MOOP and insulation coordination

P

petruchio

#1
#1
IEC 60601-1 clause 8.5.1.3 states that solid insulation shall comply with the dielectric strength test OR comply with insulation coordination requirements per IEC 60664-4 (not per IEC 60950-1 as printed).

I find IEC 60664-4 is very difficult to understand so could anyone summarise the requirements which must be complied with in order to avoid performing dielectric strength tests.

Thanks.

Doug (aka petruchio)
Cambridge UK
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
P

Peter Selvey

Staff member
Moderator
#3
#3
The standard refers to IEC 60950, not IEC 60664-1.

In principle the standard is saying that the designer can choose to comply with the requirements in IEC 60601-1 or IEC 60950 for operator parts.

This is a major change in the 3rd edition, and is intended to allow the use of cheaper parts such as 950 power supplies to be used in medical equipment, as long as the insulation only affects the operator, not the patient.

In practice, the designer can select a 950 certified part, which would allow them to skip 601 assessment. If the part is not certified to 950, then it makes sense to test according to 601. The requirements in 601 for operator protection are mostly harmonized with 950, logistically it makes sense to use 601 requirements for uncertified parts, rather than trying to work with 2 standards for no benefit.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
B Accessible parts per 8.4.2 b) - Touch currents in combination with MOOP or MOPP? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S IEC 60601-1 - MOPP and MOOP Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
P 2x MOOP for type B AP - Therapeutic device - Heater/cooler with pump IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
G Creepage and Clearance Distance for MOOP on Secondary Circuit IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Can I continue using IEC60601-1 Ed2 PSU for MOOP (Means Of Operator Protection) IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
K Doubt on insulation class of a device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
W Insulation requirements of BF type infant skin temperature probe IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
M 2xMOPP insulation for Applied Part B. IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
Q Isolation/Insulation Diagrams - IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
V PCB internal insulation treated as insulation formed by insulating compound IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
W HF surgery device accessory insulation requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
E Creepage distance accross insulation of step up transformer EU Medical Device Regulations 2
S Who compiles the Critical Component List, Insulation Diagram etc.? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
P Question on Table 6 "Test voltages for solid insulation forming a MEANS OF PROTECTION IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K IEC60601 3rd Edition Insulation Thickness for electrosurgical devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
N Cable Connectors - Insulation does not go all the way into the back of the connector Manufacturing and Related Processes 4
A Insulation between Secondary Accessible Parts and Earth IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
P IEC 60601-1-11 - Conversion to Double Insulation IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R Is insulation between F type applied part and other parts a must? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
N Insulation Diagram for Water Tub IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
W Is anybody familiar with IEC61010-1 Insulation Requirements? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
V External power supply with reinforced insulation as a simple secondary circuit? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
W Insulation requirements between F-type applied part and enclosure IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
P Understanding IEC 60601-1:2005, Clause 8.1 b) - Short Circuiting Double Insulation IEC 60601 - Medical Electrical Equipment Safety Standards Series 13
R Determining Working Voltage - Drawing a Medical Device Insulation Diagram IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
W Insulation Grade for In Vitro Diagnostic (IVD) Device? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S Do insulation layers in double insulation have sequence requirement? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
S Can enclosure of semiconductor or electrolytic capacitor provides basic insulation? IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
N Insulation Barrier Testing - According IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 22
T Insulation diagram for a medical electrical equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
H Insulation of FRP (fiberglass reinforced plastic) Tanks Manufacturing and Related Processes 3
B Control Chart - Minimum point & average insulation thickness for Automotive Wires Statistical Analysis Tools, Techniques and SPC 9
A Medical device with NON medical PC - USB galvanic insulation ISO 13485:2016 - Medical Device Quality Management Systems 2
M Informational Next meeting of the Medical Device Coordination Group (MDR/IVDR) – 20 June 2019 Medical Device and FDA Regulations and Standards News 2
V NESCC (Nuclear Energy Standards Coordination Collaborative) participants here? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 2
K New AS9101 - The Coordination Draft. Not the Official Release - IAQG9101 standard AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 76

Similar threads

Top Bottom