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 Clause 13: Hazardous situations and fault conditions for Medical Electrical Equipment as per IEC 60601-1.

Let's get into the topic.

Clause 13 – Hazardous Situations and fault

conditions for Medical Electrical Equipment

The Clause 13 of IEC 60601-1 states the requirements of Hazardous situations and fault conditions for Medical Electrical Equipment. The following are the Sub-Clauses.

Specific Hazardous Situations
Single Fault Conditions

Specific Hazardous Situations:

The Specific Hazardous Situations shall be further classified as following.

Deformation of enclosure, Emissions or exceeding maximum temperature:

The following Hazardous Situations shall not occur:

1. The Emission of molten metal, flames, poisonous or ignitable substances in hazardous quantities.

2. The deformation of Enclosures shall not occur to an extent which can cause a non-compliance with requirements in IEC 60601-1.

3. The Temperatures of Applied Parts shall not exceed the allowed values.

4. The Temperatures of Medical Electrical Equipment parts other than Applied Parts which are likely to be touched shall not exceed the allowed values.

5. The Temperatures of Accessible Parts which are likely to be touched but are not supposed to be touched to operate the Medical Electrical Equipment shall not exceed the allowed values.

6. The Temperatures of Accessible Parts which are supposed to be touched to operate the Medical Electrical Equipment shall the exceed the allowed values mentioned.

Exceeding Leakage Current or voltage limits:

The following Hazardous Situations shall not occur:

1. The allowed limits for leakage current in Single Fault Condition shall not exceed.

2. The allowed voltage limits for Applied Parts and Accessible Parts shall not exceed.

Single Fault Conditions:

During the application of the Single Fault Conditions listed below, the Normal Conditions identified as per IEC 60601-1 shall also be applied in the least favorable combination.

The Single Fault Conditions are as following:

1. Electrical Single Fault Condition

2. Overheating of transformers in Medical Electrical Equipment

3. Failure of Thermostats

4. Failure of temperature limiting devices

5. Leakage of Liquid

The Medical Electrical Equipment shall be constructed in such a way when there is a liquid leakage during a Single Fault Condition, only a small amount of liquid leaks. The sealed rechargeable batteries are exempted from this requirement.

6. Impairment of cooling that could result in a Hazardous Situation

The following are few of examples related to Impairments of cooling that can occur:

The consecutive locking of single ventilation fans.

The covering of ventilation openings in top and sides of the enclosure or the Medical Electrical Equipment’s are placed against the walls.

The blockage of filters.

Interruption in the flow of cooling agent.

7. Locking of Movable Parts

In Medical Electrical Equipment, the moving parts are locked if it has moving Accessible Parts or Applied Parts which are liable to be jammed or liable to be operated when unattended (this includes automatically or remotely controlled Medical Electrical Equipment), or it has one or more motors with a locked rotor torque smaller than the full load torque.

If Medical Electrical Equipment has more than one moving part as described above, only one moving part is locked at a time. If multiple motors can. be locked in a Single Fault Condition, then all motors are locked simultaneously

8. Interruption and short circuiting of motor capacitors

9. Additional test criteria for motor operated Medical Electrical Equipment

10. Failures of components in Medical Electrical Equipment used in conjunction with Oxygen Rich Environments

11. Failure of parts that might result in a Mechanical Hazard

12. Overload

Now I hope you have acquired some knowledge about IEC 60601-1 Clause 13: Hazardous situations and fault conditions for 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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