SBS - The Best Value in QMS software

IEC 60601-1 - 11.1.3 e) Test criteria - Temperature Measurements

#1
Hello,
I have question on temperature monitoring test of 60601-1
11.1.3 e) Test criteria :
The maximum temperature of a part is determined by measuring the temperature rise of the part under test and adding it to the maximum allowed ambient temperature specified in the technical description (see 7.9.3.1).

In technical description operating temperature range is 10 to 50 degree specify. So max temp is 50 degree.
At a time of temperature measurement I tested the applied part temperature increase on 4 degree then we have to add the 4 degree on max operating temp range i.e 50 then maximum temperature of a applied part is 54 degree. As per table 24 on 60601-1 applied part temp is 43 degree then how can i concluded on that. Please help me.
1604135533198.png

Regards
Roshan
 
Elsmar Forum Sponsor

Peter Selvey

Staff member
Super Moderator
#2
This is a problem or mistake in the general standard.

You can use IEC 60601-2-37 for ultrasounds as a reference. From memory (I haven't checked lately), they assume 35°C base (typical skin/surface temperature) and have a limit of 41°C. Also they allow that the body may cool the part. You can do a test in open air and measure the temperature rise is less than 6K then the result is OK, or if it is above 6K then test with a simulated body material. Usually the result is less than 6K so it's easy pass.
If the part is intended to apply internally, the reference should be 37°C and the limit is 4K rise.

Since it is going against the standard, the manufacturer can write this up in risk management as an alternate solution. But, I think it's such an obvious mistake that a test lab can also reasonably judge it is OK without risk management.

Most equipment is rated for 0-40°C operating. So that would mean any applied part with a >1K temp rise needs clinical justification. Which is crazy.
 
#3
Dear Peter,
Thank you for reply. If manufacture gives the justification in risk management on temperature of applied part , so can we accept .
Means manufacture disclosed the max temp of applied part in risk management file and in the instructions for use.
 
Thread starter Similar threads Forum Replies Date
C IEC 60601 - 8.8.3 Dielectric Strength test. 4kv being applied to the ground conductor?! IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R IEC 60601-1 Clause 15.3.2, Push test IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
A Defining a lower ESD test level in IEC 60601 safety test IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
M Is it normal / sufficient to have only the IEC 60601-1-2 test report without indicating IEC 60601-1? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
Z IEC 60601-2-25; Frequency response test Medical Device and FDA Regulations and Standards News 1
N IEC 60601-1-1 - Stress test, reference voltage IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A IEC 60601-1 Dielectric Strength test for battery operated devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
JoCam Failure to test Class I medical device to IEC 60601-1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
K Dielectric strength test as per IEC 60601-1 -Infant incubator IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
G Is impact test according to IEC 60601-1 applicable for HAND-HELD equipment if also classified as BODY-WORN? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A IEC 60601-2-2 - Defib-proof test amendment to base standard IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
K Electromagnetic Compatibility Test IEC 60601-1-2: 2014 IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
A IEC 60601-1 Impact test on glass touch controller IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S IEC 60601-1-2 Radiated Immunity Test - Diagnostic ECG device IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S IEC 60601-1 Humidity Precondition Test IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
S IEC 60601-1-2 immunity to proximity fields Test setup - Diagnostic ECG device IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S IEC 60601-1-2 - RF Conducted Immunity Test Setup - Diagnostic ECG device IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
S IEC 60601-1 Electrical safety testing - Dielectric Strength Test - 8.8.3 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
Ed Panek Transition to IEC 60601 4th Edition - Risk Analysis and test submissions CE Marking (Conformité Européene) / CB Scheme 2
O IEC 60601-1-2:2014 Test plan guidance CE Marking (Conformité Européene) / CB Scheme 2
D IEC 60601 Defibrillation protection test - Metal foil IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
O Suggestions for templates for formulating test plan for IEC 60601-1-2 4th ed CE Marking (Conformité Européene) / CB Scheme 0
F Test Equipment for IEC 60601-2-27 related to the picture 201.105 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
X Neutral Electrode IEC 60601-2-1 Test House IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M 15.3.3 Ball Impact Test requirements in IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
O Determination of Test Cycles of Dynamic Forces (IEC 60601) IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A What kind of test is described in subclause 56.3(c) of IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
C EMC Test Report Requirements to IEC 60601-1-2:2009 ISO 13485:2016 - Medical Device Quality Management Systems 4
S IEC 60601-1 Cl. 14 - Report changes in Software after Testing to Test Lab? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
T Need to repeat IEC 60601-1-2 test agains ed3.0 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S IEC 60601-1 (Cl.15.3.6) Mould Stress Relief Test IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
J IEC 60601 (Steel Ball Impact Test) Other ISO and International Standards and European Regulations 1
C INMETRO 350 Dielectric Strength Test to IEC 60601-1 clauses 18, 19 and 20 Other Medical Device Regulations World-Wide 5
C An ongoing EMC test in accordance with IEC/EN 60601-2-47 EMC IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
A IEC 60601 Ground Bond Test Requirements for a Plastic Enclosure IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
N RS485 stand to meet the EFT (Electrical Fast Transients) test according to IEC 60601 ISO 13485:2016 - Medical Device Quality Management Systems 3
Z CB Certificate and IEC 60601-1 Test Report requirements - Korea Product Registration Other Medical Device Regulations World-Wide 6
I Dielectric Test for HF Surgical Equipment (IEC 60601-2-2 clause 201.8.5.1.2) IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A AC Adapter change from IEC 60601-1-2 test IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M Current Products on the Market and IEC 60601 3rd Edition Safety Re-Test Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
S Protective Earth Test in IEC 60601 IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
B IEC 60601 3rd Edition - Test Report Form UL uses for testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
L Top opening of enclsoure against fire in IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
C EN 45502 vs IEC 60601-1-8 Other Medical Device Related Standards 0
JoCam IEC 60601-1 and 60601-1-2 retest after PCBA change IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
K IEC 60601-1:2005/AMD2:2020, Why this standard version is 3.0? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
J IEC 60601-1-11 Home Class II With Ballasts IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A Coverage and differences: EN 60601-1:2006+A12:2014 Vs AAMI/IEC 60601-1:2005+AMD1:2012 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
T IEC 60601-1-8:2020 Is it necessary to change the alarm melody? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
S IEC 60601-2-30 - Is it mandatory to claim alarms? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1

Similar threads

Top Bottom