50 degrees C Temperature Limit for Patient Use Medical Device

C

CaliforniaMike

#1
Hello,
We are working on a product that will be taken home and worn by pateints continuousally. My concern is that it appears to be impossible to comply with the safe temperature limits of IEC EN 60601.

The basic concern is the limit of 50C for a patient contact device. However, temperatures in California and Arizona exceed this temperature from time to time. Further, a device left in a car or in the sun will exceed this temperature pretty reguarly. For this reason, any temperature rise for a device used outside technically fails.

Am I missing some exclusion for ambient temperature or some maximum temperature rise caused by the device as opposed to the environment?

Thanks,

Mike
 
Elsmar Forum Sponsor

Peter Selvey

Staff member
Super Moderator
#2
Re: 50C temperature limit for patient use device

The temperature limits in the 3rd edition are greatly improved, but the test methods are not. Although not stated in the standard, it is expected that temperatures of applied parts will be taken in open air, and using the room as a reference ambient, both of which are not representative of the actual situation.

In practice, the applied part temperature will be a temperature rise above skin temperature (for external use) or body temperature (for internal use). The body can also cool the device.

The best guide can probably be taken from IEC 60601-2-37 (ultrasound), which for external use assumes a body temperature of 33C and allows up to 10C rise (total temperature of 43C). It uses a tissue mimicking material to represent cooling by the body. However, the limit is perhaps higher due to short term use.

For long term use, I would probably look at a temperature rise of 6C to be safe. If in open air, your equipment shows a temperature rise of 6C or less, then it's clear that when worn on the body it will also be safe. If the temperature rise exceeds 6C, then you might need tests on volunteers. But a typical battery operated device has negligible temperature rise.
 
C

CaliforniaMike

#3
Re: 50C temperature limit for patient use device

Peter,
Thank you very much for the help on this. A temperature rise releative to skin temperature does make sense. I will use this as a basis.

Thanks,

Mike
 
Thread starter Similar threads Forum Replies Date
S Primary Temperature Standard to -65 degrees C - Calibration Help General Measurement Device and Calibration Topics 3
G Glass scale calibration at 74 degrees F? General Measurement Device and Calibration Topics 4
G What degrees of freedom means in uncertainty budget and how do I set the value Measurement Uncertainty (MU) 2
G Calculating Tolerance of a Panel Meter with a 2 degrees of an Arc General Measurement Device and Calibration Topics 0
M Bachelor Degrees in Quality Management or Quality Assurance Career and Occupation Discussions 3
M Degrees of freedom for XmR charts Statistical Analysis Tools, Techniques and SPC 5
F How to convert inches to degrees - Inspecting the perpendicularity of 2 lines Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
T Customer Escape of a part having features reversed 180 degrees Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
E Online Degrees and Graduate Certificates in Statistics Training - Internal, External, Online and Distance Learning 1
C Degrees of Freedom with Linear Regression - Pressure Sensor Uncertainty Measurement Uncertainty (MU) 15
C Design Change needed for Changing an Angle in existing Product from 15-25 degrees? ISO 13485:2016 - Medical Device Quality Management Systems 11
N The Worth and Value of Certifications and Degrees Career and Occupation Discussions 15
S Degrees of Freedom - How to calculate degrees of freedom and bias General Measurement Device and Calibration Topics 3
P Minitab error: Zero or negative degrees of freedom Using Minitab Software 16
N Calculating Degrees of Freedom in order to determine my K value Measurement Uncertainty (MU) 4
S Degrees of freedom in a 2 sample t test Six Sigma 5
Marc Online Degrees from Thunderwood College Funny Stuff - Jokes and Humour 18
R How would you explain DoF (Degrees of Freedom) to a non-statistician? Statistical Analysis Tools, Techniques and SPC 3
C Conversions - Decimal degrees into thousands - CMM that measures an angle Inspection, Prints (Drawings), Testing, Sampling and Related Topics 22
R Which reputable colleges/universities offer online undergraduate College degrees? Professional Certifications and Degrees 6
M Do any of the top Universities offer online degrees? Training - Internal, External, Online and Distance Learning 11
A Measurement Uncertainty (MU) - Confidence Interval & Degrees of Freedom? Measurement Uncertainty (MU) 4
S MiniTab vs. Excel: Difference in Degrees of Freedom Excel .xls Spreadsheet Templates and Tools 5
J Engineer or Not? How many people have engineering degrees? Career and Occupation Discussions 156
A Where can I find Duncan's Tables (d2* and Degrees of Freedom) on the internet? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
Judy Abbott General temperature used in the blasting process and laser process Manufacturing and Related Processes 2
R IEC 60601-1 - 11.1.3 e) Test criteria - Temperature Measurements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
T Temperature Requirements For In House Calibration - AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
C One Time Service Supplier - Temperature and Humidity Testing Service ISO 13485:2016 - Medical Device Quality Management Systems 5
R SAT (System Accuracy Test) temperature according to AMS2750E AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
W Insulation requirements of BF type infant skin temperature probe IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
B Temperature loop: partial calibration General Measurement Device and Calibration Topics 10
D ASTM C1064 Temperature Measuring Device General Measurement Device and Calibration Topics 2
C ETO Sterilised Class II Medical Device - Required Temperature Storage ISO 13485:2016 - Medical Device Quality Management Systems 1
M Microscope slide warmer temperature control General Measurement Device and Calibration Topics 4
S ISO 18223-2 Temperature symbol in the Legend table in the Instructions for Use Other ISO and International Standards and European Regulations 4
B ASTM F2924-14 /ASTM F3001 - Room temperature classification criteria Other US Medical Device Regulations 0
O Selection of a calibrator (pressure generator, temperature) for my field devices General Measurement Device and Calibration Topics 2
shimonv Symbol for temperature limit EU Medical Device Regulations 6
M Pharmaceuticals Warehouse temperature control (room temperature) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
T 5ºC Storage Temperature Validation - Urology disposable devices EU Medical Device Regulations 3
Q Weigh Scale Electronics - Suggested Storage Humidity and Temperature Manufacturing and Related Processes 7
M CQI-9 monitoring of temperature in die Various Other Specifications, Standards, and related Requirements 2
C ISO 11607-1 Packaging System - Temperature and shipping conditioning Other Medical Device Related Standards 4
G Calibration Laboratory Dimensional Temperature Question General Measurement Device and Calibration Topics 2
V Temperature/humidity requirements in internal metrology laboratory General Measurement Device and Calibration Topics 3
P Qualification of a Temperature Controlled Unit have to be empty? Qualification and Validation (including 21 CFR Part 11) 5
D What is the exact Temperature Coefficient Value to be set on a Conductivity Meter? General Measurement Device and Calibration Topics 2
K Temperature Uniformity Survey (TUS) - Vacuum Furnace General Measurement Device and Calibration Topics 1
R Saudi Arabia - Temperature Storage Requirements Other Medical Device Regulations World-Wide 4

Similar threads

Top Bottom