Hi friends!!!

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

IEC 60601-1 Definitions

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 

EU MDR Assessment Routes

EU MDR Timeline, Annex, Chapter

EU MDR Post Market Surveillance

EU MDR Clinical Evaluation

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 Classification Rules

EU MDR EUDAMED

EU MDR Economic Operators

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 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.

 

1. Specific
   Hazardous Situations
2. 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