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
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 8.10: Components and Wiring as per IEC 60601-1.
Let's get into the topic.
Sub Clause 8.10: Components and Wiring
The Sub Clause 8.10 of IEC
60601-1 states the requirements for Components and Wiring. It is further
classified as following.
Fixing of Components
Fixing of Wiring
Connections between different
parts of Medical Electrical Equipment
Cord Connected Hand-Held parts
& Cord Connected foot operated control devices
Mechanical Protection of Wiring
Guiding rollers for Insulated
Conductors
Insulation of Internal Wiring
Let’s discuss in detail about the important requirements of above-mentioned Classifications.
Fixing of Components:
The Components of Medical
Electrical shall be mounted securely to prevent the unwanted movement that
could result in an unacceptable risk.
Fixing of Wiring:
The Conductors and Connectors
of Medical Electrical Equipment shall be secured and insulated. The accidental
detachment of Conductors and Connectors shall not result in a Hazardous
Situation.
Connections between different
parts of Medical Electrical
Equipment:
The Flexible Cords used for interconnection of
different parts of Medical Electrical Equipment that are detachable without
using the tool shall have a means of connection such that there is no
compromise in the compliance of Metal Accessible Parts with the requirements of
Clause 8.4 of IEC 60601-1 when a connection is loosened or broken due to the
disengagement of one of the connecting means.
Cord Connected Hand-Held parts and Cord Connected foot
operated control devices:
Only the Conductors and
Components which are operating at the voltages not exceeding 42.4 Peak Voltage
AC and 60 Voltage DC in circuits isolated from the Mains Part by Two Means of
Protection shall be present in the Cord Connected Hand-Held and Foot Operated
Control devices of the Medical Electrical Equipment and their associated
connection cords.
Mechanical Protection of Wiring:
The Adequate protection shall be provided for
Internal Cables and Wiring against contact with the moving part or from
friction at sharp corners and edges.
The Wiring, cord forms or the components of
Medical Electrical Equipment shall be designed such that there shall not be any
damage during the opening and closing of access covers or during the assembly.
Guiding rollers for Insulated Conductors:
In Medical Electrical Equipment, the Guiding rollers of insulated
conductors shall be constructed in a such a manner that in Normal Use, the
movable insulated conductors are not bent round a radius of less than 5 times
the outer diameter of the concerned lead.
Insulation of Internal Wiring:
The Adequate protection shall be provided for
the insulating sleeving present in the internal wiring of the Medical
Electrical Equipment. The Sleeving which can be removed only by breaking or
cutting shall be used to satisfy this requirement. The Sleeving that is secured
at both ends shall also be used.
The Sheath of flexible cord present inside the
Medical Electrical Equipment shall not be considered as a Means of Protection
when it is exposed to thermal or mechanical stress outside of its rated
characteristics.
During Normal Use, the Insulated Conductors of
Medical Electrical Equipment shall experience a temperature exceeding 70 °C.
So, the Insulated Conductors shall have an insulation of Heat Resistant
Material because the deterioration of the insulation shall result in a
Non-Compliance of the requirements of IEC 60601-1.
Now I hope you have acquired some knowledge about IEC 60601-1 Sub Clause 8.10: Components and Wiring. 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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