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
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 Clause 15: Construction of Medical Electrical Equipment as per IEC 60601-1.
Let's get into the topic.
Clause 15 - Construction of Medical Electrical
Equipment
The Clause 15 of IEC 60601-1 states the requirements for Construction of Medical Electrical Equipment. The following are the Sub-Clauses.
Arrangements of controls and indicators of Medical Electrical Equipment
Serviceability
Mechanical strength
Medical Electrical Equipment components and general assembly
Mains Supply Transformers of Medical Electrical Equipment and
transformers providing separation
Let’s discuss in detail about Important requirements of above-mentioned Sub Clauses.
Serviceability:
The Parts of Medical Electrical Equipment which are likely to be
replaced or adjusted due to electrical, mechanical wear and environmental
degradation or ageing shall be located and secured in an appropriate position
which allows inspection, servicing, replacement and adjustment without damage
to the nearby parts or wiring.
Mechanical Strength:
The Medical Electrical Equipment or its parts shall have an adequate mechanical strength which prevents it from having a loss of basic safety and essential performance. The adequacy of Mechanical strength is determined by the application of following tests based on the Medical Electrical Equipment Type.
Hand-Held Type
Push Test
Drop Test
Molding stress relief Test
Body Worn & Portable Type
Push Test
Impact Test
Drop Test
Molding stress relief Test
Mobile Type
Push Test
Impact Test
Rough handling Test
Molding stress relief Test
Fixed or Stationary Type
Push Test
Impact Test
Molding stress relief Test
Medical Electrical Equipment components and general
assembly:
Construction of connectors
The Connectors of Medical Electrical Equipment shall be designed in such a way that the incorrect connection of accessible connectors and the removal of connectors without the use of tool shall be prevented.
Temperature and overload control devices
Over current releases and thermal cuts outs shall be independent and
non-Self resetting.
Batteries
The incorrect polarity of the battery connection shall be prevented. The
housing of the battery shall be properly ventilated to allow gases which
produced due to charging and discharging of batteries to pass through.
Indicator
There shall be indicator lights to indicate that the Medical Electrical
Equipment is ready for normal use. There shall be an indicator to indicate that
the output exists for the Medical Electrical Equipment, in cases where the
accidental or prolonged operation of output circuit might lead to a hazardous
situation.
Actuating parts of controls of Medical Electrical Equipment
All actuating parts of the Medical Electrical Equipment shall be
adequately secured such that they cannot work loose or pulled off during the
normal use. All rotating or movable parts of controls in Medical Electrical
Equipment shall be provided with stops of adequate mechanical strength to
prevent it changing from Maximum controlled parameter to Minimum controlled
parameter or vice versa.
Cord-connected Hand-Held and foot-operated control devices
When placed in an abnormal position, the Hand-Held and foot-operated
control devices shall not present any unacceptable risk due to change in their
controlled settings. The foot operated control devices shall be designed in a
manner to support and withstand the weight of a adult human.
Mains Supply Transformers of Medical Electrical Equipment
and transformers providing separation:
In the event of short circuit or overload of any output winding, the
transformers of Medical Electrical Equipment shall be protected from Short
Circuit & Overload. The transformers shall undergo short circuit Test,
Overload Test & Dielectric Strength test as per the requirements of IEC
60601-1.
Now I hope you have acquired some knowledge about IEC 60601-1 Clause 15: Construction of 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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