Informational TGA – Current status of breast implant products in Australia Medical Device and FDA Regulations and Standards News 0
F Proficiency Testing for ISO 17025: AC Current Ranges ISO 17025 related Discussions 1
A Touch current in single fault conditions test and earth leakage current in normal conditions test, are they really different tests? IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
T Tests IEC 60601-1 - Grounding Resistance, Leakage Current and Dielectric Rigidity in an automated way IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S Calibration - Isolated current meter - Measuring patient auxiliary leakage current Calibration and Metrology Software and Hardware 4
Q Raising A CAPA on Current CAPA system US Food and Drug Administration (FDA) 3
A SPC for Eddy Current Testing Statistical Analysis Tools, Techniques and SPC 28
A Adding Remote Site to Current IATF 16949 Certification IATF 16949 - Automotive Quality Systems Standard 2
S Leakage Current test and Dielectric strength for Battery operated ECG device? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
M Leakage current measurement with non-frequency-weighted device IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A QMS - Medical Device - New company under a current one ISO 13485:2016 - Medical Device Quality Management Systems 3
E IEC 60335-1 leakage current measurement Other ISO and International Standards and European Regulations 3
K Questions on Technical File to show it is current EU Medical Device Regulations 5
H IS there any database for list of CE marked Medical devices and there current status EU Medical Device Regulations 8
P Adding an additional distributor to a current Mexico Medical Device Registration Other Medical Device Regulations World-Wide 0
M IEC 60601-1 and Active Current Protection Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
M Testing a Low Current (Battery) DC Medical Device Other Medical Device Related Standards 4
D Referencing Standards in Procedures - Current version or actual? Document Control Systems, Procedures, Forms and Templates 6
I Curious if a List of Current Standards Revisions Exsists Other Medical Device Related Standards 3
C Touch Current for Exposed Charging Contacts on Bodyworn Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R Current version of EN62304/A1 IEC 62304 - Medical Device Software Life Cycle Processes 5
A Power Traceability certificate for values for voltage, current and phase General Measurement Device and Calibration Topics 1
Q What constitutes current technical data? Federal Aviation Administration (FAA) Standards and Requirements 2
M Current standard references IEC 60601:1988 instead of current version EU Medical Device Regulations 5
K What are the current ISO/ TS 16949 Semiconductor Manufacturer Requirements IATF 16949 - Automotive Quality Systems Standard 12
G How to cover another manufacturing "site" or warehouse into current ISO 13485 cert ISO 13485:2016 - Medical Device Quality Management Systems 7
P Document references need to be updated to correspond to the current year? Document Control Systems, Procedures, Forms and Templates 5
P Humidity Pre-Conditioning before leakage current and dielectric strength tests IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
Gman2 The current state of our Calibration System General Measurement Device and Calibration Topics 28
R Is EN/IEC 60417 still current? Other Medical Device Related Standards 4
R New Draft Guidance Document for FDA's current thinking on De Novo submission Other US Medical Device Regulations 1
W How can I test the Patient Leakage Current of an Infusion Pump? IEC 60601 - Medical Electrical Equipment Safety Standards Series 9

Similar threads

Top Bottom