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
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 4: General Requirements as per IEC 60601-1.
Let’s get into the topic.
Clause 4 – General Requirements
The Clause 4 of IEC 60601-1 states the General requirements of Medical Electrical Equipment. The following are the Sub-Clauses.
Conditions for application to Medical Electrical Equipment or Medical Electrical Systems.
Risk Management Process for Medical Electrical Equipment or Medical Electrical Systems.
Essential Performance.
Expected Service Life.
Alternative Risk Control measures or test methods for Medical Electrical Equipment or Medical Electrical Systems.
Medical Electrical Equipment or Medical Electrical System parts that contact the Patient.
Single Fault Condition for Medical Electrical Equipment.
Components of Medical Electrical Equipment.
Use of Components with High-Integrity Characteristics in Medical Electrical Equipment.
Power supply.
Power input
Let’s discuss in detail about Important requirements of above-mentioned Sub Clauses.
Risk Management Process for Medical Electrical Equipment or Medical Electrical Systems:
Risk Management Process complying with ISO 14971:2019 shall be performed & required. The requirements of IEC 60601 shall not be satisfied unless complying with the requirements of ISO 14971. The Compliance to IEC 60601 in many cases is checked by inspecting the Risk Management File.
Essential Performance:
Essential Performance means a performance, of a clinical function, other than that related to Basic Safety, where loss or degradation beyond the limits specified by the manufacturer results in an unacceptable risk.
During Risk Analysis, the manufacturer shall identify the Essential Performance of the Medical Electrical Equipment or Medical Electrical Systems. The manufacturer shall specify performance limits between fully functional & total loss of the identified performance in both the Medical Electrical Equipment or Medical Electrical Systems under Normal Condition & Single Fault Condition.
Expected Service Life:
The Expected Service Life shall be stated in the Risk Management File by the Manufacturer.
Alternative Risk Control measures or test methods for Medical Electrical Equipment or Medical Electrical Systems:
The Alternate Risk Control measures or Test Methods apart from those that are specified in IEC 60601-1 shall be used until the residual risk arising from such alternate risk control measures or test methods is relatively low when compared to the risk control measures or test methods specified in IEC 60601-1.
Medical Electrical Equipment or Medical Electrical System parts that contact the Patient:
The Risk Management Process shall determine the parts which come in contact with the patient apart from the parts which are specified as Applied Parts. Such parts shall also confirm to the requirements of applied parts and are considered as Type B Applied Part unless and otherwise identified as Type BF Applied Part or Type CF Applied Part.
Components of Medical Electrical Equipment:
All components of Medical Electrical Equipment including the wiring shall be used as per their specified ratings. The reliability of the components which are used as a Means of Protection shall be tested based on the conditions of use in the Medical Electrical Equipment.
Power supply:
The Medical Electrical Equipment shall be suitable to use in connection with supply mains. The Rated Voltages for Supply Mains shall be 250v for Handheld Devices and 500v for other Medical Electrical Equipment or Medical Electrical Systems.
Power input:
The measured Power input of Medical Electrical Equipment or Medical Electrical System at a specified Rated Voltage and Operating conditions shall not exceed the marked Power input rating by more than 10%.
Now I hope you have acquired some knowledge about IEC 60601-1 Clause 4: General Requirements. We will meet again with another valuable topic related to Biomedical Engineering, Medical Device, Healthcare.
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