Hi friends!!!

In our previous blogs, we have discussed about the following topics.

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 8.5: Separation of Parts as per IEC 60601-1.

Let’s get into the topic.

Separation of Parts

Means of Protection:

General:

The Applied Parts & Accessible Parts of Medical Electrical
Equipment shall have two means of protection to prevent from exceeding the
limits specified in “Section 8.4 Limitation of voltage, current or energy” of
IEC 60601-1.

The Two Means of Protection are following:

Means of Patient Protection (MOPP):

MOPP reduces risk of electric shock to patients.

Means of Operator Protection (MOOP):

MOOP reduces risk of electric shock to persons other than the patients.

The following shall not be regarded as a Means of Protection:

Varnishing

Enamelling

Oxidation

Similar protective finishes

Means of Patient Protection (MOPP) & Means of Operator
Protection (MOOP):

The following are the requirements of MOPP & MOOP:

Dielectric Strength Test according to Section 8.8 of IEC 60601-1
shall be complied for Solid Insulation forming a Means of Patient Protection or
Means of Operator Protection in Medical Electrical Equipment.

The Limits specified in “Table 12 – Minimum Creepage Distances and
Air Clearances providing Means of Patient Protection” of IEC 60601-1 shall be
complied for Creepage Distances and Air Clearances forming a Means of Patient
Protection in Medical Electrical Equipment.

The Limits specified in “Table 13 – Table 16” shall be complied for
Creepage Distances and Air Clearances forming a Means of Operator Protection in
Medical Electrical Equipment.

The requirements of Section 8.6 of IEC 60601-1 shall be complied
for Protective Earth Connections forming a Means of Patient Protection or Means
of Operator Protection in Medical Electrical Equipment.

Separation of Patient Connections:

F Type Applied Parts:

The Patient Connections of any F-Type Applied Part shall be
separated from all other parts of the Medical Electrical Equipment, including
the Patient Connections of other Applied Part, by one Means of Patient
Protection for the Working Voltage equal to the Maximum Mains Voltage. The One
Means of patient Protection shall also comply with the specified Patient
Leakage Current limits of 110% of the Maximum Mains Voltage.

There might be multiple functions in a single F Type Applied Part.
In this case, it is not required to have a separation between such functions.

If the Patient Connections does not have an electrical separation
between the same or another function, then these Patient Connections are
considered as one Applied Part.

The Type BF, Type CF or Defibrillation-Proof classifications applies
to the whole of one Applied Part.

B Type Applied Parts:

In Medical Electrical Equipment, the Patient Connections of a Type
B Applied Part which are not Protectively Earthed shall be separated from metal
Accessible Parts which are not Protectively Earthed by one Means of Patient
Protection.

The above-mentioned requirement shall not be necessary if the risk
of metal Accessible Part making contact with the source of voltage or Leakage
Current above permitted limits is acceptably low and if the metal Accessible
Part is physically touching the Applied Part and can be considered as a part of
the Applied Part.

Patient Leads or Patient Cables:

Any connector for electrical connections to the patient lead which
is connected at the end of the lead or cable that is remote distal from the patient
shall be constructed so that the said part cannot become connected to earth or
possible hazardous voltage while the Patient Connections contact the Patient.

Likewise, any connector for electrical connections to the patient lead
which contains a conductive part that is not separated from all Patient
Connections by one Means of Patient Protection for a Working Voltage equal to
the Maximum Mains Voltage, shall be constructed so that the said part cannot
become connected to earth or possible hazardous voltage while the Patient
Connections contact the Patient.

Now I hope you have acquired some knowledge about IEC 60601-1 Sub Clause 8.5: Separation of Parts. 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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