Hi friends!!!
In our previous blogs, we have discussed about the following topics.
IEC 60601-1 Classification of Medical Electrical Equipment
IEC 60601-1 General Requirements for Testing Medical Electrical Equipment
IEC 60601-1 Medical Electrical Systems
IEC 60601-1 Protection against unwanted and excessive radiation hazards
IEC 60601-1 General Requirements
IEC 60601-1 Programmable Electrical Medical Systems
IEC 60601-1 Hazardous situations and fault condition
IEC 60601-1 Construction of Medical Electrical Equipment
IEC 60601-1 Leakage Currents and Patient Auxiliary Currents
IEC 60601-1 Creepage Distance and Air Clearance
IEC 60601-1 Components and Wiring
IEC 60601-1 Mechanical Hazards Moving Parts
EU MDR Timeline, Annex, Chapter
EU MDR Post Market Surveillance
EU MDR Technical Documentation - Part 1
EU MDR Technical Documentation - Part 2
EU MDR General Safety and Performance Requirement
EU MDR Information on the Label
EU MDR Post Market Clinical Follow Up
EU MDR Unique Device Identification - Part 1
EU MDR Unique Device Identification - Part 2
EU MDR Chapter & Articles - Part 1
EU MDR Chapter & Articles - Part 2
In today's blog, we are going to discuss about IEC 60601-1.
IEC 60601-1 states the Basic safety requirements for Medical Electrical Equipment's. Satisfying the requirements of IEC 60601-1 is an important task in order to commercialize the Medical Electrical Equipment's
Therefore, it is important for Medical Device QA/RA Professionals to know in detail about Sub Clause 11.1: Excessive temperatures in Medical Electrical Equipment as per IEC 60601-1.
Let's get into the topic.
Excessive Temperatures in Medical Electrical
Equipment:
Maximum Temperature during Normal Use:
When the Medical Electrical Equipment is being operated in Worst
case normal use condition, including maximum ambient temperatures, the Medical
Electrical Equipment shall not reach temperatures mentioned in table 22 and
table 23 of IEC 60601-1.
The temperatures at the surfaces of the test corners in the
Medical Electrical Equipment shall not exceed 90°C.
The Thermal cut-outs shall not be used in normal condition.
Temperature of Applied Parts:
Applied Parts intended to supply heat to a patient:
The Risk Management File shall document the temperatures of hot or
cold surfaces and its clinical effects where it’s appropriate.
Applied Parts not intended to supply heat to a patient:
If the surface temperatures at the applied parts of the Medical
Electrical Equipment reaches above 41°C, the maximum temperatures attained shall be disclosed in the
instructions for use.
The conditions for safe contacts such as but not limited to
duration or condition of the patient shall be disclosed.
The Clinical effects with respect to different characteristics
such as but not limited to body surface, maturity of patients shall be
determined and documented in risk management file.
No justification is required, if the surface temperatures of the
applied parts does not exceed 41°C
Measurements:
When the manufacturer provides the engineering judgement stating
that the temperatures shall not exceed, then no measurement shall be required.
The Medical Electrical Equipment shall be tested in the position
of its normal use.
During testing, The Medical Electrical Equipment having heating
elements shall be operated as like in the normal use. All the heating elements
shall be energized unless prevented by switching interlocks. The Supply voltage
shall be equal to 100% of maximum rated voltage.
During testing, The Medical Electrical Equipment operated by motor
shall be operated in its normal load and normal duty cycle. The motor shall be
tested in least favourable voltage between 90% of the maximum rated voltage and
110% of the maximum rated voltage.
The Medical Electrical Equipment operated by the combination of
both heating elements and motor shall be tested both at 90% of maximum rated
voltage and 110% of maximum rated voltage.
For Medical Electrical Equipment operating in a non-continuous
operation, once attaining a thermal stability after operating in standby mode,
the medical electrical equipment shall be operated in normal use over
consecutive cycles until thermal stability is reached again.
For Medical Electrical Equipment operating in a continuous
operation, it shall be operated until thermal stability is reached.
The Temperature of windings shall be measured based on the
Resistance Method.
The Thermocouple and other methods shall be used for all other
measurements. The sensors and devices used for measurement shall be chosen and
positioned in such a manner that the sensors and devices can have negligible
effect on the temperature of the part under test.
The Temperature of electrical isolation other than windings shall
be measured on the surface of the isolation where short circuit can happen as a
result of failure.
Now I hope you have acquired some knowledge about IEC 60601-1 Sub Clause 11.1: Excessive Temperatures in Medical Electrical Equipment. We will meet again with another valuable topic related to Biomedical Engineering, Medical Device, Healthcare.
NOTE: Dear friends!!!... Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.
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